VIDD Job Openings

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The Laboratory Center has an annual budget of more than $25 million and employs approximately 200 employees throughout the program. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The HVTN Laboratory Center is seeking an Research Finance Assistant Director.

Responsibilities

The Research Finance Assistant Director is responsible for driving all activities related to financial planning, grants and contracts, bugeting and analysis for the HVTN Laboratory Center, related grants and Division activities. This position will report to Director of Program Operations, Immunology and Vaccine Development (IVD) Program and will be a valued consultant to the Senior Vice President and Director, VIDD/HVTN Principal Investigator. The position will drive the international grants and contracts, budget and planning process for the Laboratory Center, as well as perform financial analysis. This position will provide strategic direction for a long-range financial view of the grant life cycle and beyond, while taking into consideration internal and external variables and constraints. Significant experience in complex sponsored research projects and financial analysis as well as a demonstrated track record as a leader who values teamwork, collaboration and communication are critical for this role. The ability to effectively communicate financial complexities to a range of audiences is essential.

The Research Finance Assistant Director will also manage a small team and will leverage Division and organizational resources to accomplish goals. In addition, this position will work closely with HVTN Leadership Operations Center, HVTN Statistical Data Management Center, Finance and Accounting as well as across functions (Office of General Council, Business Development & Strategy, IT and Human Resources). The position requires an ability to direct and manage multiple priorities, quickly analyze situations and make sound decisions using effective time management skills, good business acumen, and administrative judgment.

A. Financial Strategy and Operations

• Provide direction and support to the Senior Vice President and Director, VIDD/HVTN Principal Investigator, on the financial strategy and planning of the HVTN Laboratory Center and related activities.
• Develop and maintain key reports for reporting performance against the budget, internal and external requirements to drive accountability and transparency. Prepare information and reports that forecast trends, analyze performance results, and address financial concerns.
• Establish and drive the annual budget and planning process including communicating across HVTN programs and Center leadership.
• Oversee and monitor all grant and fiscal activities within the HVTN Laboratory Center Programs including all national and international sites.
• Establish and comply with financial requirements of NIH and/or the specific funding agency as well as Fred Hutch policies.
• Assist the Director of Program Operations-IVD and VIDD Senior Operations Director and in the development of short and long term planning of financial resource management, in monitoring spending levels on accounts, advising them of any change in spending status, and troubleshoot/resolve problems or questions regarding budgets.

B. Team Leadership

• Manage a small team of fiscal staff.
• Establish a regular cadence of HVTN Laboratory Center Financial meetings including the tracking and monitoring of agendas and action items.
• Serve as coordinator and contact between members, study investigators, oversight committee and working group leads on all financial matters.
• Serve as a special advisor to VIDD financial teams for financial management related to sponsored and non-sponsored finance, forecasting and best practice.  

C. Financial Reporting and scientific related visits/meetings

• Coordinate specific reports as requested by the Division of AIDS, NIH (DAIDS)
• Serve as the primary point of contact on all post-award financial activities for sponsor communications in coordination with the Principal Investigator.
• Oversee the submission of the annual progress report including budgets to DAIDS and related reports.
• Maintain communications and track fiscal team group progress. Communicate and track timelines and milestones.
• Create and maintain a system or executive report for portfolio financial reporting for the Senior Vice President and Director, VIDD/HVTN Principal Investigator that includes summary and detailed reports for each grant and active account.
• Develop reports and/or systems that forecast trends, analyze performance results, and address financial concerns.

D. Other Duties

• Continuously improve the budget and forecasting process and reports, including championing data structure and support.
• Assist with financial negotiations related to the Laboratory Center in partnership with Senior Vice President and Director, VIDD/HVTN Principal Investigator, Senior Operations Director, VIDD, Director of Program Operations-IVD, Business Development and Fred Hutch administration, upon request.
• Perform other related duties as assigned including, but not limited to, financial support related to complex agreements, Board reporting and related due diligence.

Qualifications

Minimum qualifications:

• Bachelor’s degree in Accounting, Finance or related field; MBA is preferred.
• 7-10 years of progressively complex experience in research finance and/or administration of department financial processes and systems including a minimum of 5 years experience working with sponsored research (NIH required)
• Minimum three years experience leading a team including direct supervision of staff
• Advanced Excel modeling skills and proficient in MS Office Suite applications
• Excellent oral and written communication skills
• Experience with Tableau and related data presentation software
• Knowledge of NIH grant application procedures, budget monitoring, databases, and financial terms
   

Key skills and abilities

• Excellent attention to detail and the ability to work independently are essential to success in this position, as are good communication and organizational skills
• Ability to work under pressure, and maintain confidentiality
• Ability to prioritize multiple tasks, organize, and work both independently and as part of a team
• Excellent attention to detail and the ability to work independently are essential to success in this position, as are good communication and organizational skills
• Must be flexible and willing to work some evenings and weekends as needed

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Research Associate (SRA) to provide statistical support to laboratory investigators researching HIV and other infectious disease vaccines under the direction of the lead statisticians. This support primarily involves analysis of biomarker data for preclinical, early phase, and post-marketing clinical studies, but can also encompass a variety of statistical requests. The SRA codes primarily in R. In addition to performing the analyses, the SRA communicates with the internal statistical team and external investigators regarding details of the data, analysis plan, and timelines. As part of a larger team of statisticians, programmers, and project managers, the SRA also contributes to an environment of mutual cooperation and respect. The SRA handles multiple projects and works efficiently in a fast-paced environment.

Responsibilities

Under limited technical direction, the SRA applies statistical and programming knowledge to various types of laboratory data and sometimes clinical data, resulting in production of a statistical report and analysis data for distribution. The SRA writes programs that are reproducible, well documented, and reusable for similar types of data. The incumbent works in close collaboration with statisticians and other programming staff within SCHARP. The SRA exercises judgment within defined SCHARP practices and policies. 

Responsibilities may include some or all of the following: 

• Provide statistical analysis, written summaries and tables of results of laboratory data for use in customized statistical lab reports under the direction of other statisticians 
• Clearly communicate statistical concepts and issues to scientists and other non-statisticians 
• Work individually or as part of a team to resolve statistical issues pertaining to the study 
• Brainstorm and perform exploratory analyses with guidance from the lead statistician  
• Prioritize and manage workload on multiple project requests within deadlines 
• Assist in the development of quality control procedures for data analysis 
• Generate standardized code for assay data processing that can be used across studies 

Qualifications

Minimum: 

• Master’s degree in Biostatistics or Statistics 
• 1 year of related experience 
• Background in statistical computing and proficiency with the statistical packages R, as with the development of statistical programs and software 
• Excellent computer skills with the ability to optimize the use of available software 
• Experience collaborating with others to determine what data is needed, what data exists, and how best to extract the data in a useful format 
• Strong oral and written communication skills 
• Organized, detail-oriented, capable of meeting tight deadlines, and work well within a team environment
   

Preferred:  

• Master's Degree in Biostatistics and 4 or more years of related experience
• Experience with laboratory assay data
• Experience with creating Rmarkdown reports
• Experience writing statistical reports
• Experience with Git and GitHub or other version control software

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Research Associate (SRA) who will provide statistical support, which may include reviewing protocol drafts, participation on the protocol development team, and assisting the protocol lead statistician in the design of appropriate analyses. The SRA will write statistical analysis plans for protocols and complete the analysis.

Responsibilities

The incumbent works independently designing, developing, coordinating and performing statistical aspects of study design, implementation, and analyses for clinical trials. The incumbent serves as lead on more than one protocol and may provide mentorship to at least one other SRA. The incumbent works well under pressure, has established a positive and productive working relationship with faculty statisticians and/or industry partners and exercises good judgment with defined practices and policies. Technical skills are strong and reliable, and productivity is high demonstrated by attention to detail, compliance with regulations and best practices, and adherence to deadlines.  

Responsibilities may include some or all of the following:  

• Provide statistical analyses in the form of tables, listings, and figures and/or written summaries of study data and results for use in reports, for example, Data and Safety Monitoring Board meetings, scientific papers, or tables in support of a Clinical Study Report for submission. 
• Review protocol drafts .
• Participate in describing and defining statistical considerations in study protocols (ex: sample size/power/analysis models) .
• Participate in the development of statistical analysis plans. 
• Participate in the development of quality assurance procedures for on-going data collection and analysis, such as establishing edit checks, or HIV endpoint verification. 
• Participate in the development and verification of randomization lists.
• Provide input into the development of case report forms. 
• Collaborate with programmers in production and verification of standard reports. 
• Coordinate production of statistical reports in accordance with CDISC data standards and guidelines.
• Assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides).
• Participate in protocol team conference calls and meetings. 
• Provide statistical consultation for research projects. 
• Archive statistical files and documents. 
• Evaluate new statistical software packages. 
• Represent statistical unit at study organizational meetings.  
• Represent study at scientific meetings.  
• Give oral presentations of study results.  
• Assist other statistical research associates with statistical analyses. 
• Collaborate with internal PhD statisticians/epidemiologists and external subject-matter experts to perform statistical analyses of clinical trials data for production of abstracts and manuscripts. 
• Perform other responsibilities as required. 

Qualifications

Required:

• A master's degree in Statistics or Biostatistics or related field.
• A minimum of three years of experience working in clinical trials.
• Proficiency in statisitcal computing including SAS and R.
• Excellent oral and written communication skills.
• Ability to effectively collaborate with internal and external colleagues in a team environment.

Preferred:

• Proficiency in programming statistical reports using CDISC data standards.
• Experience in producing statistical reports in suport of an FDA submission.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Research Associate (SRA). The SRA will provide statistical support, which may include reviewing protocol drafts, participation on the protocol development team, and assisting the protocol lead statistician in the design of appropriate analyses. The SRA will write statistical analysis plans for protocols and complete the analysis.

Responsibilities

Provides intermediate-level statistical support to clinical trials and research in the planning, operational, monitoring, analytic, and exploratory stages.

Responsibilities may include some or all of the following:

• Provide statistical analysis, written summaries and tables of results for use in project reports, including Data and Safety Monitoring Board meetings, scientific papers, or tables in support of a Clinical Study Report for submission

• Review protocol drafts

• Participate in describing and defining statistical considerations on study protocols, including sample size and power analyses

• Participate in the development of statistical analysis plans

• Participate in the development of quality assurance procedures for on-going data collection and analysis, such as establishing edit checks, or HIV endpoint verification

• Participate in the development and verification of randomization lists

• Participate in verification of standard reports prepared by programmers

• Provide input into the development of case report forms

• Collaborate with SCHARP data management and operations groups to ensure that accurate data reaches statisticians for analysis

• Participate in the production of statistical reports in accordance with CDISC data standards and guidelines

• Assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides)

• Participate in protocol team conference calls and meetings

• Provide statistical consultation for research projects

• Archive statistical documents

• Evaluate new statistical software packages

• Represent statistical unit at study organizational meetings 

• Represent study at scientific meetings 

• Give oral presentations of study results 

• Assist other statistical research associates with statistical analyses

• Collaborate with network/SDMC PhD statisticians/epidemiologists and external subject-matter experts to perform statistical analyses of clinical trials data for production of abstracts and manuscripts

• Maintain functional understanding of standard procedures and complete required training in a timely manner

• Perform other responsibilities as required

Qualifications

• Master's or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience.

• A minimum of one year of related experience is required for the biostatistician II level, whereas at least three years of experience is required for the biostatistician III level

• Proficiency with the SAS or R (as required by specific team/project)

• Strong oral and written communication skills

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Clinical Data Manager (CDM).

The CDM leads and monitors the collection, processing, data entry and quality control of study data. They are responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. They develop and maintain successful working relationships with their team and specific research sites to ensure and maintain data integrity and quality. The CDM works within a network/study/protocol team to support the policies and goals of each project assigned. Applying GCP and GCDMP principles, the CDM manages the protocol/study specific tasks including coordinating clinical and laboratory database deliverables, working with collaborators on data content requirements, leading data quality and closeout activities throughout the data management lifecycle. The CDM adheres to SCHARP Standard Operating Procedures (SOPs), Work Practice Guidelines (WPGs), applicable clinical trial regulations, and study confidentiality requirements and functions with moderate supervision in operational and technical matters within defined procedures and practices.

**Please note: This position will be on-site in Seattle, WA. We cannot accommodate a remote worker in this role at this time.

Responsibilities

The Clinical Data Manager (CDM) will manage study/protocols with moderate supervision from senior staff and/or departmental leadership and will use judgment in making decisions regarding routine data management, quality control and liaison tasks. The CDM is the primary SCHARP contact for study/protocol specific implementation, operation, and closeout phases and is responsible study communication, documentation, and training on data collection and management activities for domestic and international research sites for assigned protocol/study(s).   The CDM is a member of the protocol/study team coordinating with both internal and external partners and collaborators to ensure the relevant data are collected and cleaned to meet the needs of the protocol/study and research objectives.

For the more experienced CDM, they may participate in training and orientation of new CDMs when appropriate, and may serve as a CDM mentor. Assignment of projects/trials is commensurate with previous experience and can be assigned across scientific areas or study phases. They will be coordinating larger, more complex studies and/or a larger volume of studies with minimal assistance.

• Manages study/project implementation including but not limited to leading SCHARP team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training.
• Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.
• Ensure rapid resolution of issues/problems using appropriate internal and/or external resources. Track and manage issues escalating to the appropriate level in a timely manner.
• Participate in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.
• Work with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, staffing requirements, organization and approach.
• Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies.
• Assist in development of Case Report Forms (CRFs) for assigned studies.
• Assist in the design of the protocol/study specific database for assigned studies.
• Assist in the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies.
• Perform User Acceptance Testing (UAT) for assigned studies.
• Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures.
• Generate QC reports for site review and correction as well as a variety of other reports as required.
• Evaluate study data for protocol compliance.
• Assist in the maintenance of documentation of the study database and other related data management programs and/or applications.
• Assist in the review of new and revised departmental SOPs and WPGs.
• Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP).
• Perform other duties as assigned.

Qualifications

Minimum:

• Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline
• 2+ years’ experience in the pharmaceutical/clinical research environment as a Clinical Data Coordinator/Clinical Data Manager
• EDC experience required. Working knowledge of Medidata Rave highly desirable. Demonstrated expertise in relevant clinical data management activities.
• Working knowledge of ICH/GCP guidelines and FDA regulations.
• Familiarity with all phases of clinical trials and ability to adapt to study requirements.
• Strong verbal and written communication skills. Ability to understand and follow instructions and guidelines; able to pick up new tasks quickly; willing to ask questions when a task is not fully clear.
• Ability to exercise independent judgment within generally defined practices and policies. Shows good judgment in interpreting guidelines and when to seek support.
• Ability to work independently and to work efficiently under pressure. 
• Consistent, dedicated, versatile and able to prioritize and multi-task.
• Familiarity with MS Office software and familiar with data management practices.   
   

Preferred:

• 4+ years' experience in the pharmaceutical/clinical research environment as a Clinical Data Manager.
• Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle)
• Experience in clinical trial and regulated research settings desired. Experience with managing immunology, infectious disease and/or virology research projects desired.
• Prior experience in HIV or infectious diseases, clinical trial operation management and/or protocol development preferred.
• Experience in facilitating and building consensus in an interdisciplinary team environment and able to build successful working relationships with a wide variety of collaborators.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Director, Clinical Data Management (CDM) to provide overall leadership and management of the clinical data management and safety teams (consisting of approximately 40 employees) and direct supervision of CDM managers, the manager of Clinical Safety and Coding, and other CDM staff as needed. The incumbent will be responsible for ensuring that the CDM teams are operating efficiently and effectively and that they meet the requirements of the research protocols in a regulatory compliant manner. Director, Clinical Data Management will also work closely with SCHARP’s Executive Director, Managing Director and Senior Management Team to create and implement the overall organizational strategic direction, project plans, and initiatives.

Responsibilities

Leadership

• Provide overall strategic, organizational, and operational management and guidance to the CDM group.
• Collaborate with the SCHARP Executive Director and other unit Directors to create and implement overall organizational vision and strategic direction.
• Foster and promote the long-term development of the CDM team, work closely with the SCHARP Executive Director, Senior Management Team, and the CDM managers to improve the operational effectiveness of the group.

Management

• Directly supervise Clinical Data Management and Safety and Coding managers, and other CDM staff as needed.
• Provide training, direction and performance management for individual employees and work with Fred Hutch Human Resources staff to facilitate recruiting efforts and staffing changes as needed.
• Develop and maintain CDM staff morale, engagement, and professional development.
• Monitor group project and protocol workflows, priorities, timelines, deliverables, documentation and resources and communicate issues regarding conflicts and/or resource limitations.
• Provide technical and functional oversight of the day-to-day work and work products of clinical data management staff, as needed, including clinical data collection, processing, and quality control procedures, timelines and documentation.

Change Management and Quality Assurance

• Lead departmental efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, and ICH guidelines, and that meet regulatory submission requirements, and CDISC standards.
• Oversee and ensure quality assurance of CDM in coordination with the Quality Management section.
• Prioritize and manage the implementation of SCHARP continuous quality improvement, regulatory compliance, operational effectiveness, and technical infrastructure improvement projects in clinical data management.
• Evaluate and identify efficiencies and process improvements including leading process improvement projects, and infrastructure and technological upgrades to improve CDM intake, workflow, documentation, tracking, and protocol management

Qualifications

Minimum:

• Bachelor’s degree in related field and a minimum of 10 years of experience in clinical research, data management or related field, of which 4 years is in a leadership or management role, or equivalent combined years of education and experience.
• Demonstrated leadership, management, supervisory, and collaboration skills across functions to drive effective and efficient Clinical Data Management practices.
• Excellent project management and organizational leadership and change management experience.
• Experience in the development and use of commercial clinical data management. Systems and/or EDC products.
• Advanced knowledge of clinical research, FDA, ICH, GCP, GCDMP, and related regulatory requirements and best practices.

Preferred:

• Graduate Degree in life sciences or related disciplines.
• 10+ years management experience in a clinical research organization.
• Organization strategic planning experience.
• Working knowledge of CDISC / CDASH, MedDRA coding, and Medidata Rave EDC.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Regulatory Coordinator works with faculty and staff in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to ensure all regulatory compliance measures are followed for clinical trials by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues. 

The Regulatory Coordinator works on the Infectious Disease Sciences Program’s IRB and Regulatory team reporting to the team manager/supervisor. The position is expected to work independently within a framework of established regulations and guidelines, and demonstrate initiative and sound judgment in problem solving, providing regulatory guidance and developing policies and procedures. This position has significant interactions with the PI(s), other team members, internal departments and external organizations and agencies. 

Responsibilities

• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations.
• Maintain study regulatory binders and electronic files g. SharePoint, OneDrive, OnCore.
• Perform internal audit and quality assurance checks on regulatory documents.
• With input from PIs, study team, draft initial clinical research informed consent forms and study documents.
• Lead study start-up; prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual.
• Prepare and present materials for monitoring visits; may serve as primary point of contact during visits.
• Independently follow-up and resolve all issues related to regulatory concerns identified during monitoring visits.
• Prepare and submit modifications/amendments, and continuing renewals for ongoing study maintenance in a timely manner.
• Conduct study close-out. Be responsible for archiving regulatory documents/records, ensuring that all files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and program SOP.
• Process IND external safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
• Report non-compliance and unanticipated problems to the IRB as applicable.
• Serve as primary regulatory resource for PIs, sponsors, a study team, providing guidance on regulatory statuses, approvals and instructions regarding patient consent.
• Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.)
• Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team. Work with IRB team and IDS leadership to develop standard operating procedures (SOPs).
• Identify, develop and implement any necessary revisions to related policies and procedures.
• Work with fiscal team/PI/study team regarding funding proposals, annual progress reports.
• Coordinate and manage the regulatory documents from each participating sites for studies where IDS serves as the IRB of record (coordinating center). Also track sites’ annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.

Qualifications

Minimum qualifications:

• Associates or Bachelor’s degree and a minimum two years of regulatory, human research protection or related experience in a research environment. 
• Demonstrated knowledge of regulatory guidelines (IB, IACUC, MUA, etc.), knowledge of FDA, GCP and NIH requirements, ability to interpret and synthesize regulations and guidelines.
• Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills, and the ability to reach and reconcile data in reports. 
• Ability to use discretion and maintain confidentiality. 
• Proficiency with MS Office suite.

Preferred qualifications:

• Certified IRB Professional (CIP) certification

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Lab Data Coordinator. The Lab Data Coordinator (LDC) monitors the collection and processing of and performs routine data entry and quality control of laboratory specimen and assay data pipelines at the Statistical Center for HIV/AIDS Research and Prevention (SCHARP). The LDC will work within a network/study/research protocol team to support the policies and goals of each project assigned study or project. The incumbent will develop and maintain successful working relationships with protocol their teams and specific research sites to ensure and maintain data integrity and quality.

Responsibilities

The Lab Data Coordinator will be part of a team of data coordinators and data managers who work closely with programmers to oversee all SCHARP laboratory data pipelines. The incumbent will work under the supervision of the Lab Data Management leadership and the mentorship of the Sr. Lab Data Coordinators and lab data managers. They will refer all non-routine decisions for the management of data to study/protocol leads and/or departmental leadership. Responsibilities may include:

• Attend study team meetings and conference calls and with guidance, serve as a LDM representative
• Serve as a liaison between SCHARP study teams and external collaborators to establish and monitor specimen data pipelines and assay data from clinical trials and associated specimen repositories
• Oversee and distribute standardized specimen data discrepancy reports
• Work with external labs, SCHARP lab programmers and clinical data managers to investigate and resolve data discrepancies and troubleshoot issues as needed
• Identify opportunities for process improvements and collaborate to develop and implement solutions
• Work with SCHARP lab data managers, specialists and programmers to develop specifications / requirements for lab data management processing and quality control systems
• Act as a liaison between the SCHARP lab data management unit and clinical research sites or external labs; and with supervision represent LDM on SCHARP study teams and in internal and external meetings.
• Help maintain lab, assay and specimen metadata
• Respond to and resolves quality control queries from labs
• Provide operational support to labs for tools that SCHARP maintains and operates, including Atlas and custom SCHARP tools
• With supervision, develop Data Transfer Plans (DTPs) and other documentation associated with specimen and assay data transfers
• Escalate issues to the Lab Data Management leadership as needed
• Adhere to quality assurance procedures, standard operating procedures, and work practice guidelines and support documentation of these efforts

Qualifications

• Bachelor’s degree in biological sciences, or equivalent
• Minimum 2 years of clinical or lab data management experience
• Demonstrated ability to work independently and as part of a team
• Demonstrated ability to manage multiple projects and competing priorities
• Must be flexible, work well in a team environment, and be capable of meeting tight deadlines
• Must be organized and detail-oriented, with excellent oral and written communication skills

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking is seeking a Lead Data Standards Analyst. Under minimal supervision, the Lead Data Standards Analyst oversees the coordination and management of clinical data standards and production of standard datasets within SCHARP. The incumbent provides subject matter expertise in CDISC data standards, leads coordination efforts with SCHARP staff and network partners to standardize the collection and tabulation of clinical trials data, chairs the Data Standards Committee to govern CRF alignment with CDASH and change control for SCHARP SDTM and ADaM specifications, trains others in CDISC standards and SCHARP dataset configurations, reviews and approves draft SDTM and ADaM metadata and conversion specifications prior to implementation, configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse, and may supervise Data Standards Analysts in support of above described activities.

Core to the role is a deep understanding of data standards and data transformations, the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect.

Responsibilities

• The Lead Data Standards Analyst ensures that SCHARP studies produce high-quality CDISC datasets aligned with SCHARP standards and compliant with the latest published electronic regulatory submissions standards including:
  • CDISC Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML.
  • Controlled Terminology (CT) published by CDISC and NCI, as well as SCHARP-defined terminology
  • Electronic Common Technical Document (eCTD), Study Data Standards Documents, and other electronic submissions guidance issued by drug and medical device governing authorities.
• As Chair of the Data Standards Committee, governs the process for maintaining organizational data standards for clinical data collection, management, and reporting.
• Reviews and approves the draft of SDTM and ADaM metadata and conversion specifications prior to the implementation of these specifications in the clinical data warehouse.
• Configures data transformations to provision SCHARP SDTM data tables from CRF and other data pipelines to SCHARP Programmers and Statistical Research Associates via a clinical data warehouse.
• Provides oversight to the SCHARP SDTM and ADaM data specifications – the operating clinical data models used for reporting and deriving clinical datasets and analysis datasets, respectively.
• Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP SDTM and advises to others in SCHARP on CDASH and ADaM.
• Works with study teams to lead the definition and documentation of per study SDTM metadata and conversion specifications and ensures alignment with organizational data standards.
• Provides study teams with insight to the SCHARP ADaM data specifications.
• Defines and documents per study clinical data transformations to SDTM+- from data collection formats such as CDASH.
• Implements clinical data transformations of source data to SCHARP SDTM using database ETL tools. Specifies complex transformations and consults with Programmers, as needed, to implement.
• Reviews and validates derived SCHARP SDTM and ADaM datasets using Pinnacle 21 to ensure compliance with published specifications and industry and regulatory requirements.
• Works with IT to identify and recommend enhancements to the database ETL toolset.
• Coordinates and may provide internal CDISC training to SCHARP and our partners as appropriate.
• Provides supervision and leadership by training and mentoring others involved with CDISC standards, SCHARP dataset configurations, and regulatory and/or sponsor specific data requirements.

Qualifications

Minimum qualifications

• Bachelor’s degree in Library Sciences, Informatics, Information Systems, Computer Science or other relative discipline
• Five years of industry experience developing and implementing CDISC data standards
• Working knowledge of CDASH, SDTM and ADaM
• Excellent written and verbal communication skills, with the ability to work well in multi-faceted teams
• Experience working with data documentation formats such as CSV, JSON, and XML
• Expertise using Microsoft Excel

Preferred qualifications

• Experience building transformation pipelines using modern ETL tools such as IBM InfoSphere DataStage, Pentaho/Kettle, SQL Server Integration Services, or other
• Experience supervising or mentoring others
• Experience programming with a modern procedural, declarative, or statistical programming language such as SAS, Perl, Python, Shell or SQL
• Experience working in an environment governed by Good Clinical Practices, Good Clinical Data Management Practices, or other FDA guidelines
• Experience with Electronic Data Capture (EDC) systems

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Lead Software Developer with professional experience to add to our development team.

Responsibilities

• Lead development teams and facilitate design decisions 
• Create and maintain technical specifications and architecture documents 
• Implement and maintain systems within a validated software development lifecycle 
• Participate in agile requirements gathering, design and tasking 
• Provide operational support for existing systems 
• Work on a project team with customers, business analysts, project management and testers 
• Work on a development team creating and following standards that help with cross training and reducing system maintenance tails 

Qualifications

Minimum: 

• 5+ years professional experience in software development 
• Expertise with modern OOP programming paradigms / languages 
• Experience with relational data modeling: conceptual and physical 
• Defining and writing automated unit and functional tests 
• Detail oriented including the following: 
  • Ability to understand a system of complex interactions
  • Capable of deep troubleshooting and discovering root causes of problems
  • Writes unit tests with the same care as product code
  • Has well-commented code 

Preferred: 

• Java full stack web application development experience, both front-end and back-end 
• Agile development 
• UNIX systems 
• PostgreSQL 
• Javascript, Selenium 
• Play Framework 
• Microservice architecture 
• Docker, Kubernetes, AWS 
• Functional programming
• Working in a regulated environment such as 21 CFR Part 11, Sarbanes-Oxley or HIPPA 

Culture: 

• Work in an organization that strives to make the world a better place.  
• Work with developers who enjoy crafting quality code and robust performant systems.  
• Work in vibrant South Lake Union Seattle.  
• Strong commitment from management to a 40 hour work week.  
• Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan. 

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Gottardo Lab is a Research Lab within the Computational Biology department at the Fred Hutchinson Cancer Research Center. We develop statistical methods and computational tools for managing and analyzing high-throughput biological data including single-cell RNA-seq, flow-cytometry, CyTOF and CITE-seq, to name a few. We then utilize these tools, in collaboration with immunologists and clinicians, to analyze high-dimensional data from pre-clinical and clinical trials in an effort to accelerate the development of new cancer immunotherapies and vaccines. Our lab participates in large collaborative efforts funded by the NIH, Gates Foundation and the CZI including the Human Immunology Project Consortium, the Human Cell Atlas, the Cancer Immunotherapy Trial Network and the Collaboration for AIDS Vaccine Discovery.

As a lab, we value inclusion and a diversity of backgrounds and perspectives to inform our work. We believe in supporting each other through mentorship and providing resources for professional development. Given these values, we strive to make our recruitment and promotion processes fair and transparent. Therefore, we strongly encourage all individuals with an interest in the position to apply. To learn more about our lab visit rglab.org.

Responsibilities

• Develop statistical and computational methods for analyzing and integrating high dimensional single-cell data generated by cutting-edge technologies including single-cell RNA-seq, CITE-seq, flow cytometry and CyTOF
• Work with immunologists and clinicians to apply these tools in the context of cancer immunotherapy and vaccine development.

Qualifications

Minimum qualifications:

• Recent PhD degree in statistics/biostatistics, computer science, or other fields with strong quantitative training or experience
• Strong programming skills in C/C++, R or similar languages
• Ability to communicate effectively and work in a team-based setting

Preferred qualifications:

• Background in Biology
• Previous experience with genomics or immunological data analyses
• Experience with good software development practices (e.g. design, unit tests, documentation, code review) for reproducible science

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Responsibilities

The Jerome Laboratory in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center is recruiting a Post-Doctoral Fellow to conduct laboratory bench research to evaluate HIV cure strategies, gene therapy, and methods to assess the latent cell reservoir.  Approaches to be used include genome editing, cell culture, multi-color flow cytometry, biochemical analysis, next-generation sequencing, and others. In addition to performing bench experiments, the individual is expected to help write manuscripts, grant proposals and present research at scientific meetings.

Qualifications

• Seeking a candidate with a Ph.D. in the field of Immunology/Virology. 
• Knowledge of molecular biology, primary cell/HIV culture preferred.
• Must have viral work experience.
• Experience with multi-color flow cytometry.
• Gene editing experience preferred.
• The candidate should be a self-starter and be able to work independently in a team environment. 
• Strong analytical, writing, communication, and problem solving skills are desired. 

A statement of research interests and/or a cover letter are required. Salary will be commensurate with (appropriate) experience.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

There is an opening for a post-doctoral fellow to work on multi-modal single cell analysis and software infrastructure in the lab of Dr. Greg Finak at the Fred Hutchinson Cancer Research Center in Seattle, WA.

About the Lab

We are part of the RGLab, the Biostatistics, Bioinformatics, and Epidemiology program and the Vaccine and Infectious Disease Division of Fred Hutch in Seattle. We develop statistical methods and software tools for the analysis of high throughput biological data with an emphasis on immunology and vaccine research. We work with bench scientists and clinicians to understand and ultimately help develop vaccines and/or cure severe diseases such HIV, malaria, and cancer. We are a diverse group, with training in Statistics, Computer Science, Web Development, Bioengineering, Bioinformatics, and Computational Biology. Learn more about us at rglab.org and see some of our work on GitHub (github.com/RGLab).

Responsibilities

Dr. Finak is seeking a post-doctoral fellow to develop multi-modal (Ab-Seq, CITE-Seq, etc) single-cell assay data infrastructure and analysis as part a CZI Seed Network award to the Bioconductor consortium. The successful candidate will work with a motivated team to develop & implement single-cell specific data structures for storing, manipulating and interacting with multi-modal assay data such as Ab-Seq and CITE-seq, which enable simultaneous measurement of protein and RNA from the same single cell. The candidate will also work to adapt single-cell analytics methods developed in the lab (MAST https://doi.org/10.1186/s13059-015-0844-5 , FAUST

https://doi.org/10.1101/702118) to work with these data types. The candidate is expected to adhere to good software development practices (e.g. design, unit tests, documentation, code review), and participate in regular team meetings.

Qualifications

To be considered, candidates must have:

• PhD in Bioinformatics, Computer Science, Computational biology or equivalent field.
• R (advanced) and C++ (intermediate).
• Unix-alike operating system environment (intermediate)
• R package development (intermediate)
• Bioconductor stack (advanced)
• Software version control (e.g. git working knowledge or greater)
• Candidate should have a strong work ethic and analytical skills, an ability to work in a team, to meet deadlines and to deliver a robust, well-tested and well-documented, quality codebase

Preferred Qualifications

• Track record of contributions to open source software projects.
• Excellent written and oral communication skills.

To Apply:

Please apply with your CV and a letter summarizing your research interests.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Responsibilities

The Corey Laboratory in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center is recruiting a Post-Doctoral Fellow to conduct laboratory bench research using state-of-the-art technologies for developing CAR T cells for the treatment/ eradication of HIV using the NHP, SHIV and SIV model. This project is entering the stage of  using recently developed constructs to be placed into challenge studies with NHP. Development of release assays to measure CAR T cell killing in vitro and in vivo; trafficking are involved. Experience in growing primary T cells working in NHP and flow cytometry are desired.   

Qualifications

Seeking a candidate with a Ph.D. in the field of Immunology/Virology and experience in a related area. Must be knowledge of molecular techniques. The candidate should be a self-starter and be able to work independently in a team environment. Strong analytical, writing, communication, and problem solving skills are needed.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The McGuire Lab is seeking outstanding post-doctoral fellows to work on a project involving the validating and testing of antibodies to prevent infection with Epstein-Barr virus; an important cancer associated pathogen.

Responsibilities

The successful candidate will design and execute antibody-mediated protection studies in in small animals and non-human primates to evaluate the efficacy of antibodies, both passively delivered and vaccine-elicited, to prevent infection and/or EBV-associated cancers. The incumbent will perform endpoint analyses including serum antibody neutralizing titers, assays for detecting viral infection, and analyzing immune responses to treatment/vaccination.

Qualifications

Required:

• PhD in immunology, microbiology, cell biology, or a related field
• Experience conducting in vivo studies in murine models, preferably immune analysis
• The candidate should have a strong virology background
• Must be willing to work flexible hours as needed
• Be independent, show initiative, willingness to take up new skills and responsibilities, and be a team player
• Excellent attention to detail, good communication, and organizational skills are essential to success in this position
• The candidate must be self-motivated, able to multitask and to work within a very collaborative environment.

Please submit a cover letter with your application discussing your interest in the role and future career goals.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The McGuire Lab is seeking outstanding postdoctoral fellows to work on a project involving the validating and testing of novel vaccine candidates to elicit broadly neutralizing antibodies against HIV-1.

Responsibilities

The successful candidate will design and execute prime-boost immunization regimens in a humanized murine model which will serve as a surrogate for human vaccine trials. The candidate will perform endpoint analyses including antigen-specific B cell sorting and serum antibody binding and neutralization assays to gain a high-resolution understanding of the immune response to immunization. To complement this analysis the candidate will perform single B cell sorting of human PBMC samples ascertain the identity of antigen-reactive naïve B cells. 

Qualifications

Required:

• PhD in immunology, microbiology, cell biology, or a related field
• Experience with conducting in vivo studies in murine models, preferably immune analysis 
• Experience with multi-color Flow Cytometry preferred
• Strong molecular biology background
• Willing to work flexible hours as needed
• Must be independent, show initiative, willingness to take up new skills and responsibilities, and be a team player
• Excellent attention, as well as good communication and organizational skills are essential to success in this position
• Must be self-motivated, able to multitask and to work within a very collaborative environment

Preferred:

• Expertise in B cell immunology is highly desirable

Please submit a cover letter with your application discussing your interest in the role and future career goals.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Biostatistics, Bioinformatics and Epidemiology (BBE) at Fred Hutch is recruiting for a Post-Doctoral Position for Statistical and Epidemiologic Methods for Evaluating Vaccines. The postdoc will be supervised by Professor M. Elizabeth Halloran and based at the Fred Hutchinson Research Center in Seattle, WA. The postdoc will be joining a national and international network of researchers who have worked together over many years. The Vaccine and Infectious Disease Division of Fred Hutch has a large group of faculty working on statistical and epidemiologic methods for evaluating vaccines.

Two years of funding are available, with a negotiable start date of early fall 2019.

Responsibilities

We are seeking a postdoctoral fellow to work in developing novel statistical and epidemiologic methods for evaluating interventions in populations, in particular vaccines, in infectious diseases. Some of the research will focus on study designs for emerging infectious diseases, such as Zika, Ebola, pandemic influenza, and others. Some of the research will focus on other endemic or re-emerging infectious diseases, such as dengue, influenza, pertussis or rotavirus, but not HIV.

The postdoc may be expected to work with and develop state-of-the-art computational methods and phylogenetic techniques. 

Qualifications

To apply, please submit a single PDF document containing (1) cover letter including the names and contact information of three references (2) curriculum vitae (3) at least two representative papers.

Required qualifications:

• The postdoc needs to have a PhD or other doctoral level degree in statistics, biostatistics, computer science, quantitative epidemiology, or some related quantitative field, granted in the past five years
• Excellent communication skills, both verbal and written, are required

Preferred qualifications:

• Experience with applications in infectious diseases is desired
• Interest in learning or previous experience with phylodynamic methods is also desirable
• A knowledge and experience with methods of causal inference would be helpful
• A preference will be for individuals planning to develop their own independent research after the postdoc

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network (HVTN). Careers Start Here.

The HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.

SCOPE OF RESPONSIBILITIES
The HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines and other study products for safety and immunogenicity, to testing vaccine efficacy. The Protocol Development Manager (PDM) position provides a unique opportunity to work with leading world-class scientists and collaborators around the world and join the global team in discovering an effective HIV prevention vaccine.

The PDM manages the development of clinical trial protocols for HIV vaccines from concept to implementation, working with on-site and off-site protocol team members. The PDM establishes and maintains relationships, expectations, and collaborations, with team members with a wide range of expertise. The PDM may assist authors with the drafting and editing of concept sheets, concept proposals, and clinical protocols, including informed consent forms.

Responsibilities

• Direct development of clinical trial protocols for HIV vaccines and other investigational products from concept to implementation in conjunction with the Protocol Team Leader (PTL)
• Establish and maintain relationships, expectations, and responsibilities with stakeholders with varying expertise and interests including, principal investigators, vaccine developers, statisticians, NIH DAIDS medical officers, laboratory staff, pharmacists, regulatory affairs staff, clinical staff, and community education staff
• Manage development of documents and presentation materials for submission to funders, national regulatory entities, and other key audiences
• Construct clinical development plans, including timelines, milestones, and key decision points
• Contribute to the drafting and editing of protocols and related documents
• Coordinate HVTN program initiatives encompassing multiple clinical trials, funders, and institutional stakeholders as requested
• Organize and facilitate program stakeholder meetings
• Drive protocol development timelines; establish team meeting agendas and track ensuing action items in coordination with PTL
• Orchestrate submissions, reviews, responses to reviewer comments, and reviewer sign-offs of draft protocol documents from concept development through FDA submission
• Organize and facilitate protocol team two-day face-to-face meetings
• Support study conduct following implementation by collaborating with the data management and clinical trial Project Managers as needed
• Assemble and process protocol modifications and amendments following implementation
• Work on special projects that may include:
  • Scientific writing, literature and data reviews, and grant and manuscript development support
  • Compiling data and creating protocol and clinical development slides
  • Serve as a resource to colleagues within and outside of the US regarding protocol and protocol-related document development and control
  • Attend twice-yearly HVTN Meetings (out-of-state and out-of-country)

Qualifications

• Minimum of PhD in immunology, biology, or related field is required
• Knowledge of and experience with the conduct, research methods and regulatory aspects of clinical trials
• Excellent writing skills and scientific vocabulary capable of effective verbal and written communication with clinical research staff, health professionals, and clinical scientists required
• Demonstrated experience in managing multiple, deadline-driven complex projects simultaneously with minimal supervision required
• Experience working with large teams in a global network with off-site collaborators preferred
• High degree of organizational skills, effective time management, logical thinking, and close attention to detail
• Extensive MS Word experience; MS Project, SharePoint, Tableau, and Visio highly desired

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Lab Programmer II. Under general supervision of the Lab Programming Supervisor or Manager, the Lab Programmer provides programming support for Lab data management, reporting, and analysis needs of SCHARP. The Lab Programmer works in a team environment to support the overall mission of SCHARP. Core to the role is communicating effectively with team members and being responsive to the needs of various constituents inside and outside of the Division.

Responsibilities

The Lab Programmer will provide programming support for Lab Data Management services that include work with SCHARP analysis teams, external labs, and Network partners. Lab Data Management services focus on processing Assay and Specimen Data. The Lab Programmer will assist the team in building, maintaining, processing, and troubleshooting all aspects of our production assay data pipelines. The Lab programmer will also support and monitor specimen data reconciliation as well as take on team projects to improve team processes and code. Responsibilities may include:

• Gather and document requirements for developing or modifying existing programs and systems and defining file specifications for data transfer and necessary edit checks and transformations to meet user needs.
• Create, setup, test, and maintain Assay data pipelines for analysis.
• Create, setup, test, and maintain Specimen data reconciliation process.
• Work with SCHARP and external lab staff to resolve discrepancies between protocol expectations, case report form data, assay data, and specimen data.
• Test and de-bug programs and maintain version control on production programs and scripts.
• Create, test, document, and maintain SCHARP quality control checks.
• Create, test, document, and maintain ad hoc, standard, and study-specific reports.
• Support development of new or updates to work instructions (WIs) and standardization of processes (SOPs).
• Train external users on data upload procedures and data submission best practices.
• Ability to troubleshoot and resolve lab programming-related issues.
• Take initiative and lead team projects in best practices or process improvements.
• Apply best programming practices and collaborate with team members.
• Ability to work under pressure and juggle multiple projects.
• Perform other duties as required or assigned.

Qualifications

Required

• Bachelor’s degree in Computer Science or similar degree in a scientific, technical, or health-related field or additional programming training, skill, or experience.
• Two years’ experience in Python, SAS or any object-oriented programming language on Linux/Unix platform.
• Ability to work independently and communicate effectively as part of a project team.
• Ability to learn new programming skills as needed.
   

Preferred

• Basic SAS experience.
• Basic JavaScript experience.
• Basic Database Design and SQL experience.
• Basic SVN experience or any major source control application experience.
• Basic JIRA experience or any major ticket tracking application.
• Knowledge of and experience in programming support of clinical trials, statistical programming, or other scientific research programming support.
• Experience reading, parsing and transforming lab instrument data files programmatically.
• Experience reading, parsing and creating Excel files programmatically.
• Knowledge of laboratory procedures for assays, and work with laboratories to receive assay results.
• Understanding of computerized systems validation.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS and related infectious diseases. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The Laboratory Center is responsible for carrying out the scientific agenda of the HVTN by conducting laboratory-based studies to evaluate the immunogenicity of investigational vaccines.

Responsibilities

The focus of responsibilities for the QA Associate II is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing lab projects and programs for the HVTN Laboratory Operations Division. QA Associate I vs. II designation will be based on candidate’s qualifications and related experience.

The QA Associate will provide QA oversight to processing labs associated with HVTN clinical trials by:

• Providing oversight for domestic and international network site labs for HVTN study preparation: providing site training, developing and communicating study-related lab practices and operations, and determining network lab equipment needs. The QA Associate will monitor Good Clinical Laboratory Practice compliance, workload, and other key quality indicators that may impact deliverables.
• Providing input and support to other divisions within the HVTN and client protocol teams for specimen processing, storage and shipping, as well as clinical lab testing/methodologies.
• Facilitating implementation of specimen management programs for study related specimens including data entry and electronic systems support.
• Providing oversight for specimen processing and cryopreservation training and certification program.
• Providing peripheral blood mononuclear cell (PBMC) External Quality Control program support including analysis, interpretation and reporting to sites.  Review adequacy of site response on EQC reports.
• Create additional quality assurance programs for other specimen types.
• Collaborating with other divisions within the HVTN to support network clinical trials and representing the HVTN Lab Center in interactions with stakeholders.
• Providing network lab support and training through regular site visits, conference calls, or other appropriate media. Must be able to adapt communication styles based on targeted audience and topic.
• Assisting site labs with implementation of individualized Quality Assurance plans and related QA systems, such as local document control and equipment maintenance programs.
• Coordinating, participating in, and supporting the efforts of the HVTN Laboratory Program and performing additional activities as necessary.

Qualifications

Minimum qualifications

• B.A./B.S. in a medical science field
• Minimum 5 years of experience in clinical safety laboratory
• Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance
• Demonstrated experience in clinical safety laboratory management
• Ability to work with minimal supervision

Preferred qualifications

• At least 5 years of experience as a medical laboratory scientist or equivalent strongly preferred
• At least 1 year of laboratory experience focused in quality assurance
• Understanding of HIV diagnostics testing
• Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing and storage and clinical trials
• Computer skills – including Microsoft Word, Excel, PowerPoint and laboratory-specific programs
• Good numeracy, literacy and organizational skills
• Good interpersonal communication and time management skills
• Willingness to be flexible in working hours, be willing to travel as needed, and work some evenings and weekends
• Fluency in Spanish

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Research Administrator II is responsible for designing, developing, evaluating and interpreting financial information systems and budget/fiscal policies and procedures for faculty and management in Infectious Disease Sciences Program related to federal grant and contract management. The incumbent will perform complex technical fiscal analysis and financial reporting including planning and interpreting policies and regulations.

Under general direction, this position performs a variety of complex operating, capital budget or fiscal administrative support functions such as analyzing and developing budgets for grants, contracts, state funds, and program funds; assisting in the development of financial/fiscal policies; identifying project expenditure/revenue patterns; preparing analyses in support of program plans and budget requests; evaluating financial alternatives and recommending appropriate action; establishing and maintaining comprehensive fiscal record keeping systems; and recommending or implementing changes to fiscal information systems.

Responsibilities

Budget/Fiscal Support

• Develop, modify, and maintain multiple record keeping and reporting systems for varied and complex sources of funding; develop procedures for implementation, execution, control and review/audit of fiscal operations
• Develop, recommend, and/or establish expenditure forecasting for self-sustaining accounts; forecast fiscal needs/commitments; analyze policies and project fiscal impact
• Prepare budget projections, reconcile expenditures, and monitor the payroll changes.
• Analyze, modify and recommend improvements in subsidiary and general fiscal record keeping systems; apply knowledge of accounts and program relationships, data flow, audit trails and internal controls to design and implement financial data systems
• Select, develop, implement and/or modify manual or automated fiscal reporting/tracking processes to address specific unit needs

Funding Source Administration

• Work closely with Principal Investigators to develop budgets for grants, contracts, or other funding requests; prepare appropriate forms for contracts and agreements as needed.
• Coordinate and review all applications submitted for grant and contract funding.
• Secure the necessary signatures for grant and contract applications, and tracks approval process from beginning to submission to ensure that all the necessary permissions are documented prior to the grant/contract deadline.
• Consult with funding agencies to resolve problems and/or obtain approval for deviation from authorized procedures or expenditures; advise and assist organization's staff regarding budgetary policies and procedures, account status
• Anticipate, coordinates and plans for all competing and non-competing reports/submissions. 

Regulatory Support

• Manage renewal timelines and ensure completion of regulatory documents in conjunction with IRB team for competing and non-competing reports/submissions.
• Identify necessary regulatory components of submissions, confirm with IRB team that required items are in place and escalate issues as needed.
• Determine impact of and develop implementation plans with IRB team in response to applicable regulatory changes and/or revisions to Center policies and procedures
• May serve as a central point of contact to answer questions, escalating issues as needed.

Administrative Support

• Complete or delegate key administrative tasks such as travel coordination, editing CVs and publications, purchasing and maintenance of supplies and equipment
• Identify administrative issues for discussion with leadership
• Assist with the development of lower level staff
• May manage projects including occasional event planning and management
• May assist in the training and development of team members

Leadership

• May act as a resource for lower level staff

Clinical Trials Addendum

• Manage budget based on protocol (Core)
• Set up and pay bills to third parties (Core)
• Ensure regulatory documents are in place (CT)
• Responsible for Clinical Trials Billing including the creation of payment invoices.  
• Tracking and Auditing of procedures to ensure compliance (CT)
• Amend budget through the life of a study (Core)
• Attend study implementation meetings as needed (CT)
• Manage multi-site components (sub-awards) (Core)

Qualifications

• Bachelor's degree in Accounting, Public Administration, or related field
• At least 2 years of work experience building, overseeing, and managing budgets
• Excellent written and verbal communication skills
• Strong computer skills—MS Word, Access, Adobe Acrobat and advanced knowledge of Excel required.
• Demonstrated ability to multi-task in a fast-paced fiscal management environment
• Ability to adjust work-hours to meet grant deadlines, as needed
• Demonstrated ability to work effectively in a team environment as well as individually
• Ability to problem-solve and process information quickly with a high attention to detail
• Previous work experience in grants and contracts field is preferred

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Biostatistics, Bioinformatics and Epidemiology (BBE) at Fred Hutch is seeking a Research Administrator IV. The Research Administrator IV will work independently and collaboratively to coordinate grant/contract proposals and renewal submissions; monitor project budgets; advise Principal Investigator(s) and Associate Director(s) of the current budget status and projections; and interact with Center personnel and external organizations regarding fiscal aspects of the projects/program.

Responsibilities

This is a multi-faceted position with a range of fiscal responsibilities. The individual in this position must be able to work independently and prioritize tasks to meet grant/contract submission and reporting deadlines for a very active research portfolio. This individual will manage the day-to-day grant/contract operations associated with a large DAIDS (Division of AIDS) Network Grant, or equivalent, within the Biostatistics, Bioinformatics, & Epidemiology program in the Vaccine and Infectious Disease Division. This includes but is not limited to monthly reconciliation and financial reporting; developing, modifying, and maintaining shadow-books and ad-hoc reports using complex excel formula heavy tools; resolve issues as needed for the timely conveyance of funds; and act in an advisory capacity for Principal Investigators. The person will perform complex fiscal analyses and financial reporting, including strategic planning, problem solving, interpreting, reviewing and providing recommendations.

Pre-Award Activity:

• Work closely with Principal Investigators and other Faculty to prepare and submit grant and contract applications to funding agencies, ensuring all forms are completed correctly, all content is included, and the application receipt deadline is met
• Advise faculty members as they navigate the grant proposal process. Understands all parts of the application process and the different requirements of various funding sources. Interpret Request for Applications (RFAs), create and communicate timelines, complete non-technical/non-scientific portions of the submissions, and oversee institutional signoff.
• With input from the Principal Investigator, develop the budget and related financial portions of the application. This may include international and domestic subawards, and life of study clinical trials. Ensures that content is accurate, complete, and in compliance with the governing regulations.
• Offer editing and formatting assistance with proposals, ensuring sponsor requirements are met. Review all sections for consistency of terms, clarity of writing, and response to application instructions.
• Understand and has a facility with the range of forms that Fred Hutch and the various funding agencies require
• Secure the necessary signatures for grant and contract applications, and tracks the approval process to insure that all necessary permissions are documented prior to the grant/contract deadline for submission
• Identify sources for additional funding, supplements, and plan for all competing and non-competing reports

Post-Award Activity:

• Responsible for post-award oversight by reviewing and interpreting notice of award, create booking budgets, active management of commitments and budgets, prepare short and long term budget forecasts, and ad-hoc reports. Collaborate closely with the Principal Investigators, Leadership, and SCHARP (Statistical Center for HIV/AIDS Research and Prevention) Senior Project Managers.
• Initiate, review, and monitor subawards/subcontracts for spending and compliance
• Use appropriate tools of the Finance section to document the chronology of grant/contract preparation and administration in order to keep colleagues and supervisor informed of the most current status. Maintain grant/subcontract files in electronic format.
• Works directly with Fred Hutch Office of Sponsored Research staff to resolve questions and issues related to grants and contracts, including closeout, cost transfers, supplement requests, carry-forwards, funder invoice backup requirements, interim reporting, re-budgeting, and no cost extensions
• Assist with expense approval and invoice processing, assuring that charges are appropriate, invoices are paid in a timely manner, and charges are allocated to the correct budget
• Assist in the preparation and monitoring of Institutional Review Board (IRB) documentation, particularly as it relates to grants management
• Understands the policies and procedures of the NIH and other funding agencies in significant detail and tracks changes to those policies and procedures on a timely basis
• Participates as an active contributor in meetings. Serve as a divisional and/or program representative as needed.

Qualifications

Required:

• BA in Accounting, Finance, Public Administration, or related field or equivalent experience
• Five years in pre-award and post-award grant and contract management
• Knowledge of relevant regulatory requirements affecting sponsored research, and ability to apply this knowledge
• Effective and professional oral and written communication skills, with the ability to tailor communications to specific audiences
• Ability to navigate complex internal systems and departments while exercising sound judgement and discretion
• Proficient with complex budget development and use of reporting tools
• Advanced skills in Word, Adobe Acrobat Pro, and Outlook
• Advanced skills in Excel including familiarity with pivot tables
• Excellent time management and prioritization skills, with the ability to effectively manage multiple and competing demands
• Demonstrated ability to function independently while exercising skill and informed professional judgment
• Highly organized and detail oriented
• Demonstrated ability to work successfully as part of a diverse team

Preferred:

• Experience with National Institute of Health (NIH) awards, namely Cooperative Agreements

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

This research opportunity is with the McElrath Lab within the Vaccine & Infectious Disease Division. The technician will work under the direction of a Staff Scientist and use discretion and judgment in performance of duties in support of human mucosal immunology studies relevant to HIV-1 prevention. In particular, they will perform and assist in the development of mucosal explant models for evaluating the functionality, levels and distribution of HIV-1 specific antibodies. They will also be responsible for processing various mucosal specimens from study participants, performing downstream assays, collecting and analyzing the data.

The incumbent will work closely with other laboratory staff conducting mucosal studies. They will interpret and report on experimental results and assist with data presentation for conferences and manuscripts. They may work with the clinical staff from the Fred Hutch HIV vaccine Trials Unit, University of Washington Medical Center (UWMC) and other hospitals to coordinate specimen transfer and/or personally pick up specimens. They will assist in the development and maintenance of laboratory quality control (QC) methods and records, which may require adherence to GCLP (Good Clinical Lab Practice) standards

***A cover letter is required for consideration for this position***

Responsibilities

• Coordinate specimen collection and transport from UWMC and other clinics
• Coordinate sample shipping/receiving with collaborating laboratories
• Process cervicovaginal, rectal and other mucosal tissue specimens
• Process cervicovaginal secretions, rectal secretion and seminal plasma
• Be available to process additional mucosal specimens as needed (e.g. cervical cytobrushes)
• Perform ex vivo infectivity assays on mucosal tissues
• Perform luminescence reporter assays to measure HIV infection
• Prepare single cell suspension from mucosal specimens, such as cytobrushes and mucosal tissues
• May prepare and cryopreserve PBMC
• Perform microdissection of mucosal tissue to separate epithelium from underlying stroma
• Perform and assist in developing immunohistochemistry assays on mucosal tissues
• May perform confocal microscopy, including receptor and virus co-localization in mucosal tissue
• Perform and assist in developing flow cytometric assays (e.g. both phenotyping and functional assays)
• Perform and assist in developing ELISAs and related assays to measure mucosal analytes (e.g. mucosal antibodies)
• Perform and/or help optimize new assays and specimen processing methods as needed
• May perform and help optimize qPCR and/or digital droplet PCR assay (e.g. for detecting HIV-1 infection)
• May prepare stocks of HIV isolates by transient transfection
• Maintain records for experiments and quality control for the laboratory
• Operate and carry out proper maintenance and QC of laboratory equipment
• Prepare and maintain reagents, stocks, and cultures necessary to perform work
• Order and maintain laboratory supplies
• Other duties as assigned

Qualifications

A bachelor’s degree in a biological science and some bench research experience or the equivalent combination of education and experience. Experience with cellular immunologic assays, tissue culture, micro-dissection, molecular biology and microscopy is desirable but not essential. Motivation and adaptability are essential, as is a keen interest in the HIV vaccine and prevention fields. Must be willing to work with biohazardous/infectious agents (e.g., blood-borne pathogens, including HIV-1), including human tissues under carefully controlled conditions. Strong organizational and communication skills are necessary. Must be flexible and willing to work some evenings and weekends.

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. The Center’s five scientific divisions collaborate to form a unique environment for conducting basic and applied science. Vaccine and Infectious Diseases Division (VIDD) works to eliminate or minimize the impact of globally significant infectious diseases. Within VIDD is the Statistical Center for HIV/AIDS Research & Prevention (SCHARP), which provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Programmer III.

With guidance, the Senior Statistical Programmer provides statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, re-usable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses SAS; additional statistical and analytical software programs are used as needed. Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect. The Senior Statistical Programmer shows independence in management of workload and production of quality output, as well as technical expertise that contributes to the programmatic infrastructure of the Statistical Programming group.

Responsibilities

Responsibilities will include a subset of the following, based on network(s) supported:

• Gather and document requirements for developing or modifying existing programs and systems
• Define and edit mock tables, listings and figures (TLFs) and analysis dataset specifications
• Generate, document, and maintain analysis datasets
• Create ad hoc, standard and study-specific reports (e.g. SMC, DSMB, SMB); may perform cross-study reporting
• Test and de-bug programs and maintain version control on production programs and scripts
• Design and develop new work instructions (WIs) and updates to existing
• May coordinate efforts to standardize WIs or processes across studies
• Develop and maintain automation of routine analysis data and reporting tasks
• Contribute to good programming practices, and cross-group programming initiatives and code libraries
• Work with clinical programmers, labs, statisticians, and other statistical programmers to resolve data quality, processing, and analysis issues
• Contribute to mentoring and training of junior Statistical Programmers and may supervise as needed

Qualifications

Required

• Bachelor’s degree in Computer Science or a scientific, technical, or health-related field
• At least four years of experience as a SAS programmer on PC/Unix platform; Preferred experience programming in support of clinical trials, statistical programming in a clinical research setting or other health research programming support
• Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
• Demonstrated ability to multi-task and appropriately prioritize work assignments
• Knowledge of and experience with clinical trials research data
• Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting
• Advanced SAS programming skills
• Strong reporting and SAS macro development abilities
• Knowledge of SAS (including graphics experience) and other programming languages
• Ability to use Perl or other scripting languages for text manipulation and automated job control

Preferred

• Graduate degree in computer science or a scientific, technical, or health-related field
• Knowledge of CDISC standards (SDTM and ADaM)
• Experience using version control tools

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

We seek a Senior Project Manager with strong clinical research knowledge/background, audit coordination and facilitation skills, and the ability to manage multiple projects for the Infectious Disease Sciences' clinical trials/clinical research compliance activities. This individual reports to the Program Operations Director of the Infectious Disease Sciences (IDS) Program, oversees IRB/Regulatory processes and activities in IDS and serves to enhance our compliance activities in order to support the overall development and growth of the IDS Program’s clinical research contracts and clinical trials.

The role will help drive projects and bring value through activities including research of applicable rules and procedures, managing and monitoring quality systems within the Program, and maintaining a current working knowledge of applicable regulations and standards. The ideal candidate will be responsible for managing the program’s IRB/Regulatory team, developing a deep understanding of Good Clinical Practices, Human Subjects, FDA and NIH processes, reviewing and updating standard operating procedures, coordinating systems audits and audit follow-up, facilitating external inspections and study visits, and monitoring contract milestones and customer service issues.

For more information about the work of Infectious Disease Science, click here: 

https://www.fredhutch.org/en/research/divisions/vaccine-infectious-disease-division/research/infectious-disease-sciences.html

Responsibilities

Compliance, Audits and IRB/Regulatory Team Management and Oversight

• Manage Program’s IRB/Regulatory staff by facilitating and supporting regulatory, human research protection and related activities in a dynamic clinical research environment, and by enhancing and applying knowledge of regulatory guidelines (IB, IACUC, MUA, etc.), and knowledge of FDA, GCP and NIH requirements.
• Be the primary Program lead for Fred Hutch’s CTMS systems.
• In conjunction and support of the Fiscal team, the various clinical research teams and study PIs, conduct contract reviews and assessments of collaborative and sponsorship activities, work products, and deliverables that includes identification of potential risks and recommendations for mitigation.
• Help to ensure laboratory and research services are in compliance with study protocols and approved SOPs.
• Be responsible for internal audits and be the primary contact for sponsor and regulatory agency audits. Lead, prepare and participate in on-site regulatory audits and inspections.
• Prepare written records of all inspections and audits, including protocol/plan, and SOPs.
• Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations as well as basic understanding of the requirements and systems of the FDA, other government agencies, and sponsorship organizations.

Clinical trials liaison, contract negotiation and implementation

• Be the primary Program lead in clinical trials/clinical research contract negotiations.
• Assist in tracking and managing all contracts through the contract lifecycle, including drafts, modifications, executions, amendments and renewals. Prepare contract briefs to assure proper interpretation of the contract.
• Manage selected VALUE contracts and assist with close-outs. Disseminate contractual information as appropriate.
• Facilitate responses to cost/pricing bids for selected clinical trial studies, proposals and contract negotiations including doing initial reviews of contract terms and requirements, to ensure compliance with all laws and regulations and policies and procedures.
• Audit existing contracts and oversee contract modifications.
• Coordinate with Business Development and PI teams to provide strategic input on contracting opportunities and assist in the development, population, and maintenance of an in-house contract management system.

Team Support, Communications, Record-keeping

• Provide staff supervision to the IRB/Regulatory functional team of the IDS Program by planning and overseeing their training, performance, assignment of work and professional development to advance the Program’s regulatory operations.
• Contribute to a positive and productive work environment through effective collaboration with cross functional units.
• Proactively develop relationships with, establish goals in collaboration with and have regular touchpoints with key internal stakeholders including clinical, research and business development, Program and PI teams.
• Work with clinical research study teams, fiscal and lead regulatory staff to ensure timely delivery of contract administration milestones.
• Develop and support established records management procedures.
• Assist in the development, maintenance and monitoring of program reports, key performance indicators, forms and templates.
• Effectively communicate with contracted agencies, partners and stakeholders.

Project Management, Process Improvement

• Organize and promote Program-wide quality system improvement efforts.
• Update and review standard operating procedures, work instructions, forms and templates as required.
• Participate in process improvement activities including assessing current processes, providing improvement input and implementing changes.
• Work closely with clinical research teams to provide expert compliance and regulatory information, manage identified issues, and support continuous improvement.
• Manage other related projects as assigned by Program Operations Director.

Qualifications

Required

• Bachelor’s Degree;
• 5+ years of related experience in human subjects research, contract management/auditing, clinical trial management, project management and/or quality compliance role in the pharmaceutical/biotechnical industry or medical research environment strongly desired.
• Extensive experience interpreting federal regulations, applying sponsor guidelines, policies and practices and complex sponsor requirements and recommending actions and resolving complex issues.
• Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical
• Familiarity with basic contract law and standard legal forms and analytical reasoning desired.
• Self-starter with excellent verbal, written, presentation, and interpersonal communication skills and ability to work with internal and external sources to understand what action is needed to obtain all required documentation.
• Proven interpersonal skills with the ability to work collaboratively as a member of cross-functional teams, and ability to establish and maintain effective working relationships.
• Proficiency with designing tools and working with electronic systems used to manage clinical trial data or safety reporting.
• Must have mature and professional communications skills, strong independent time management skills and the ability to multi-task.
• Demonstrated ability to maintain confidentiality.

Preferred

• Master’s Degree in health care related field
• Working knowledge of regulatory guidelines and expertise in quality for the advancement of therapeutics through different phases of development.
• Clinical research and compliance, PM certification

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Senior Lab Programmer. Under minimal supervision of the Lab Programming Supervisor or Manager, the Senior Lab Programmer provides programming support for Lab data management, reporting, and analysis needs of SCHARP. The Senior Lab Programmer works on complex assignments in a team environment to support the overall mission of SCHARP. Core to the role is communicating effectively with team members and being responsive to the needs of various constituents inside and outside of the Division.

Responsibilities

The Senior Lab Programmer will provide programming support for Lab Data Management services that include work with SCHARP analysis teams, external labs, and Network partners. Lab Data Management services focus on processing Assay and Specimen Data. The Senior Lab Programmer will lead the team in building, maintaining, processing, and troubleshooting all aspects of our production assay data pipelines. The Senior Lab programmer will also support and monitor specimen data reconciliation. Within the Lab Programming team, responsibilities include leading complex projects that work across SCHARP teams, lead team projects to improve team processes and code, and mentor less experienced team members.

Responsibilities may include:

• Gather and document requirements for developing or modifying existing programs and systems and defining file specifications for data transfer and necessary edit checks and transformations to meet user needs
• Create, setup, test and maintain Assay data pipelines for analysis
• Create, setup, test, and maintain Specimen data reconciliation process
• Work with SCHARP and external lab staff to resolve discrepancies between protocol expectations, case report form data, assay data, and specimen data
• Create, update, test, and de-bug programs and maintain version control on production programs and scripts
• Create, test, document, and maintain SCHARP quality control checks
• Create, test, document, and maintain ad hoc, standard and study-specific reports
• Lead development of new or updates to work instructions (WIs) and standardization of processes (SOPs)
• Train external users on data upload procedures and data submission best practices
• Ability to troubleshoot and resolve lab programming-related issues
• Take initiative and lead complex, multi-SCHARP team projects
• Lead team projects in best practices or process improvement
• Help mentor and advise less experienced team members
• Apply best programming practices and collaborate with team members
• Ability to work under pressure and juggle multiple projects
• Perform other duties as required or assigned

Qualifications

Required

• Bachelor’s degree in Computer Science or similar degree in a scientific, technical, or health-related field or additional programming training, skill, or experience.
• 4+ years of experience in Python, SAS or any object-oriented programming language on Linux/Unix platform.
• Ability to work independently and communicate effectively as part of a project team.
• Ability to learn new programming skills as needed.

Preferred

• 5+ years of experience in Python, SAS or any object-oriented programming language on Linux/Unix platform.
• 1+ year of experience in Database Design and SQL
• Basic SAS experience
• Basic JavaScript experience
• Basic Perl experience
• Programming experience in multiple languages in a scientific or health related field
• Basic SVN experience or any major source control application
• Basic JIRA experience or any major ticket tracking application
• Knowledge of and experience in programming support of clinical trials, statistical programming, or other scientific research programming support
• Experience reading, parsing and transforming lab instrument data files programmatically
• Experience reading, parsing and creating Excel files programmatically
• Knowledge of laboratory procedures for assays, and work with laboratories to receive assay results
• Understanding of computerized systems validation

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Senior Statistical Programmer. Under minimal supervisions, the Senior Statistical Programmer provides statistical programming expertise within SCHARP by coordinating with statisticians to write efficient, reusable, and easily maintainable code that access, analyze and report data descriptives and analyses. The incumbent primarily uses SAS and R; additional statistical and analytical software programs are used as needed. Core to the role is the ability to communicate effectively, work collaboratively with colleagues and be responsive to the needs of both internal and external customers within an environment of mutual cooperation and respect. The Senior Statistical Programmer works on complex assignments, shows independence in management of workload and production of quality output, as well as technical expertise that contributes to the programmatic infrastructure of the Statistical Programming group. The Senior Statistical Programmer may also mentor and/or supervise a junior statistical programmer.

Responsibilities

Responsibilities may include:

• Gather and document requirements for developing or modifying existing programs and systems
• Define and edit mock tables, listings and figures (TLFs) and analysis dataset specifications
• Generate, document, and maintain analysis datasets
• Create ad hoc, standard and study-specific reports (e.g. SMC, DSMB, SMB); may perform cross-study reporting
• Test and de-bug programs and maintain version control on production programs and scripts
• Design and develop new work instructions (WIs) and updates to existing WIs.
• May coordinate efforts to standardize WIs or processes across studies
• Develop and maintain automation of routine analysis data and reporting tasks
• Contribute to mentoring and training of junior Statistical Programmers as needed

Qualifications

Required

• Bachelor’s degree in computer science or a scientific, technical, or health-related field
• At least five years of experience in SAS or R programming, with additional experience in other programming languages including a scripting language
• At least two years of experience in support of clinical trials, in a clinical research setting or other health research setting;
• Demonstrated ability to communicate effectively in a matrix management environment as a member of several project teams
• Demonstrated ability to multi-task and appropriately prioritize work assignments
• Knowledge of and experience with clinical trials research data
• Knowledge of and experience with biostatistics or statistical analyses in a clinical trials setting
• Knowledge of R (graphics experience) and other programming languages
• Strong SAS reporting and macro development abilities
• Advanced SAS programming skills
• Ability to use Perl or other scripting languages for text manipulation and automated job control

Preferred

• Graduate degree in computer science or a scientific, technical, or health-related field
• 5+ years of statistical programming in a clinical research setting.
• Knowledge of CDISC standardization practices
• Knowledge of laboratory data

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Software Developer with professional experience to add to our development team.

Responsibilities

• Implement and maintain systems within a validated software development lifecycle 
• Participate in agile requirements gathering, design and tasking 
• Provide operational support for existing systems 
• Work on a project team with customers, business analysts, project management and testers 
• Work on a development team creating and following standards that help with cross training and reducing system maintenance tails 

Qualifications

Minimum: 

• 3-6 years professional experience in software development 
• Expertise with modern OOP programming paradigms / languages 
• Experience with relational data modeling: conceptual and physical 
• Defining and writing automated unit and functional tests 
• Detail oriented including the following:  
  • Ability to understand a system of complex interactions 
  • Capable of deep troubleshooting and discovering root causes of problems 
  • Writes unit tests with the same care as product code 
  • Has well-commented code

Preferred: 

• Java full stack web application development experience, both front-end and back-end 
• Agile development 
• UNIX systems 
• PostgreSQL 
• Javascript, Selenium 
• Play Framework 
• Microservice architecture 
• Docker, Kubernetes, AWS 
• Functional programming 
• Working in a regulated environment such as 21 CFR Part 11, Sarbanes-Oxley or HIPPA 

Culture: 

• Work in an organization that strives to make the world a better place.  
• Work with developers who enjoy crafting quality code and robust performant systems.  
• Work in vibrant South Lake Union Seattle.  
• Strong commitment from management to a 40 hour work week.  
• Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan. 

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Software Developer with professional experience to add to our development team.

Responsibilities

• Implement and maintain systems within a validated software development lifecycle 
• Participate in agile requirements gathering, design and tasking 
• Provide operational support for existing systems 
• Work on a project team with customers, business analysts, project management and testers 
• Work on a development team creating and following standards that help with cross training and reducing system maintenance tails 

Qualifications

Minimum: 

• 3-6 years professional experience in software development 
• Expertise with modern OOP programming paradigms / languages 
• Experience with relational data modeling: conceptual and physical 
• Defining and writing automated unit and functional tests 
• Detail oriented including the following:  
  • Ability to understand a system of complex interactions 
  • Capable of deep troubleshooting and discovering root causes of problems 
  • Writes unit tests with the same care as product code 
  • Has well-commented code

Preferred: 

• Java full stack web application development experience, both front-end and back-end 
• Agile development 
• UNIX systems 
• PostgreSQL 
• Javascript, Selenium 
• Play Framework 
• Microservice architecture 
• Docker, Kubernetes, AWS 
• Functional programming 
• Working in a regulated environment such as 21 CFR Part 11, Sarbanes-Oxley or HIPPA 

Culture: 

• Work in an organization that strives to make the world a better place.  
• Work with developers who enjoy crafting quality code and robust performant systems.  
• Work in vibrant South Lake Union Seattle.  
• Strong commitment from management to a 40 hour work week.  
• Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan. 

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Work in an organization that aims to make the world a better place and is home to three Nobel Prize winners. Enjoy an awesome work-life balance with a strong dedication from management to a 40 hour work week, support for public transit / bike commuting, healthy eating options in the Hutch's cafes and an office across from the water in South Lake Union. Benefits include paid vacation, holidays, sick time, medical, dental and vision benefits as well as 403 (b) retirement plan.

The Gottardo Lab is a Research Lab within the Computational Biology program at the Fred Hutchinson Cancer Research Center. We develop statistical methods and computational tools for managing and analyzing high-throughput biological data including single-cell RNA-seq, flow-cytometry, CyTOF and CITE-seq, to name a few. We then utilize these tools, in collaboration with immunologists and clinicians, to analyze high-dimensional data from pre-clinical and clinical trials in an effort to accelerate the development of new cancer immunotherapies and vaccines. Our lab participates in large collaborative efforts funded by the NIH, Gates Foundation and the CZI including the Human Immunology Project Consortium, the Human Cell Atlas, the Cancer Immunotherapy Trial Network and the Collaboration for Aids Vaccine Discovery.

As a lab, we value inclusion and a diversity of backgrounds and perspectives to inform our work. We believe in supporting each other through mentorship and providing resources for professional development. Given these values, we strive to make our recruitment and promotion processes fair and transparent. Therefore, we strongly encourage all individuals with an interest in the position to apply. To learn more about our lab, go to rglab.org.

The Gottardo Lab is seeking a PhD level computational biologist to fill a Staff Scientist position to help support large collaborative projects in computational immunology with applications to cancer immunotherapy and vaccine development. The Staff Scientist will have the opportunity be involved in the development of cutting-edge technologies and associated tools for profiling immune responses in blood and tissues at a single-cell resolution and in the application of these tools in innovative pre-clinical and clinical studies. The incumbent will participate in multidisciplinary collaborations involving laboratory-based scientists (immunologists, cancer researchers), clinical investigators, biostatisticians, data scientists, programmers and computational biologists.

Responsibilities

• Develop and optimize computational pipelines to enable the integration and management of large and complex data sets
• Develop well-documented, properly tested, open-source software for reproducible research
• Interpret results from computational and statistical analysis
• Assist with study design of pre-clinical and clinical trials
• Participate in the dissemination of research findings
• Co-author manuscripts for publication
• Assist supervision of team members in the Gottardo Lab (postdocs, junior computational biologists)
• Manage and set scientific priorities across projects

Qualifications

Minimum Qualifications:

• PhD or equivalent degree in bioinformatics, computational biology, biostatistics, statistics, computer science, or a related field.
• Experience in analysis of next generation sequencing data
• Excellent programming skills (python, R, C/C++, Java) including best software development practices (e.g. design, unit tests, documentation, code review)
• Excellent interpersonal, oral and written communication skills
• Strong work ethic
• Ability to work in a team, and supervise junior team members
• Ability to manage multiple projects and to meet deadlines

Preferred Qualifications:

• Understanding of immunology and/or immunotherapy
• Experience in single-cell analysis

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Technical Project Manager II. Responsible for overall planning, resource coordination, scheduling, and execution of various technology-related projects. Ensures projects are delivered within the planned schedule and scope.

Responsibilities

The Technical Project Manager II is responsible for managing medium, moderately complex projects with teams of up to 8 people that involve up to 2 technologies within a single organizational unit. The Technical Project Manager II reports to the Associate Director, SCHARP TSS.

Responsibilities include:

• Work with project sponsors and stakeholders to define project requirements, scope, risks, organization, and approach.
• Manage the creation of project plans, process and data flow diagrams, use case examples, user interaction wireframes, user workflows, conceptual data models, implementation timelines and testing plans.
• Work with resource managers to obtain resources. Track and manage issues and risks.
• Manage project and sprint backlogs in accordance with agile methodology (create project/sprint backlogs, plan and manage sprints, and coordinate stakeholder review).
• Provide leadership and direction to the project team, in alignment with SCHARP’s SDLC, to successful completion of assigned project tasks.
• Build and maintain strong working relationships with team members, project sponsors and peers. Communicate status to project sponsors, team, and stakeholders.
• Manage scope, schedule, and resource changes according to defined change control procedures.
• Serve as project liaison, representing the project to other center departments, affiliated individuals or institutions, and outside organizations.
• Manage vendor/consultant resources as required by project.
• Applies technical experience and knowledge in support of business and technology goals.
• Provides leadership in development of organizational best practices for project management and SDLC.

Qualifications

Minimum Qualifications

• Bachelor’s degree.
• A minimum of 4 years of project management with 2 years experience managing medium to complex technology projects.
• Experience managing multiple technology projects for the full life cycle utilizing a System Development Life Cycle methodology.
• Experience with agile methodologies such as Scrum.
• Requires excellent written and verbal communication skills and demonstrated ability to work independently, lead projects and to manage competing priorities in a fast-paced environment.
• Proven ability to understand technical details and systems architecture, and to translate and communicate between technical teams and stakeholders.

Preferred Qualifications

• Bachelor’s degree in Computer Science or similar degree in a scientific or technical field.  Agile Certified Practitioner (PMI-ACP) or Scrum Master certification.
• Project Management Proficiency (PMI-PMP) certification.
• Experience as a software developer.
• Experience working in a regulated environment and applying regulations such as 21 CFR Part 11 to IT projects.
• Experience conducting Computer System Validation, as defined by the FDA, as part of a Systems Development Life Cycle.