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 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.

The Administrative Manager, Faculty Affairs and Communications will be responsible for managing academic faculty and scientific staff appointments and promotions, and related faculty affairs for the Vaccine and Infectious Disease Division (VIDD), Fred Hutch.  In conjunction with VIDD and Fred Hutch Leadership, this position will coordinate external faculty searches, appointment processes for faculty, quarterly faculty meetings and assist with faculty reviews.  This position will also steward faculty promotions, including scientific staff appointments and promotions, in cooperation with related faculty affairs staff at University of Washington for those concurrent appointments and promotion processes for all VIDD faculty with joint appointments.  Concurrently, this position will be responsible for the overall internal and external communications and marketing plan for VIDD, including the development and maintenance of content for divisional websites, the creation of various communication materials, and management of communications schedules and projects. The position will also serve as the main point of contact for VIDD communications to external departments. This position reports directly to the Sr. Director of Faculty Affairs and Sr. Operations Director.

Responsibilities

Faculty Affairs (60%)

• Serve as expert on interpretation of faculty guidelines for the Division as well as rules, policies, and procedures consistent with Fred Hutch policies and in collaboration with other Fred Hutch departments and partners
• Plan and manage the annual, midterm, and 5-year faculty reviews according to review calendar and timelines in partnership with Senior Director of Faculty Affairs and Strategic Initiatives. Provide direction to faculty for preparation of required materials.
• Administer faculty promotions. Advise and support promotion committees; manage review process from initiation to final approval; provide direction to candidate on required materials; serve as liaison to other division(s) and the University of Washington, where applicable.
• Support VIDD A&P Committee, Faculty Advisory Committee, Promotion and Review Committees. Work with leadership to develop monthly agenda, document meetings, and follow up on action items.
• Coordinate faculty recruitment process. Train staff to support faculty recruitment process, advise and support search committees, interact with HR on advertisement placements logistics; manage applicant materials; plan candidate visits as applicable; monitor recruitment committee activities and follow up on needed actions.
• Serve as VIDD liaison to Research Administration and Faculty Affairs office to ensure faculty appointment, promotion and review processes are on track and faculty CVs are current in relation to Research Administration and Faculty Affairs guidelines
• Develop and implement strategies to ensure that diversity, equity and inclusion are actively incorporated into all faculty guidelines, rules, policies and procedures
• Lead the project management and implementation of strategies to streamline processes and document management for VIDD FAO
• Create, maintain and distribute information on standard operating procedures for VIDD FAO

Communications (40%)

• Serve as a liaison to the Center Marketing and Communications team and VIDD point of contact for Center-wide communications projects
• Provide guidance to content authors within VIDD on branding guidelines as the primary administrator for the Division CenterNet (intranet) site
• Oversee the maintenance and creation of content for VIDD extranet and intranet sites
• Drive integrated communications efforts and establish a comprehensive communications plan and calendar to manage the cadence of information distribution and enhance existing communications channels
• Collect content, design, and distribute the VIDD monthly newsletter; generate reports on newsletter performance as needed
• Steward new communication efforts and channels including training where necessary to help VIDD to be a leader in social media; execute a division-level social media strategy and approach by creating content, monitoring and managing communications activities.
• Plan and execute strategies for adding new content, initiating new communications projects and increasing engagement among target audiences
• Design promotional and presentation material to support VIDD events, programs and initiatives
• Coordinate and manage data visualization projects, distribution of data, and strategies to design strategic dashboards and visualizations to support VIDD in partnership with the Senior Operations Director, VIDD

Qualifications

Minimum qualifications:

• BA/BS required
• Minimum of 3 years of administrative management experience in a research or academic setting
• Excellent written and verbal communication skills
• Experience working with faculty and academic affairs issues a plus
• A cover letter is required 

Professional Skills/Attributes:

• Strong interpersonal, customer service and communication skills
• Maintain a high level of confidentiality, sound judgement and superior attention to detail
• Manage multiple tasks within a fast-paced environment while operating under strict time constraints
• Impeccable record keeping, filing and organizational skills
• Ability to interact diplomatically and effectively with various stakeholders
• Ability to follow policies and procedures
• Highly developed communication skills
• Good sense of humor and team player

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 Seattle Vaccine Trials Unit (VTU) (click here to visit their webpage) is a program within the Vaccine & Infectious Disease Division of Fred Hutchinson Cancer Research Center. Led by Principal Investigator Julie McElrath, the VTU is funded to conduct phase I, II, and III clinical trials. As a clinical research site, the VTU is responsible for the recruitment, selection, and enrollment of study participants, and immunization and clinical monitoring of these participants in clinical trials of investigational agents being studied for the prevention of HIV, SARS-CoV-2, and other infectious diseases. 
  
The Clinical Research Nurse Practitioner, coordinates, and implements clinical research studies involving human subjects for the Immunology & Vaccine Development research program. The primary focus of the Clinical Research Nurse is screening, enrolling, and following study participants. The position will require willingness to work with COVID-19 and HIV prevention modalities (vaccines, immunoprophylaxis, etc.) as well as working in settings where individuals with active COVID-19 infection will be seen. This position will likely work at the unit’s remote and mobile sites, so flexibility in travel and hours will be important. 

Responsibilities

The incumbent works under the supervision of the Principal Investigator as part of a clinical research team including the VTU physicians, other clinicians, and other unit personnel. Direct supervision will be by the remote/mobile unit’s supervising clinician. The position requires the performance of responsibilities with a high level of independence within the scope of study protocol(s) and guidelines. 

• Determine participant study eligibility, obtain informed consent, and initiate participant randomization and enrollment in research studies in accordance with regulatory and GCP guidelines and institutional policy including:
  • Provide a complete explanation of a study to potential volunteers so as to obtain informed consent
  • Conduct phone (or other remote) visits for protocols involving off-site screening, enrollment, and electronic consenting
  • Record and evaluate medical histories as well social and sexual histories (if required by protocol)
  • Draw blood for screening labs if required per protocol, and interpret the results for inclusion/exclusion criteria, as well as for medical follow-up if needed
  • Provide pregnancy prevention counseling for women, including contraceptive counseling as needed
  • Perform complete physical exams and complete other physical exam assessments per protocol requirements
• Follow study protocol for each participant visit
• Perform clinical procedures including vital signs, vaccine administration, blood draws, IV infusions, and physical exam assessments
• Able to perform, or willing to learn skills to perform, mucosal biopsy procedures including collection of vaginal, cervical, and rectal biopsy samples
• Maintain appropriate source documentation and complete case report forms/electronic case report forms
• Identify, assess, and report adverse events in accordance with protocol and regulatory guidelines and institutional policy
• Provide various forms of health education to study participants and provide appropriate referrals to community medical, social, substance abuse and mental health programs if needed.
• Help to maintain the compliance of participants with protocol visit schedule
• Provide support for community education and recruitment with the VTU community educator, recruitment coordinator, and recruiters
• Assist the clinic coordinator and/or the supervising clinician in managing the daily operations of a research study
• Assist the clinic coordinator and/or the supervising clinician in developing tools for study implementation including data collection tools and study reference materials
• Provide leadership and guidance to program/research/clinical assistants in the execution of their duties relative to protocol implementation and conduct
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations 

Qualifications

• Current WA state ARNP license with a minimum of one year of post-certification clinical experience required. 
• This position will support our remote and mobile clinics so travel within WA State and flexible hours will be necessary. Will require weekend and evening hours. 
• Two years of clinical research experience is strongly preferred.   
• Previous experience in clinical data collection is preferred.   
• Strong written and verbal communication skills including computer skills, proficiency with MS Word, Excel and PowerPoint are essential.  
• The ideal candidate should be culturally fluent, comfortable and aware of various community backgrounds and perspectives. Experience working with underrepresented and marginalized communities, including communities of color, transgender individuals, and the LGBTQ+ community is preferred. 
• Knowledge of Spanish is helpful.

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 Seattle Vaccine Trials Unit (VTU) (Click here to visit their webpage) is a program within the Vaccine & Infectious Disease Division of Fred Hutchinson Cancer Research Center. Led by Principal Investigator Julie McElrath, the VTU is funded to conduct phase I, II, and III clinical trials. As a clinical research site, the VTU is responsible for the recruitment, selection, and enrollment of study participants, and immunization and clinical monitoring of these participants in clinical trials of investigational agents being studied for the prevention of HIV, SARS-CoV-2, and other infectious diseases. 
  
The Clinical Research Nurse implements and conducts clinical research studies involving human subjects for the Immunology & Vaccine Development research program. The primary focus of the Clinical Research Nurse is screening, enrolling, and following study participants. The position will require willingness to work with COVID-19 and HIV prevention modalities (vaccines, immunoprophylaxis, etc.) as well as working in settings where individuals with active COVID-19 infection will be seen. This position will likely work at the unit’s remote and mobile sites, so flexibility in travel and hours will be important. 

Responsibilities

• The incumbent works under the supervision of the Principal Investigator as part of a clinical research team including the VTU physicians, other clinicians, and other unit personnel. Direct supervision will be by the remote/mobile unit’s supervising clinician. The position requires the performance of responsibilities with a high level of independence within the scope of study protocol(s) and guidelines.
• Determine participant study eligibility, obtain informed consent, and initiate participant randomization and enrollment in research studies in accordance with regulatory and GCP guidelines and institutional policy including:
  • Provide a complete explanation of a study to potential volunteers so as to obtain informed consent
  • Conduct phone (or other remote) visits for protocols involving off-site screening, enrollment, and electronic consenting
  • Record and evaluate medical histories as well social and sexual histories (if required by protocol)
  • Draw blood for screening labs if required per protocol, and interpret the results for inclusion/exclusion criteria, as well as for medical follow-up if needed
  • Provide pregnancy prevention counseling for women, including contraceptive counseling as needed
  • Conduct physical exam assessments per protocol requirements
• Follow study protocol for each participant visit
• Perform clinical procedures including vital signs, vaccine administration, blood draws, IV infusions, and physical exam assessments
• Maintain appropriate source documentation and complete case report forms/electronic case report forms
• Identify, assess, and report adverse events in accordance with protocol and regulatory guidelines and institutional policy
• Provide various forms of health education to study participants and provide appropriate referrals to community medical, social, substance abuse and mental health programs if needed
• Help to maintain the compliance of participants with protocol visit schedule
• Provide support for community education and recruitment with the VTU community educator, recruitment coordinator, and recruiters
• Assist the clinic coordinator and/or the supervising clinician in managing the daily operations of a research study
• Assist the clinic coordinator and/or the supervising clinician in developing tools for study implementation including data collection tools and study reference materials
• Provide leadership and guidance to program/research/clinical assistants in the execution of their duties relative to protocol implementation and conduct
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations 

Qualifications

• Current WA state RN license with a minimum of one year of post-certification nursing experience required.  
• This position will support our remote and mobile clinics so travel within WA State and flexible hours will be necessary. Will require weekend and evening hours. 
• Two years of clinical research experience is strongly preferred.   
• Previous experience in clinical data collection is preferred.   
• Strong written and verbal communication skills including computer skills, proficiency with MS Word, Excel and PowerPoint are essential.  
• The ability to be culturally fluent, comfortable and aware of various community backgrounds and perspectives is critical. Experience working with underrepresented and marginalized communities, including communities of color, transgender individuals, and the LGBTQ+ community preferred. 
• Knowledge of Spanish is helpful. 

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) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. Most recently, the COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the HVTN to utilize their experience and expertise to address the pressing need for vaccines and antibodies against the SARS-CoV-2 virus. The mission of CoVPN is to conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease.

The Project Coordinator position will support the Community Engagement Unit at the HVTN and CoVPN Leadership Operations Centers (LOC). Works under the supervision of the Director, Social & Behavioral Sciences and Community Engagement Unit (SBS/CEU) referring issues and soliciting guidance as necessary. Expected to use initiative and sound judgment in implementing and administering responsibilities within the framework of HVTN & VIDD policies and procedures. Skills in Microsoft Office applications (MS Word, MS Excel, MS Outlook) are necessary and will be applied for moderately complex assignments and projects.

Responsibilities

Perform some or all of the following responsibilities:

• Performs general project coordination duties: expert panel coordination and implementation, records maintenance, and coordination of functions with various individuals and organizations, liaises with IT and Facilities to identify and resolve problems
• Provides general project coordination for CoVPN and SBS/CEU including: preparation of correspondence, gathering and compiling data for reports, arranging meetings, reserving meeting rooms, preparing agendas, and other projects or tasks as assigned. Also responsible for the weekly updates: solicits updates from each group member, compiles/edits/formats, and distributes
• Supports the SBS/CEU team with: coordination of calendars, and communication to the larger CoVPN CE team members
• Arranges one-day virtual expert review meetings; including inviting guests, distributing review materials, editing reports, scheduling ex officio and rapporteur roles, dissemination of reports, and providing general support throughout the meeting as required
• Coordinates the logistics for community listening sessions, town halls and webinar Q&A sessions for community stakeholders, key informants and the larger community
• Codes invoices for payment out of the appropriate budget, ensuring that vendors and consultants are paid promptly and accurately, and maintaining files and documentation for expenses
• Provides logistical and administrative support for community listening sessions, town halls and webinar Q&As
• Coordinates conference calls: sends out announcements, assists with Microsoft Teams and Zoom calls, solicits agenda items, works to schedule new ad hoc and recurring calls, and keeps calendar updated
• Other duties (as needed): creating presentations, updating SBS/CEU and CoVPN documents, special projects for the Director of SBS/CEU, etc. Performs other duties as assigned.

Qualifications

• BA/BS required; other relevant work experience may substitute
• 2-3 years of support experience in a healthcare or academic research environment required
• Position requires a high level of attention to detail and organization
• Excellent written and verbal communication skills
• Good interpersonal skills, and an ability to maintain confidentiality are essential
• Must have demonstrated ability to work independently and take initiative in a dynamic environment
• High level knowledge of Microsoft applications, specifically Word, Teams, Excel, and Outlook are required. Knowledge of Smartsheet and SharePoint 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 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 Data Standards Analyst.

Under general supervision, the Data Standards Analyst contributes to 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, supports coordination efforts with SCHARP staff and network partners to standardize the collection and tabulation of clinical trials data, coordinates and/or leads CDISC working groups, drafts SDTM and ADaM metadata and conversion specifications as well as CRF Global Library form content, maintains awareness of publication updates from CDISC and other data standards or regulatory agencies that impact SCHARP data standards, and 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.

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

• Reviews study builds to ensure they are following Global Library specifications and review and/or approve of the changes as necessary
• Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP SDTM and advises to others in SCHARP on CDASH, SDTM 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
• Draft and/or update Global Library form content as needed based on requirements from SCHARP staff and network partners
• Draft and/or review SDTM metadata and conversion specifications and final datasets
• 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 datasets using Pinnacle 21 to ensure compliance with published specifications
• Coordinates internal CDISC training to SCHARP and our partners as appropriate and provides routine updates to SCHARP staff to ensure current and new staff are aware of materials and training
• Participates in process definitions and SOP development as needed

Qualifications

Minimum qualifications:

• Reviews study builds to ensure they are following Global Library specifications and review and/or approve of the changes as necessary
• 2yr experience working on SDTM
• Stays informed of updates to CDISC data specifications; incorporates new versions of SDTM into SCHARP SDTM and advises to others in SCHARP on CDASH, SDTM 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
• Draft and/or update Global Library form content as needed based on requirements from SCHARP staff and network partners
• Draft and/or review SDTM metadata and conversion specifications and final datasets
• 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 datasets using Pinnacle 21 to ensure compliance with published specifications
• Coordinates internal CDISC training to SCHARP and our partners as appropriate and provides routine updates to SCHARP staff to ensure current and new staff are aware of materials and training
• Participates in process definitions and SOP development as needed

Preferred qualifications:

• Experience as a member of a team completing regulatory submissions
• 5yrs experience working on SDTM
• Experience building transformation pipelines using modern ETL tools such as IBM
• InfoSphere DataStage, Pentaho/Kettle, SQL Server Integration Services, or other
• Knowledge of relational database structures and complex data systems
• 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 McElrath lab’s Site Affiliate Lab (LAB) supports the clinical trials at the Fred Hutch including studies supporting HIV vaccines, COVID-19 vaccines, observational studies, etc. This role will process the blood and specimens taken in the course of these studies to be used for immunological assays. The role will require flexible hours including evening and weekends per schedule.

Responsibilities

• Handle blood products using sterile aseptic techniques and tissue culture techniques
• Isolate and cryopreserve PBMC, separate and aliquot serum, plasma and semen, and isolate cells for DNA preparations
• Handle, receive, ship, and inventory temperature dependent samples following DOT and IATA requirements for diagnostic specimens
• Collect, record, and enter research data. Maintain precise laboratory records. Operate under GLPs
• Communicate and coordinate scheduling with clinical staff
• Maintain and operate all laboratory equipment within the laboratory. Perform general maintenance and cleaning on laboratory equipment, such as centrifuges, microscopes, ultra low freezers, automated cell counters, and biological safety cabinets
• Prepare and maintain reagents, stocks, and cultures necessary to perform work
• Collect and analyze data
• Order and maintain supplies
• Author SOPs for supplies, reagents and equipment as necessary
• Maintain records for experiments and quality control for the laboratory

Qualifications

• High school diploma or equivalent required, BA/BS is preferred
• General computer/data entry experience
• Ability to lift up to 50 lbs
• Experience with working with human biological samples is strongly preferred
• The technician must show initiative, the willingness to take up new skills and responsibilities, and be a team player
• Excellent attention to detail and the ability to work independently are essential to success in this position, as are good communication and organizational skills
• They must also be flexible and willing to work evenings and weekends per schedule

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. Fred Hutchinson Cancer Research Center, home to three Nobel laureates, is an independent, nonprofit research institute based in Seattle. Its interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Its Vaccine and Infectious Disease Division, which is home to more than 70 faculty members, was established to facilitate and enhance the Hutch's efforts in infectious disease prevention and vaccine development. Careers Start Here.

The Newell and McElrath Labs in the Vaccine and Infectious Disease Division of the Fred Hutchinson Cancer Research Center are looking for a Post-Doctoral Fellow to support their joint work role to work on analysis of human cellular adaptive immune responses in the context of responses to vaccines and infectious disease.

The Newell Lab was originally established in 2012 at the Singapore Immunology Network, Singapore and then moved to the Vaccine and Infectious Disease Division of the Fred Hutchinson Cancer Research Center in August 2018 (publication list here.)

The McElrath Lab supports the many projects of Dr. Julie McElrath at the Fred Hutch since 1998. A leader in assay development, the Laboratory continues to improve and explore alternative methods, including systems biology approaches, multiparameter phenotyping and functional characterization of leukocyte subsets, host and viral genomics, as well as multiplex transcriptional, cytokine, and proteomic profiling.

Responsibilities

We seek outstanding Postdoctoral fellows that are interested in diverse aspects of Vaccinology and Immunology, This would involve high dimensional profiling and adaptive receptor analysis of B and T cell responses and would involved the study of COVID-19, HIV and/or tuberculosis infection and vaccination. Our goal would be to understand the basis for the development of protective B and T cell responses to better understand how to formulate more or test the efficacy of the corresponding vaccines. This role would work closely with both labs to take advantage of synergistic technological expertise. This project would involve both lab work as well as heavy computational component and we will likely involved additional collaborators for both aspects.

Qualifications

Required:

• Ph.D. (in Microbiology, Immunology, or protein-design are preferred)
• Strong background in immunology, with emphasis on T and B cell immunity, is important
• Ability to work independently within a very collaborative environment is critical, as are strong written, communication and organizational skills
• Salary will be commensurate with appropriate experience

Applications must include:

• Cover letter discussing your interest in this position
• Curriculum Vitae
• Statement of research interests and career goals
• Names and contact information of at least three referees

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.

A Postdoctoral Research Fellow position is available immediately in the Vaccine and Infectious Disease Division (VIDD) of the Fred Hutchinson Cancer Research Center. The successful applicant will work with Dr. Fabian Cardozo-Ojeda and Dr. Josh Schiffer (see Schiffer Group Webpage) to develop mathematical models that focus on optimizing treatment curative strategies for HIV including but not limited to therapeutic vaccination, latency reversal agents, neutralizing antibody delivery, CAR T cells and antiproliferative agents. The successful candidate will also be able to work on projects developing mathematical models for virus dynamics of SARS-CoV-2 and simulating potential treatment for COVID-19.

Responsibilities

The incumbent will collaborate with laboratory-based virologists, immunologists, oncologists, and clinical investigators from VIDD, to generate datasets appropriate for model testing and validation. The successful applicant will interact with Fred Hutch-based faculty outside of VIDD, plus members of the University of Washington faculty in the Division of Virology and Division of Infectious Diseases.

Qualifications

Suitable applicants should have a Ph.D. degree in statistics/biostatistics, computer science, applied mathematics, biomedical engineering, physics, computational biology, evolutionary biology or other fields with strong quantitative training. Strong programming skills in C/C++, Matlab and/or R and previous experience with differential equation-based models are required. Basic knowledge in control theory is a plus.

Please include a cover letter with your application, describing your research accomplishments as well as detailing your interest and suitability for this position.

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.

Dr. Fei Gao is seeking a Post Doctoral Research Fellow in the department of Biostatistics, Bioinformatics and Epidemiology in the Vaccine and Infectious Disease Division. 

Responsibilities

We are seeking a recent or prospective doctoral graduate (Ph.D. or equivalent qualification) with strong training in biostatistics or statistics.  The postdoctoral fellow-research associate will work directly with Dr. Fei Gao, and will conduct research on statistical methods for treatment efficacy evaluation for active-controlled HIV prevention trials. The work will consist of methodological development, statistical programming and simulation, and application of methods for data analysis.  The products of the research will be academic presentations and peer-reviewed publications led by the post-doctoral fellow.  

Qualifications

A Ph.D. in statistics or biostatistics, or equivalent degree is required.  Candidates must have a strong methodology background and excellent communication skills (verbal written and presentation). Previous experience with clinical trials, survival analysis, or causal inference 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 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 Schiffer Group at the Fred Hutchinson Cancer Research Center is seeking to hire a Post-doctoral Fellow to work on mathematical modeling of viral diseases. Particular emphasis will be on SARS Co-V-2 as well as other respiratory viruses.

The successful applicant will work with Dr. Joshua T. Schiffer to develop mathematical models that focus on optimizing treatment of viral infections, and in particular curative strategies for HIV and COVID-19. The candidate will also collaborate with laboratory-based virologists, immunologists, oncologists, and clinical investigators from VIDD, to generate datasets appropriate for model testing and validation. The successful applicant will interact with Fred Hutch based faculty outside of VIDD, plus members of the University of Washington faculty in the Division of Virology and Division of Infectious Diseases.

Qualifications

Suitable applicants should have a PhD degree in statistics/biostatistics, computer science, applied mathematics, biomedical engineering, physics, computational biology, evolutionary biology or other fields with strong quantitative training. Strong programming skills in C/C++, Matlab and/or R and previous experience with differential equation-based models are required. Basic knowledge in control theory is a plus.

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) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. Most recently,
the COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the HVTN to utilize their experience and expertise to address the pressing need for vaccines and antibodies against the SARS-CoV-2 virus. The mission of CoVPN is to conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease.

Job Summary

The Regulatory/Quality Project Manager position will support the HVTN/CoVPN’s Leadership Operations Center (LOC) for Quality & Regulatory Affairs, as needed, by managing the operations of projects or studies. The incumbent works under the direction of the HVTN/CoVPN Director of Quality & Regulatory Affairs. Special skills and knowledge are applied in managing research and administrative activities, such as developing policies, procedures, and methods for project/study implementation, as well as carrying-out complex clinical trials operations and research assignments.

Responsibilities

Perform some or all of the following responsibilities:

• Set goals and timetables for proactively tracking sites’ target dates for regulatory and ethics body submissions and approvals and completion of Protocol Activation items in order to prevent delays in study start at sites
• Trouble-shoot potential delays in Protocol Activation items by working with sites and other members of the LOC, Statistical Data Management Center, and Laboratory Center, and outside collaborators, as needed
• Support the Director of Quality & Regulatory Affairs in project management tasks related to the Quality Management System and Trial Master Files
• Support the Director of Quality & Regulatory Affairs in logistical planning for African regulatory/ethics engagement activities
• Manage onboarding new sites to get them set up in HVTN/CoVPN’s regulatory tools, systems, and processes
• Coordinate translation and distribution of safety-related documents to sites
• Coordinate the regulatory aspects of specimen management, including tracking specimen destruction triggers and completing tasks associated with auxiliary studies
• Work with protocol team leadership at DAIDS and DAIDS contractors to register clinical trials to NIH’s clinicaltrials.gov website
• Compile Clinical Study Reports and facilitate applicable internal reviews
• Manage submissions to the single IRB
• Provide administrative support for external audits, ensuring professional and timely delivery of essential documents to auditors
• Document operating procedures using SOPs, WPGs, and checklists so others may fill in if needed
• Perform other tasks as assigned

Qualifications

Required:

• BA/BS in related field
• 3-5 years of post bachelor’s related project/study management experience in a research setting. Other relevant work experience may substitute.
• Sharp critical thinking skills
• High level of attention to detail and organization
• Excellent written and verbal communication skills
• Good interpersonal skills and an ability to maintain confidentiality are essential
• Demonstrated ability to work independently and take initiative in a dynamic environment
• High level knowledge of Microsoft applications, specifically Word, Excel, PowerPoint, Teams, and Outlook

Preferred:

• MA/MS in a related field
• 3 years of post-masters related project/study management experience in a research setting.
• Experience in Lean methodologies highly desired
• Knowledge of SharePoint, Blueworks, and SmartSheet

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 Administration Manager I (RAM I) will be responsible for the successful pre- and post-award management of grants and contracts of the sponsored research portfolio of the Biostatistics, Bioinformatics, and Epidemiology (BBE) Program in the Vaccine and Infectious Disease Division (VIDD). They prepare, negotiate, administer, and maintain grant budgets in accordance with the proposal or application guidelines, statement of work, or Notice of Award. They ensure compliance with all sponsor rules and regulations. They ensure the accuracy of project budgets and contracts, reconcile expenditures throughout project life-cycle, and track progress of awards from pre-award to project closeout.

Responsibilities

This role closely interacts with program principal investigators (PI), faculty and staff, and collaborators within and outside of the Fred Hutch. The RAM I establishes and maintains professional relationships with award sponsors and regulatory agencies. They also advise PIs and the BBE Program Operations Director (POD) on relevant matters, develop effective solutions to research administration issues, and provide input to broader program and division planning as needed. The RAM I supervises the team of Research Administrators and is responsible for their performance management, professional development, and handling any HR actions related to the team. They also participate in program, divisional or institutional improvement projects and problem resolution related to research administration. This position reports to the BBE POD.

This position works independently in developing goals for the BBE Research Administration team and determines how to accomplish those goals. The incumbent must be comfortable managing in a matrixed organization receiving work direction from PIs and BBE leadership.

Research Administration:

• Support BBE faculty (and trainees, as applicable), performing all pre-and post-award activities per NIH or other sponsoring institutions including the Bill & Melinda Gates Foundation; developing budgets for assigned grants, contracts or other funding requests; coordinate preparation of appropriate forms for grants/contracts and agreements and ensure all applications are fully compliant with institutional, federal, state, and local policies and regulations.
• Manage assigned subcontract administration awarded by BBE faculty.
• Manage assigned BBE faculty award programs, trainee support programs, emerging opportunity award programs, and pilot project programs including pre- and post-award administration, managing the application process.
• Interface with faculty to develop, negotiate, and manage highly complex sponsored budgets, working to anticipate new project support needs and budget accordingly and ensure budgets are amended to reflect revisions to related statements of work.
• Provide ongoing cost analysis for studies to ensure sponsored projects are adequately funded; provide budget information to internal partners for negotiation of budget revisions with sponsors.
• Track all projects in startup, developing plans with parallel workstreams and clear timelines, communicating between stakeholders, and holding accountable the team members whose input is required.
• Ensure project invoices are submitted and sponsor payments are received in a timely manner.
• Coordinate project audits and close-outs.

Research Administration Team Leadership:

• Track the BBE grant portfolio (i.e. active and pending awards) and provide summaries to BBE program leadership as requested.
• Oversee all grant application activities and award funding compliance, resolving all escalated issues to ensure successful submissions.
• Oversee all submissions to Institution Review Office (IRO) and other regulatory committees; resolve all escalated issues.
• Develop short and long term goals, procures necessary resources and determines courses of action to accomplish goals for the research administration function.
• Supervise BBE Research Administration staff to include hiring, performance evaluation, professional development, handling disciplinary action, layoff and termination issues.
• Work with Center and VIDD Admin to continuously identify operational issues and areas of improvement to ensure optimum conduct of research studies.
• Participate in divisional or institutional improvement projects and problem resolution related to research administration.

Qualifications

Required:

• Bachelor’s degree in Business Administration, Public Administration, or related field; an equivalent combination of education and experience may be substituted for minimum education requirement
• Minimum of five years experience in pre-award and post-award research administration or grants and contracts management, ideally managing Federal or State sponsored awards in a complex, multi-faceted portfolio
• At least three years of experience managing direct reports and conducting performance appraisals
• Experience with business development and industry sponsored contracts
• Experience with regulatory agencies and reviewing IRB and IACUC administrative documents
• Knowledge of relevant regulatory requirements affecting sponsored research, and ability to apply this knowledge to their portfolio and share with the Research Administration team
• Ability to navigate complex internal systems and departments while exercising sound judgement and discretion
• Proficient with complex budget development and use of financial reporting tools
• Excellent time management and prioritization skills, with the ability to effectively manage multiple and competing demands
• Excellent written and oral communication skills and the ability to communicate effectively with faculty and staff in a variety of roles
• Intermediate skills in Word, Adobe Acrobat Pro, and Outlook
• Advanced skills in Excel including familiarity with pivot tables and look up tables
• The ability to work independently, soliciting direction or assistance from the Program Operations Director as required
• Highly organized and detail oriented
• Demonstrated ability to work successfully as part of a diverse team with a commitment to equity and inclusion
• A cover letter is required for this position

Preferred:

• Master of Business Administration (MBA) or Master of Public Administration
• Seven years of progressive experience in research administration or grants and contracts administration
• Experience with contract negotiation and vendor management
• Experience working in a research organization, a university/medical school setting, or other complex non-profit organization

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 is a part-time (0.5 FTE) Research Administrator II position to support two faculty members and their research groups related to general administrative support, fiscal operations and regulatory administration in the Infectious Disease Sciences Program. The incumbent works independently in performing responsibilities. Judgment is used daily in interpreting policy, representing the faculty member, interacting with Center staff and outside organizations, and working with highly sensitive or confidential information.

Responsibilities

Administrative Support:

• Provide direct support to the faculty members; coordinate research operations, prepare background information in preparation for faculty’s professional commitments and meetings; maintain supervisor’s calendar and establish priorities; coordinate arrangements for meetings at destination; screen, prioritize, and distribute mail.
• Responsible for independently drafting/recording minutes; compose and/or type letters, acknowledgements, notifications, confidential and sensitive materials, Internet searches, etc.
• Manage and update content on faculty members’ web and lab pages
• Arrange conference and meeting schedules, travel agendas, compensation for travel, and activities as required by the Faculty member(s)
• Manage seminar series and related events/special projects for faculty members as required
• Coordinate and edit revisions to book chapters, manuscripts, articles, reports and teaching materials of a highly technical nature. Coordinate documentation preparation with publication deadlines, grant deadlines, collaboration efforts and other projects.
• Maintain reference database and filing system for faculty member(s) including, but not limited to: professional CV’s and Biosketches, Other Support Information, Manuscripts, Endnote and other documentation. Ensure that all information is up to date, as needed.
• Develop a working knowledge of key faculty and staff within the various Seattle Cancer Care Alliance / Fred Hutch / University of Washington departments and divisions to facilitate effective and independent communication and administration. This may require attending various staff meetings within the program.

Budget/Fiscal Support:

• Partner with IDS finance to resolve identified budget and expense issues
• Identify and discern discrepancies with expenses, find solutions and escalate as needed
• Reconciliation of PIs budgets/expenses on sponsored and non-sponsored research projects
• Work closely with IDS finance team for research and clinical trials budgets
• Develop, monitor, track and project seminar series budgets
• Reconcile PIs and associated staffs’ pro-cards monthly

Funding Source Administration:

• Assist in grant preparation process, producing accompanying reports and non-technical sections, and assembling proposal, reviewing for accuracy and completion prior to submission with IDS Finance team.
• Track progress and milestones on research projects.

Regulatory Support:

• In consultation with PI(s) and IRB Team, prepare or review portions of applications as necessary.
• Manage renewal timelines and ensure completion of regulatory documents in a timely manner in coordination with the IRB Team
• Track progress and milestones on research projects.

Qualifications

• Bachelor’s degree in English or the humanities preferred, or degree in scientific field directly related to department/program. Minimum of three years progressively complex administrative experience. Additional experience may substitute for educational requirement.
• Must be proficient working on Mac platform as both faculty members work from this platform and previous experience working on the related programs, Word, PowerPoint, Excel, Endnote, SharePoint and Adobe software.
• Ability to handle multiple projects at one time (planning and prioritization), strong editing and writing skills, and excellent communication skills with outstanding attention to detail. Must have skill at solving problems that involves excellent judgment and capability of independent thinking.
• Knowledge of medical terminology is highly desirable
• Experience with grant preparation and/or Institutional Review Board (Human Subjects) applications is highly desirable

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center (Fred Hutch), 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.

Fred Hutch Global Oncology (GO), a Cross-Divisional program overseen by the Director’s Office at Fred Hutch, has a mission to reduce the global burden of cancers, especially in low and middle-income countries, through the advancement of research and the development of new low-cost prevention and treatment strategies.  A cornerstone of the program is a decade-long alliance with the Uganda Cancer Institute (UCI) that advances research, capacity building, and cancer care in Uganda. 

The Vaccine and Infectious Disease Division (VIDD), one of five scientific divisions at Fred Hutch, addresses the growing need for treatment and prevention strategies for infectious diseases worldwide. VIDD is comprised of three research programs—Biostatistics, Bioinformatics & Epidemiology (BBE), Immunology & Vaccine Development (IVD), and Infectious Disease Sciences (IDS).

OVERVIEW

This Research Administrator IV position is based in Seattle and is a part of a broader team with members both in Seattle and Uganda. This position will report to the Director of Program Operations in VIDD and the Finance and Administrative Manager in GO. The incumbent will collaborate and is integrated into VIDD and GO. The incumbent will work with other GO staff based in Seattle to contribute to the program’s strategic objectives in an international research setting and is also expected to be integrated into the VIDD financial, regulatory and administrative and operations teams. The Research Administrator IV will principally manage all aspects of international and domestic sponsored, non-sponsored and philanthropic funding for the assigned faculty portfolio. Additionally, the position supports faculty by managing their research portfolios, planning for and ensuring compliant and effective funding, budget support of assigned Principal Investigators and their research groups. The Research Administrator IV works autonomously and is expected to use initiative and sound judgment in operating within the framework of programmatic policies and procedures.

Responsibilities

GO International Financial Operations (50%)

Pre/Post Award Grant Support

• Works closely with faculty to prepare all budget and related financial/administrative documents pertaining to the GO component (on and off-site) for all applicable grant applications and progress reports.
  • Liaise with Ugandan colleagues for pertinent information regarding their respective sections, i.e. lab director, clinical trials director, and clinical project managers.
• Consult and provide financial approval for GO staff coverage on sponsored awards (on and off-site) on PI studies and coordinate with relevant HR staff, advising of funds, to hire or retain personnel to implement research projects. Advise faculty on relevant grant financial/budgetary issues and develop effective solutions.

Research and Finance Operations

• Participate as part of the broad finance team, regularly liaising with international colleagues.
• Manage GO’s international industry sponsored clinical research and philanthropic funding sources.
  • Takes the lead in preparing budgets and all other related financial/administrative documents, enters in Hutch Grants, and prepares any required reporting.
  • Works directly with industry sponsor contacts and Fred Hutch Clinical Research Services or philanthropic sponsor contacts and Fred Hutch Philanthropy regarding agreements, required reporting materials, invoicing, or to resolve any related questions or issues
• Regular and timely budget-to-actual reporting of international industry sponsored clinical research and philanthropic funding sources. Maintain current projection worksheets and create new ones, as needed, and update on a monthly and ad hoc basis. Prepare cost transfers, as needed.
• Proactively partner with clinical project managers, in Uganda or other international settings, to ensure effective financial administration of all GO studies.
• Review and approve procurement requests, FMS requisitions, and OnBase invoices for all GO studies. Coordinate with division research administrators, as applicable.
• Prepare ad hoc budget copy requests for all GO studies and revising them, as needed (e.g. regular requests for copies of salary redacted budgets for clinical project managers or truncated budget requests for various Ugandan regulatory offices).
• Liaise with appropriate regulatory staff in Seattle to track status of regulatory approvals and subsequent financial regulatory forms for all GO studies.
• Review effort monthly for all GO staff on sponsored awards (on and off-site) for GO Finance Manager approval.
• Serve as a resource for international collaborator’s grants administration office.
• Perform related duties as assigned.

VIDD (50%)

Pre/Post Award Grant Administration

• Support GO/VIDD faculty (and trainees, as applicable), performing all pre-and post-award activities per NIH or other sponsoring institutions including the Bill & Melinda Gates Foundation; developing budgets for assigned grants, contracts or other funding requests; coordinate preparation of appropriate forms for grants/contracts and agreements and ensure all applications are fully compliant with institutional, federal, state, and local policies and regulations.
• Manage assigned subcontract administration awarded by GO/VIDD faculty.
• Manage assigned GO/VIDD faculty award programs, trainee support programs, emerging opportunity award programs, and pilot project programs including pre- and post-award administration, managing the application process.

 
Budget/Fiscal Support

• Develop, monitor, track and project budgets for a complex portfolio of projects with multi-variable aspects (multi-site, sub awards etc.
• Develop, run and analyze reports to identify issues and develop recommendation.
• Develop customized report formats to share information with broad audiences across the organization.
• Independently determine proper placement for expenses and correct errors to ensure accuracy.
• Prepare budget projections, reconcile expenditures, and monitor the payroll changes.

Funding Source Administration

• Provide strategic guidance in consultation with IDS and IVD Programs on grant submissions and post award activity by conducting tasks such as:
  • Working with faculty and program leadership to develop strategies for responses/requests.
  • Securing the necessary signatures for grant and contract applications through Program/VIDD, and tracking approval process to ensure appropriate documentation.
  • Consulting with funding agencies and/or respective Center departments to resolve problems on processes, procedures and/or expenditures.

Qualifications

Minimum Qualifications:

• Bachelor’s degree required, with credentials in business, finance, or public administration preferred
• Minimum of three years of experience working with grants/contracts and building, overseeing, and managing budgets, federal funding preferred.
• Strong financial management skills including but not limited to budgeting and forecasting.
• Self-motivated with strong analytical skills and extreme attention to detail, able to exercise independent judgement and make appropriate decisions.
• Strong computer skills - ability to develop and perform complex calculations in Microsoft Excel and proficiency with a variety of software packages including Microsoft Outlook, Excel, Word, Teams, SharePoint, Adobe Pro, WebEx and Skype.
• Well-developed verbal and written communication skills, including an ability to understand complex problems, to collaborate and explore alternative solutions. Ability to organize thoughts and ideas into understandable terminology. Previous experience working across different cultures is preferable.
• Ability to multitask without loss of efficiency or accuracy, using strong organizational and time management skills and to communicate status of projects to key persons/decision makers on a proactive basis.
• Work and sustain attention with distractions and/or interruptions and work effectively under stressful circumstances, such as tight deadlines. Position requires flexible work hours to regularly connect with our international partners and to meet deadlines/deliverables.
• Position may require occasional travel to Uganda or other international locations (less than 10% of the time).

Key Skills:

• Experience working with international research.
• Experience working with clinical trials.
• Comfortable working in a fast-paced environment. This includes the ability to perform multiple duties received from multiple sources and/or situations requiring speed.
• Experience working with international partners across time zones.

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 laboratory, HIV Vaccine Trials Network (HVTN) and Coronavirus Prevention Network (CoVPN). Our lab is recruiting a research technician to primarily perform assays to characterize antiviral T and B-cell responses. The incumbent will be expected to perform complex research assays, utilizing flow cytometry to evaluate vaccine-induced cellular immune responses in vaccine recipients participating in clinical trials of investigational vaccines for SARS-CoV-2/COVID-19, HIV, malaria, tuberculosis (MTB), and Ebola. They will be responsible for performing and coordinating the assays with other technicians and analyzing the data. They will interpret and report on experimental results and assist with data presentation. They will assist in writing laboratory SOPs, reports, and other documentation. They will report to a project manager and work closely with a technical team.

The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS or other 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 HVTN laboratory is responsible for conducting laboratory-based studies to evaluate the immunogenicity of investigational vaccines.

Responsibilities

• Maintain a high level of accuracy for all work
• Work well as team-member, participate in positive communication, and foster an environment that allows all laboratory staff to work well together
• Independently perform flow cytometry, FACS sorting, and other experimental assays, such as MSD, ELISpot and ELISAs
• Perform flow cytometry (intracellular cytokine staining and FACS sorting), ELISPOT and MSD/Luminex/ELISAs for characterization and monitoring of T and B cell responses
• Proactively prepare reagents for experiments and for general lab use
• Troubleshoot and optimize experimental methods, results and analysis
• Maintain accurate documentation for experiments and quality control for the laboratory
• Carry out maintenance, trouble-shooting and QC of laboratory equipment
• Review the literature to stay informed on the HIV vaccine field or immunological assays
• May perform data analysis, interpretation, and statistical analyses
• Other duties as assigned

Qualifications

• A bachelor’s degree in immunology or biological science and preferably 2 years of laboratory experience.
• Motivation, adaptability and ability to be a strong team player are essential, as is a keen interest in the SARS-CoV-2/COVID-19 & HIV vaccine field.
• Specific experience with flow cytometry, immunology, cellular assays, and tissue culture are preferred.
• The candidate must be someone with great attention to details, well-organized, self-motivated, and able to efficiently manage time and experiments.
• Experience in a GLP or GCLP setting or clinical experience, with strong documentation skills is also desirable.
• Applicants must be willing to work with biohazardous/infectious agents (e.g., bloodborne pathogens, including SARS-CoV-2/COVID-19 & HIV-1) and also be flexible and willing to work evenings and weekends per work schedule.
• 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 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 Newell Lab is a highly collaborative group within the Vaccine and Infectious Disease Division of the Fred Hutchinson Cancer Research Center. The lab focuses on the application and development of novel approaches for studying antigen-specific T cells in the context of cancer and infectious diseases. In addition to leveraging expertise in the use of highly-multiplexed peptide-MHC tetramer staining in conjunction with mass cytometry to deeply profile antigen-specific T cells, novel single cell sequencing and computational approaches are being used that allow for improved examination of T cell phenotypes, function, antigen specificity, as well as T cell receptor repertoire. Although the lab focuses mostly on studying the roles of T cells in human health and disease, mouse tumor systems are also employed. A major goal of lab is to identify useful biomarkers of clinical outcomes that take advantage of modern experimental and computational approaches with particular focus on human infectious diseases (most recently including studies of adaptive responses in the context of COVID-19) and cancer.

Our Lab is seeking an outstanding technician to work on developing and implementing cutting edge analysis to investigate the roles of T cells in various models of cancer and infectious disease.

Responsibilities

• Learning nuances of implementation of mass cytometry for the analysis of relevant cellular samples
• Application of highly multiplexed peptide-MHC multimer analysis using mass cytometry
• Lab management and organization
• Initiate and carry out scientific projects, under the supervision of Evan Newell

Qualifications

• BA/BA in a qualified field
  
  • Research Techn I minimum qualifications- BA/BS in a scientific field required. Must have scientific knowledge in the area of study and basic laboratory skills. Independent research experience in addition to school lab experience is usually necessary.
  • Research Techn II minimum qualifications- Intermediate level position requiring 2 years previous experience working in a laboratory and BA/BS. Independent research experience outside of laboratory course work is usually necessary.
• Experience with flow cytometry (mass cytometry experience not required)
• Good organization skills
• An ability to learn new techniques and troubleshoot assays
• Good team player, independent, self-driven with good interpersonal skills
• Computer programming or bioinformatics skills would be very advantageous
• Experience with protein expression and purification would also be advantageous
• Several years of research lab experience 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 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 laboratory and the HIV Vaccine Trials Network (HVTN). Our lab is recruiting an experienced research technician to perform assays to characterize T and B cell responses induced by vaccination. The incumbent will be expected to lead and perform complex research assays, utilizing flow cytometry to evaluate vaccine-induced cellular immune responses in vaccine recipients participating in clinical trials of SARS-CoV-2/COVID-19 & HIV or other infectious disease, such as malaria or TB, investigational vaccines. They will be responsible for performing and coordinating the assays with a technical team, and collecting and analyzing the data. They will interpret and report on experimental results and assist with data presentation. They will assist in writing laboratory SOPs, reports, and other documentation. The technician will report to a staff scientist and work closely with a technical team.

The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS or other 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 HVTN laboratory is responsible for conducting laboratory-based studies to evaluate the immunogenicity of investigational vaccines.

Responsibilities

• Maintain a high level of accuracy for all work
• Work well as team-member, participate in positive communication, and foster an environment that allows all laboratory staff to work well together
• Independently, lead and perform immunological, flow cytometry, FACS sorting, and other experimental assays
• Troubleshoot and optimize experimental methods, results and analysis
• Lead, train or coordinate other technicians, or team members on laboratory techniques and assays
• Review the literature to stay informed on the HIV vaccine field or immunological assays
• Prepare and present written or oral progress reports concerning studies including assembly, organization, and interpretation of data
• Maintain accurate documentation for experiments and quality control for the laboratory
• Supervise and carry out maintenance, and trouble-shooting and QC of laboratory equipment
• May perform data analysis, interpretation, and statistical analyses
• Other duties as assigned

Qualifications

• This is an intermediate level position requiring a BA/BS degree in biology, immunology or related field and 1-2 or more years of applicable research laboratory experience or a combination of experience and advanced education.

  • Research Techn I minimum qualifications- BA/BS in a scientific field required. Must have scientific knowledge in the area of study and basic laboratory skills.  Independent research experience in addition to school lab experience is usually necessary.

  • Research Techn II minimum qualifications- Intermediate level position requires a BA/BS and 2+ years experience working in a laboratory. Independent research experience outside of laboratory course work is required.

• Experience with flow cytometry, COVID, HIV/AIDS, immunology, and/or cellular assays are strongly desired.
• Motivation, adaptability and ability to be a strong team player are essential, as is a keen interest in the SARS-CoV-2/COVID-19 & HIV vaccine field.
• The candidate must be someone with great attention to details, well-organized, self-motivated, and able to efficiently manage time and experiments. Experience in a GLP or GCLP setting or clinical experience, with strong documentation skills is also desirable.
• Applicants must be willing to work with biohazardous/infectious agents (e.g., bloodborne pathogens, including SARS-CoV-2/COVID-19 & HIV-1) and also be flexible and willing to work some evenings and weekends.
• 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. 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.

The Hill Group in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center is recruiting a Senior Fellow to conduct research on infections in immunocompromised patients. Dr. Hill and his research team are conducting multiple epidemiologic and translational studies of strategies to improve the diagnosis, treatment, and prevention of infections after CAR-T cell therapy, hematopoietic cell transplantation, and other immunosuppressive treatments.

Responsibilities

The responsibilities of this position will include leading independent and collaborative studies from start to finish, including study planning, obtaining regulatory approval, collecting and generating data, assisting with statistical analyses, and publication of results. In addition to investigator-initiated research, applicants with an M.D. may provide infectious disease consultation for cancer patients at the Seattle Cancer Care Alliance outpatient Transplant ID Clinic under the supervision of an attending ID physician. Additional opportunities include training in the conduct of industry-sponsored clinical trials and other opportunities to build research skills.     

Qualifications

We are seeking candidates with an M.D. or equivalent degree who have completed an accredited Infectious Diseases training program. Candidates should be highly motivated and capable of working independently in a team environment with strong writing, verbal communication, and problem-solving skills. Candidates with prior research training and a publication record are 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 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 Senior Clinical Data Coordinator (Sr CDC) who monitors the collection, processing, performs routine data entry and quality control of study data. The Sr CDC work within a network/study/protocol team to support the policies and goals of each project assigned. They develop and maintain successful working relationships with their team and specific research sites to ensure and maintain data integrity and quality.

The Sr CDC adheres to SCHARP Standard Operating Procedures (SOPs), Work Practice Guidelines (WPGs), applicable clinical trial regulations, and study confidentiality requirements.

This position's primary work location will be onsite at Fred Hutch's Seattle campus. 

Responsibilities

The Sr CDC will work under the supervision and mentoring of Sr. Clinical Data Managers and departmental leadership. The Sr CDC uses judgment in making decisions regarding routine data management tasks. They will refer all non-routine decisions for the management of study data to study/protocol leads and/or departmental leadership. Responsibilities may include some or all of the following:

• Perform routine data entry including first and second pass validation as required
• Adhere to current data entry priorities using appropriate tools and resources
• Add and resolve QC notes to data fields
• Act as liaison for data management issues between SCHARP study teams and research sites
• Attend assigned SCHARP study team meetings and conference calls
• Assist in development of Case Report Forms for assigned studies
• Manage study data for assigned studies
• Assist in the maintenance of the study database including routine revisions or additions
• Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures as appropriate per CDMS
• 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 production and review of Data Operations SOPs and WPGs
• Assist Data Operations staff in resolving non-routine data entry issues
• Perform additional tasks as appropriate and assigned

Qualifications

• Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline
• 2+ years’ experience in the pharmaceutical/clinical research environment as Clinical Data Coordinator or equivalent role
• 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 in when to seek support
• Ability to work independently and to work efficiently under pressure
• Consistent, dedicated, versatile and able to prioritize and multi-task
• A strong team player with optimistic attitude