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 HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally. Our organization conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.
The Project Coordinator position is a unique role that will support the HVTN’s Leadership Operations Center (LOC) for the Regulatory Affairs and Site Operations Units. The incumbent works under the direction of the Regulatory Affairs Director and under the indirect direction of the Site Operations Study Coordination Manager. Special skills and knowledge are applied in coordinating research and administrative activities and in carrying-out moderately complex clinical trials operations and research assignments.
The HVTN Project Coordinator provides support to both the Site Operations and Regulatory Affairs teams. The Project Coordinator will perform some or all of the following responsibilities:
Support Site Operations for HVTN
1. Work with Clinical Trials Managers to maintain and assure adherence to major milestones and study specific activities.
2. Coordinate research and administrative activities with Clinical Trials Managers, ensuring all projects are completed according to project/study timelines.
3. Organize study protocol/operations conference calls, e-mail communications, and meetings. Tasks to include polling call participants, distributing call announcements, agenda, meeting materials and minutes.
4. Create protocol-specific aliases to effectively and efficiently distribute study related written communications to network members.
5. Produce and distribute weekly and monthly enrollment reports to the appropriate groups.
6. Participate in the development, review, production and distribution of training materials for on-site training, study-specific procedures, and other study materials related to data collection/management/randomization. Manage translation of study materials for non-US sites.
7. Assist Clinical Trials Managers in documenting procedures and policies, and formatting study related special procedures and forms.
8. Participate in working groups, special projects, workshops and trainings as needed; attend regular group and network meetings.
9. Perform other administrative tasks such as searching and collecting publications, updating studies related templates and documents, unblinding studies, arranging logistics for on-site training, assisting the production of Ops Day materials etc.
10. Serve as a backup liaison with study site staff regarding protocol implementation and operational issues.
11. Assist Director/Associate Director for Site Operations, Study Coordination Manager, and Clinical Trials Managers with special projects.
12. Performs other responsibilities as required.
Support HVTN Regulatory Affairs
13. Collect and verify each site’s study documentation and other requirements as part of Protocol Activation process, which will then permit enrollment to start at the site.
14. Track sites’ Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.
15. Provide administrative support for submissions to the Fred Hutch IRB, including assembling submission packages and electronically filing submissions and approvals.
16. Draft regulatory-related communications to support sites’ completion of protocol-specific financial disclosure forms.
17. Coordinate translation and distribution of safety-related documents to sites.
18. Serve as the Financial Disclosure Coordinator: participate in refining cross-Network process; prepare data for annual solicitation; compile and organize results of solicitation for Regulatory Ethics Conflict of Interest (RECOI) subcommittee review; provide administrative support to the RECOI subcommittee.
19. Perform special regulatory-related tasks as assigned.