Project Coordinator, Regulatory Affairs - HIV Vaccine Trials Network

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

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 with minimal side effects. 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 the world's largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.

The Project Coordinator position will support the HVTN's Leadership Operations Center (LOC) for the Regulatory Affairs Unit. The incumbent works under the direction of the Regulatory Affairs Director. Special skills and knowledge are applied in coordinating research and administrative activities and in carrying-out moderately complex clinical trials operations and research assignments.

Perform some or all of the following responsibilities:
- 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.
- 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.
- Provide administrative support for submissions to the Fred Hutch IRB, including assembling submission packages and electronically filing submissions and approvals.
- Provide administrative support for the sign-off of site Material Transfer Agreements.
- Draft regulatory-related communications to support sites' completion of FDA form 1572s/Investigator of Record Agreements and protocol-specific financial disclosure forms.
- Coordinate translation and distribution of safety-related documents to sites.
- 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.
- Perform special regulatory-related tasks as assigned.

- BA/BS in related field required. MA/MS desired. Other relevant work experience may substitute.
- 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, Excel, and Outlook are required. Knowledge of SharePoint is preferred.

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