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.
Provide regulatory leadership to the Cancer Immunotherapy Trials Network in terms of planning, implementing and operating clinical trials in a regulatory compliant environment.
Incumbent works independently to ensure regulatory compliance within CITN COSC and at participating CITN sites.
- Serve as regulatory liaison for interdepartmental and external agencies including, but not limited to Cancer Treatment Evaluation Program (CTEP), Office for Human Research Protections (OHRP), Regulatory Affairs Branch (RAB), the Fred Hutchinson Cancer Research Center’s Institutional Review Office, Cancer Research Support, and participating CITN site IRBs.
- In conjunction with Cancer Immunotherapy Trials Network (CITN) Protocol Managers, facilitate and track trial protocols through all applicable review and approval processes including, but not limited to CTEP, FDA, IRBs, RAB, and in-country agencies.
- Ensure that participating CITN research sites have complied with all applicable regulatory requirements of the site registration process.
- Provide regulatory oversight on safety reporting for the CITN.
- Assist in compiling materials needed for investigational new drug (IND), submissions, IND safety reports, and annual reports as required.
- Design, develop and implement SOPs that ensures the CITN COSC conducts its regulatory activities in accordance with FDA/ICH regulations and guidance documents.
- Serve as an internal resource to address and resolve any questions or issues of a regulatory nature.
- Prepare and submit regulatory documents, as well as manage the regulatory archive.
- Monitor, interpret and validate current and changing regulatory legislation and instructional polices, and ensure new regulations or changes to existing regulations are communicated throughout the CITN COSC, and share potential impact these changes may have on ongoing protocols.
- Manage sites who utilize the FHCRC IRB as the IRB of Record.
- Provide expert review of non-lead IRB sites consent forms and other applicable regulatory documents.
- Coordinate with others, as appropriate, to resolve highly complex or extraordinary regulatory problems that may arise.
- Provide advice and counsel to the CITN COSC and participating CITN sites regarding regulatory requirements.
- Identify potential regulatory risks to the operational plans of the CITN COSC, and propose options to mitigate risks.
- Supervision of junior regulatory affairs staff as needed.
- Minimum BS in Life Sciences, advanced degree preferred.
- At least 7 years of experience working within the regulatory environment.
- Extensive and current working knowledge of FDA regulations, GCP, and International Conference on Harmonization guidelines.
- Honed knowledge of clinical trial safety issues.
- Excellent interpersonal skills and attention to detail.
- Professional Society Certification (RAC) and background in pharmaceutical regulatory affairs or law strongly desired.