Regulatory Affairs Manager

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

Fred Hutchinson Cancer Research Center, home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Center's five scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Hutchinson Center, in collaboration with its clinical and research partners, the University of Washington and Seattle Children's, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Join us and make a difference!

The Uganda Cancer Institute (UCI)/Hutchinson Center Cancer Alliance is a collaborative venture to establish a state-of-the-art cancer treatment facility located in Kampala, Uganda. The aim of this joint effort between the Program in Global Oncology at the Hutchinson Center, and the Uganda Cancer Institute, is the development of new low-cost prevention and treatment strategies for ameliorating the high burden of infection-related cancers. Clinicians and scientists work together to enhance patient access to care, diagnosis and research-based treatment. The UCI/Hutchinson Center Cancer Alliance seeks to develop effective prevention and treatment strategies for infection-associated cancers to benefit the millions of people in Uganda, the United States and worldwide who suffer from these malignancies. The Program in Global Oncology is additionally planning expansion into several countries worldwide, with the goal of conducting high-quality research and capacity-building on an international scale.

Incumbent will work independently with the Fred Hutch Institutional Review Office (IRO) and the Office of General Counsel in consultation on regulatory compliance issues. The incumbent provides human subjects protection knowledge and expertise to help facilitate ethical review and ensure regulatory compliance within Fred Hutch and at participating Global Oncology sites. The incumbent works independently in performing job assignments and uses good judgment in developing and documenting procedures, preparing submissions to IRBs and distributing communications. The incumbent may coordinate / carry out special regulatory projects. This position will report to the Research Operations Manager based in Seattle.

- Serve as regulatory liaison for interdepartmental and external agencies including, but not limited to Global Oncology (GO); Uganda Cancer Institute (UCI); Office for Human Research Protections (OHRP); the Fred Hutchinson Cancer Research Center's IRO; and participating Global Oncology site regulatory committees.
- Perform regulatory review of study documents (e.g., protocol, ICFs, etc) during protocol development, as needed. Maintain documentation of the review. Communicate any changes needed to the investigators.
- Prepare regulatory documents for submission to all applicable regulatory bodies, including, but not limited to, providing required supplemental documentation and responding to queries.
- Manage the regulatory tracking and archive systems.
- Compile documentation of annual regulatory committee reviews, as required, and OHRP federalwide assurances. Remind investigators of upcoming reviews to prevent lapses in approval.
- Ensure distribution and translation of regulatory documents to investigators, as needed.
- In conjunction with GO research Project Managers and investigators, track protocols through all applicable review and approval processes including, but not limited to, IRBs, FDA, and other regulatory agencies. Ensure that all IRB submissions are conducted in an expedient manner.
- Manage the protocol activation process for the GO program, and serve as the contact person for the program investigators and Research Director on the activation process. Track the required documents and activities needed for protocol activation. Perform review of documents for completeness and accuracy. Distribute protocol activation communications allowing enrollment to start once regulatory documents are in place.
- Provide regulatory oversight on safety reporting for the GO projects.
- Design, develop and implement regulatory SOPs to ensure that GO conducts its regulatory activities in accordance with ICH/GCP regulations and guidance documents, as outlined by study sponsors.
- Conduct regulatory trainings, as needed.
- Provide consultation to any GO investigator, collaborator or staff member on regulatory compliance. Coordinate with others, as appropriate, to resolve highly complex or extraordinary regulatory problems that may arise during GO study implementation.
- 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 GO program, and share potential impact that these changes may have on ongoing protocols.
- Liaise with Fred Hutch Office of General Counsel and/or the Office of Tech Transfer, as well as the collaborating/partnering organization(s), in order to create data and material transfer and use agreements (DMTUA) between international and domestic partners.
- Update the master Material Transfer Agreement (MTA) between the Fred Hutch and the Uganda Cancer Institute, as needed.
- Identify potential regulatory risks to the operational plans of the GO program, and propose options to mitigate risks.
- Coordinate / carry out special regulatory projects with minimal oversight.

MINIMUM QUALIFICATIONS
- Minimum Bachelors Degree, advanced degree preferred.
- At least 6 years of experience working within the regulatory environment, including research that is implemented internationally in developing countries.
- Working knowledge of FDA regulations, GCP/ICH and IRB guidelines.
- Knowledge of clinical trial safety issues.
- Excellent written and oral communication skills. Strong organizational skills and attention to detail.
- Good interpersonal skills, and an ability to maintain confidentiality are essential.
- Ability to work independently and pro-actively.

DESIRED QUALIFICATIONS
- Experience in supporting IRB submissions for research that happens in international settings, particularly sub-Saharan Africa.
- Experience working for an IRB/IRO, or serving as an IRB member.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2290093-2647-1921

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