Senior IRB Analyst

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
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!Institutional Review Office - Senior IRB Analyst

Purpose:
The Sr. IRB Analyst will prepare compliant and thorough IRB minutes; manage IRB review and external reporting of Noncompliance / Unanticipated Problem / Adverse Event / 3rd Party Safety Reports: and, support the IRB Operations Manager and IRB Analysts for efficient IRB operations. Critical results of this role include:

- Timely creation of consistent, complete and accurate IRB meeting minutes.
- Oversee timely IRB review of reports Noncompliance / Unanticipated Problem / Adverse Event / 3rd Party Safety reports and prepare external agency reports, as required by the IRB
- Document complex regulatory issues and their resolution as they emerge during IRB review. Support the IRB, as required or requested.
- Perform all functions of an IRB Analyst and serve as back-up, as required by the IRB Operations Manager.

Timely creation of consistent, complete and accurate IRB meeting minutes:
- Become familiar with all materials and IRB reviewer comments posted to an IRB meeting prior to the meeting.
- Compose minutes for Full Review meetings, both regularly scheduled and emergency meetings.
- Ensure meeting minutes comply with federal regulations, accreditation standards, and institutional requirements.
- Incorporate IRB result letter text into the minutes, ensuring consistency between minutes text and letter text.
- Route meeting minutes to IRB Operations Manager, and others as specified per the IRB screening form, prior to obtaining Chair signature.
- Assemble minutes and associated material for binding in IRB archives.

Management of IRB review and Federal reporting for Noncompliance / Unanticipated Problem / Adverse Event / 3rd Party Safety reports:
- Review reportable event submissions for completeness and compliance, using screening forms, historical records, and other resources.
- Gather additional data as necessary from researchers, study staff, and others.
- Advise researchers of submission problems and suggest solutions.
- Advise and provide input to IRB Chair and other stakeholders regarding regulation rules and intent, compliance options and regulatory limits.
- Survey reports for patterns and consistency in IRB review.
- Compose and internally route letters reporting IRB determinations to federal agencies such as OHRP and FDA.
- Track reportable events from submission to resolution, including federal reporting and acknowledgement.

Resolution of complex regulatory issues as they emerge during IRB review:
- Work with IRB Analysts and IRB Operations Manager to resolve complex regulatory scenarios posed by IRB submissions within the context of a changing regulatory climate.
- Provide advice to stakeholders (IRO Analysts and Management, IRB Chairs and members, researchers, study staff, and FHCRC colleagues) IRO-related questions and concerns resulting from complex regulatory scenarios.
- Share information with colleagues for group and individual learning within the IRO.
- Evaluate IRB records and IRB files per the IRB Monitoring Policy.

Serve as a back-up for IRB analysts and perform all the functions of an IRB analyst as necessary:
- When necessary for IRB operations, the Senior Analyst may be asked to perform all the duties of an IRB Analyst including:
- Review submissions for completeness and compliance, using screening forms, historical records, and other resources.
- Gather additional data as necessary from researchers, study staff, and others.
- Advise researchers of submission problems and suggest solutions.
- Advise and provide input to IRB Chair and other stakeholders regarding regulation rules and intent, compliance options and regulatory limits.
- Develop agendas for, attend and provide input at monthly and emergency IRO meetings.
- Prepare e-Review agenda for all Full Review items, including cover sheets for hyperlinks, comments, and all other required components.
- Compose and internally route result letters that relay committee requests to investigators.
- Perform reviews of study documents for completeness and consistency across study documents.
- Respond to IRO related questions and concerns initiated by stakeholders.
- Serve as liaison between the IRB and research study staff by exchanging information as part of the day-today processing of submissions.

Minimum Qualifications:
- Bachelor's degree; and either six years Institutional Review/Human Subjects experience OR eight years FHCRC experience in administrative support to research projects/grants; or equivalent combination of education and experience.
- Prior experience as an IRB analyst required.
- Familiarity with FDA regulations and 45 CFR 46 required.
- Must demonstrate organizational and communication skills.
- Attention to detail required.
- Proficient in word processing and previous experience with MS office programs (MS word, Access, Excel) required.
- Certified IRB Professional (CIP) preferred.
- Ability to lift 25 pounds.
- Must be able to read physical documents.

We are a VEVRAA Federal Contractor.

***PLEASE INCLUDE A COVER LETTER WITH SUBMISSION***

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2201387-2647-9221

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