Job Title: Post-Approval Compliance Manager, Office for Human Subjects Protection
Location: Tallahassee, FL
Regular/Temporary: Regular
Full/Part Time: Full-Time
Job ID: 50271
Department

The Office for Human Subjects Protection, a department within the FSU Office of Research which supports the FSU Institutional Review Board (IRB), seeks to fill the position of Post Approval Compliance Manager.

Equal Employment Opportunity

An Equal Opportunity/Access/Affirmative Action/Pro Disabled & Veteran Employer.

FSU's Equal Opportunity Statement can be accessed at: https://hr.fsu.edu/sites/g/files/upcbnu2186/files/PDF/Publications/diversity/EEO_Statement.pdf.

Responsibilities

This position will develop, implement, maintain and continuously improve a new FSU Institutional Review Board (IRB) post-approval compliance monitoring (PACM) program for ensuring compliance with applicable human research regulatory requirements, to include developing and implementing a PACM strategic plan, policy, standard operating procedures, metrics analyses, audit checklists and worksheets, stakeholder tools and resources, templates, analytics and reporting, and continuous quality improvement.

Responsibilities will include identifying and selecting IRB-approved and exempt studies for PACM audits; routine visit studies will be prioritized based on the Risk Assessment Worksheet score. Focused and directed audits are triggered by PACM requests from reviewing IRBs, study sponsors, external funding and regulatory agencies, human research subjects' complaints, study team members, the OHSP Director, or other FSU leadership.

This position will conduct and/or oversee other staffs' post-approval monitoring review audits to assess and document whether research is being conducted as approved by the IRB and in compliance with all applicable laws and policies pertaining to human subjects protections. Audit activities include scheduling, planning and conducting visits, evaluating study and IRB materials, preparing and disseminating reports of findings, and training researchers as may be necessary. This position will also perform regulatory review of non-exempt human research submissions as an IRB member by applying applicable laws, policies and procedures; documenting all required review and other findings, including IRB determinations; and communicating outcomes or requests for clarification from researchers, study staff and others.

This position must maintain and advance (through situational awareness, education and training) current knowledge of all international, federal and state human subjects protection laws, related policies and SOPs, and ethical guidelines and requirements. Analyze all pertinent developments in the applicable international, federal and state regulatory as well as scientific fields, evaluate impact to the FSU PACM program, and identify courses of action to ensure FSU preparedness and compliance. Other duties as may be assigned related to human subjects protection.

Qualifications Bachelor's degree in human, social or health sciences and four years of human subjects protection experience; or a high school diploma/equivalent and eight years of related experience. (Note: related post-high school education can substitute for some experience at the equivalent rate.)

Documented increasingly advanced human subjects protection responsibilities.Certified Institutional Review Board Professional (CIP) eligibility required upon appointment, with CIP required within one year of appointment.

Preferred

Current CIP and other research compliance-related certification upon appointment.Master’s degree or preparation in a related or scientific discipline.Prior experience in human subjects protection in a higher education and research institution.Prior supervisory experience of human subjects protection staff.

Contact Info For information regarding the position, please contact Brianna Marshall at bcmarshall@fsu.edu.

University Information

One of the nation's elite research universities, Florida State University preserves, expands, and disseminates knowledge in the sciences, technology, arts, humanities, and professions, while embracing a philosophy of learning strongly rooted in the traditions of the liberal arts and critical thinking. Founded in 1851, Florida State University is the oldest continuous site of higher education in Florida. FSU is a community steeped in tradition that fosters research, encourages creativity, and embraces diversity. At FSU, there’s the excitement of being part of a vibrant academic and professional community, surrounded by people whose ideas are shaping tomorrow’s news!

Learn more about our university and campuses.

Anticipated Salary Range

Salary will be commensurate with the selected candidate's education and experience.

Pay Plan

This is an A&P (Administrative and Professional) position.

FSU Total Rewards

FSU offers a robust Total Rewards package. Visit our website to learn more about our Compensation, Benefits, Wellness, Recognition, and Employee Development programs.

Use our interactive tool to calculate Total Compensation options based on potential salary, benefits and retirement contributions, earned leave, and other employment-related perks.

Soft Money Funded Position

This is a soft money funded position, with renewal based on available funds and the needs of the University.

Schedule The schedule for this position is generally Monday – Friday, 8:00am – 5:00pm.

Criminal Background Check

This position requires successful completion of a criminal history background check. The background check will be conducted as authorized and in accordance with University Policy 4-OP-C-7-B11.

How To Apply

If qualified and interested in a specific job opening as advertised, apply to Florida State University at https://jobs.fsu.edu. If you are a current FSU employee, apply via myFSU > Self Service.

Applicants are required to complete the online application with all applicable information. Applications must include all work history up to ten years, and education details even if attaching a resume.

Open until filled

This position will be open until filled. The application review process will begin no later than January 31, 2022.

Tobacco Free Campus

Effective January 1, 2014, tobacco use, including simulated tobacco use, is prohibited on property, interior and exterior, owned or managed by Florida State University. This policy applies to all Florida State University students, employees, consultants, contractors, visitors, and external individuals.