Details
Posted: 04-Jan-22
Location: Tallahassee, Florida
Type: Full Time
Preferred Education: Masters
Salary: Commensurate with experience
Sector:
College / University
Salary Details:
Administrative and Professional (A&P). Salary will be commensurate with the selected candidate’s education and experience.
Department
The Office for Human Subjects Protection, a division of the FSU Office of Research which supports the FSU Institutional Review Board (IRB), seeks to fill the position of Post Approval Compliance Manager.
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.
How to Apply
To apply for this position, please submit your application at https://jobs.omni.fsu.edu/psc/sprdhr_er/EMPLOYEE/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=1&JobOpeningId=50271&PostingSeq=1 or go to www.jobs.fsu.edu and search for Job ID # 50271.
Equal Employment Opportunity
FSU is 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.
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.
Application Deadline
This position will be open until filled. The application review process will begin no later than January 31, 2022.
Required
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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.)
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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.
