Institutional Review Board Post Approval Compliance Specialist

at  Florida State University

QUALIFICATIONS

Bachelor’s degree in a related field (human, health or regulatory sciences) and two years of related experience (Human Subjects Protection, FDA regulatory determinations, Good Clinical Practice certification, etc.); or a high school diploma or equivalent and six years of HSP experience. (Note: a combination of post high school education and experience equal to six years.)
Professional certification such as Certified Institutional Review Board Professional (CIP) eligibility or other research compliance certification (e.g. ACRP, SOCRA) required or in process upon appointment, to be completed within 1 year of hire.

PREFERRED QUALIFICATIONS

• Ability to adhere to ethical business practices and promote ethical behavior.
• Ability to establish and maintain effective working relationships.
• Ability to meet project deadlines.
• Ability to prepare, coordinate, and conduct audits.
• Ability to demonstrate critical thinking based upon in-depth data, substantiating information, considering, and respecting others’ input personal values, and ethics.
• Ability to perform accurately in a detail-oriented environment.
• Qualified candidates will have experience in research related position. Candidates will have the ability to work with administrative systems and electronic platforms, be familiar with relevant research regulations (e.g. NIH, FDA) and possess familiarity with funded research.

Perform post-approval compliance monitoring (PACM) audits for select IRB approved and exempt studies; selected studies and audits 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.
Coordinate with supervisors and other staff in PACM audits to document trends and patterns about whether research is being conducted as approved by the IRB and in compliance with all applicable laws and policies pertaining to human subjects protections. Activities include preparing and disseminating reports of findings, and training researchers as may be necessary.
Conduct pre- and post-review of assigned human research and related submissions by applying applicable laws, policies and procedures; documenting all required and other findings; and communicating outcomes or need for clarification from researchers and study staff.
Provide human research subject matter information to Institutional Review Board (IRB) members, researchers and study staff and FSU employees by interpreting and communicating current regulatory requirements; assisting with completion of human research submission materials and use of the electronic protocol management system (RAMP IRB); and referral to related guidance, templates, information and other resources.
Maintain and advance through situational awareness, educational 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.