Institutional Review Board Post Approval Compliance Specialist

About This Role

This role is responsible for conducting post-approval compliance monitoring audits for IRB-approved studies, ensuring adherence to human subjects protection laws and policies. The specialist will also provide guidance on regulatory requirements and maintain current knowledge in the field.

Responsibilities

• Perform post-approval compliance monitoring audits for select IRB approved and exempt studies
• Coordinate with supervisors and staff in PACM audits to document trends and patterns
• Prepare and disseminate reports of findings and train researchers
• Conduct pre- and post-review of assigned human research and related submissions
• Apply applicable laws, policies, and procedures in reviewing submissions
• Document all required findings and communicate outcomes to researchers
• Provide human research subject matter information to IRB members, researchers, and FSU employees
• Interpret and communicate current regulatory requirements regarding human subjects protection
• Maintain and advance current knowledge of all international, federal, and state human subjects protection laws, policies, SOPs, and ethical guidelines
• Analyze pertinent developments in regulatory and scientific fields to evaluate impact on the FSU PACM program

Requirements

• Bachelor's degree in a human, health or regulatory sciences field and two years of related experience OR a high school diploma or equivalent and six years of Human Subjects Protection experience
• Professional certification such as 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

Qualifications

• Bachelor's degree in a related field (human, health or regulatory sciences) or a high school diploma or equivalent
• 2 years of related experience in Human Subjects Protection, FDA regulatory determinations, or Good Clinical Practice certification; or 6 years of Human Subjects Protection experience with a high school diploma

Nice to Have

• 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
• Experience in research related position
• Ability to work with administrative systems and electronic platforms
• Familiarity with relevant research regulations (e.g. NIH, FDA)
• Familiarity with funded research

Skills

* Required skills

Certifications