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Florida State University · 1 day ago

Institutional Review Board Post Approval Compliance Specialist

Tallahassee, FL

Full-time

Hybrid

Entry, Mid Level

2+ years exp

Florida State University is one of the nation's elite research universities, and they are seeking an Institutional Review Board Post Approval Compliance Specialist. The role involves performing compliance monitoring audits, coordinating with staff to ensure adherence to research regulations, and providing subject matter expertise to various stakeholders.

EducationUniversities

Responsibilities

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

Qualification

Human Subjects ProtectionFDA Regulatory DeterminationsClinical Practice CertificationCertified Institutional Review Board ProfessionalResearch Compliance CertificationEffective Working RelationshipsProject Deadline ManagementAudit CoordinationResearch RegulationsCritical ThinkingDetail-oriented

Required

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 Human Subjects Protection 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

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