IRB Exempt Determination Officer, Human Subjects Protection

Location: Remote

Regular/Temporary: Regular

Full/Part Time: Full-Time

Job ID: 62178

Department

Human Subjects Protection within the Office of Research, seeks to fill the Exempt Determination Officer position.

Responsibilities

This role manages the regulatory support program by developing and managing human research outreach, consultation and Institutional Review Board (IRB) pre-submission guidance services for faculty and their related funding applications and awards, including supervising the Regulatory Support Specialist position (i.e., directing day to day activities, ensuring appropriate training and expertise to carry out responsibilities, providing guidance on complex situations, conducting performance reviews, etc.).

Is responsible for maintaining, evaluating and continuously improving FSU policies, procedures, and related materials for an IRB exemption program to ensure adherence with applicable human research regulatory requirements and guidance for related functions and operations, including written procedures and reporting as well as regulatory records (45 Code of Federal Regulations, sections 103-104, 108 and 115).

Is responsible for identifying and evaluating, using related business analytics and electronic protocol management systems (e.g., RAMP) metrics, continuous improvements to submission workflows to ensure timely, complete and appropriate triaging and reviews for research that qualify for exemption from IRB oversight or limited IRB review.

Triage and perform regulatory and ethics reviews of research submissions that qualify for exemption from IRB oversight or limited IRB review, including communicating to researchers any required modifications or clarifications and review outcomes, as well as documenting all regulatory determinations.

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 program and in the applicable international, federal and state regulatory as well as scientific fields, evaluate impact to the FSU Post-Approval Compliance Monitoring (PACM) program, and identify courses of action to ensure FSU preparedness and compliance.

Assist the Director in conducting regulatory pre- and post-Limited IRB review of exempt human research submissions by applying applicable laws, policies and procedures; assisting IRB members in their Limited IRB reviews; and communicating outcomes or requests for clarification from researchers, study staff and others. Other duties as assigned related to human subjects protection.

Qualifications

Bachelor's degree and four years of experience in human subjects protection or regulatory determinations; or high school diploma/equivalent and experience equal to eight years. (Note: post-high school education can substitute for experience at the equivalent rate.)

Preferred Qualifications

• Bachelor's degree in a related field (human, social or health sciences).
• Experience with regulatory determinations.
• Ability to adhere to ethical business practices and promote ethical behavior.
• Ability to demonstrate critical thinking based upon in-depth data, substantiating information, considering, and respecting others' input, personal values, and ethics.
• Ability to establish and maintain effective working relationships, and effectively train and direct the work of others.
• Ability to meet project deadlines.
• Ability to perform accurately in a detail-oriented environment.
• Ability to develop and implement policies, procedures, goals, and objectives.
• Ability to conduct audits and investigations.
• Ability to document existing and new processes.

This is an A&P position.

This position requires successful completion of a criminal history background check.

This position is eligible for remote work.