IRB Coordinator II
4 days ago
The IRB Coordinator II is a critical role within the Orlando Health organization, responsible for ensuring the highest standards of regulatory compliance and research integrity. This position plays a key part in the review and approval process of proposed documentation for research activities involving human subjects, protecting their safety, rights, and welfare.
Key Responsibilities- Prepare and maintain documentation for regulatory submissions, including but not limited to, study forms, safety and deviation reports, and educational materials.
- Lead the review of study-specific documentation and process of a moderate nature, ensuring compliance with regulatory guidelines.
- Prepare and submit reviews of protocols, determining whether they meet regulatory requirements.
- Maintain reviews of research submissions received from researchers within the Orlando Health hospital system using the IRBNet system.
- Prepare study documentation for long-term storage and ensure compliance with regulatory requirements.
- Prepare for internal/external audits of regulatory records and provide guidance to less experienced staff.
- Liaise between the Principal Investigator, IRB members, corporate research, funding entities, and ancillary review committees.
- Respond to and resolve queries from all research departments of Orlando Health, ensuring timely and effective communication.
- Respect diversity by building respectful relationships with all team members, investigators, sponsors, and regulatory authorities.
- Assess and evaluate trial progress for study renewals, closures, deviations, and other events, issuing queries requesting additional information and revisions to IRB submissions.
- Report on trial progress and ensure compliance with regulatory requirements.
- Demonstrate competency in regulatory knowledge and practices effective problem identification and resolution.
- Serve as a preceptor, mentor for staff and/or departmental educator presenting IRB informational sessions to provide education regarding submitting research projects to the Orlando Health IRBs.
- Function as a departmental advocate and assist with quality assurance activities for IRB board and in research departments.
- Responsible for the preparation of submissions for review by the IRB Pre-Review Committee and/or final review by the Institutional Review Board (IRB) Manager and/or IRB Chairpersons.
- Coordinate submissions for expanded access treatment uses, such as Single Patient IND, compassionate uses, etc.
- Bachelor's degree required.
- Eligibility for Certified IRB Professional (PRIM&R), OR Certified IRB Manager (CIM) OR Certified Clinical Research Professional (SoCRA) OR Certified Clinical Research Coordinator (ACRP) certification.
- Four (4) years of IRB, clinical research, or other directly related experience.
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