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Research Compliance Officer
2 months ago
The IRB Coordinator II is a key member of the research compliance team at Orlando Health, responsible for ensuring the integrity and quality of research studies involving human subjects. This role requires a strong understanding of regulatory guidelines and the ability to apply them in a practical setting.
Key Responsibilities- Review and approve research protocols to ensure compliance with regulatory requirements, including those of the FDA, OHRP, and NIH.
- Manage the review process for research submissions, including the preparation of documentation and the coordination of internal and external audits.
- Provide guidance and support to researchers and staff on regulatory requirements and research compliance.
- Collaborate with the Principal Investigator, IRB members, and other stakeholders to ensure the successful conduct of research studies.
- Assess and evaluate trial progress, identifying and resolving any issues that may impact the integrity of the research.
- Prepare and maintain documentation for regulatory submissions, including study protocols, informed consent forms, and other relevant documents.
- Coordinate 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.
- Participate in the development and implementation of research compliance policies and procedures.
- Bachelor's degree required.
- Four (4) years of experience in IRB, clinical research, or a related field.
- Eligibility for certification as a Certified IRB Professional (PRIM&R), Certified IRB Manager (CIM), Certified Clinical Research Professional (SoCRA), or Certified Clinical Research Coordinator (ACRP).
