Job Summary:
Coordinates the daily activities of the Institutional Review Board (IRB) process for human subject research. Reviews and analyzes protocol applications and participates in conducting ORI compliance education/outreach activities for faculty, staff and students.
- Coordinates the activities of the Social and Behavioral Institutional Review Board (SB-IRB) and the Health Sciences Institutional Review Board (HS-IRB)
- Assists in the development, implementation and maintenance of SOPs, educational materials, and associated forms and policies.
- Assists with protocol submissions requiring WCG IRB approval, single IRB review, and IRB reliance requests.
- Reviews new protocol submissions, continuing reviews, amendments, and informed consent forms to ensure accordance with OHRP/FDA regulations.
- Assists with post approval monitoring of protocols.
Coordinates the IRB review workflow and assigns protocols to board members for review. - Provides investigators with guidance on the IRB submission process and contacts investigators for additional information as needed.
- Updates IRB committee members on new federal regulation developments and the appropriateness of review procedures.
- Records meeting minutes of convened committee meetings.
- Updates and maintains protocols through the online IRB protocol submission system.
- Participates in conducting ORI compliance education/outreach activities for IRB committee members, faculty, staff and students.
- Processes and/or drafts approval letters for initial, amendment, renewal and event report form submissions.
Minimum Qualifications:
- Bachelor’s degree and two (2) years of relevant experience.
Desired Qualifications:
- IRB, auditing, managing clinical trials and/or QA/QI experience.
- Experience in a clinical research environment.
- Working knowledge of OHRP and FDA regulations.
How to Apply:
For further information or to apply, please visit careers.fiu.edu and reference Job Opening ID #533237