Florida International University is Miami’s public research university, focused on student success. According to U.S. News and World Report, FIU has 42 top-50 rankings in the nation among public universities. FIU is a top U.S. research university (R1), with more than $200 million in annual expenditures. FIU ranks 15th in the nation among public universities for patent production, which drives innovation, and is one of the institutions that helps make Florida the top state for higher education. The Next Horizon fundraising campaign is furthering FIU’s commitment to providing students Worlds Ahead opportunities. Today, FIU has two campuses and multiple centers, and supports artistic and cultural engagement through its three museums: Patricia & Phillip Frost Art Museum, the Wolfsonian-FIU, and the Jewish Museum of Florida-FIU. FIU is a member of Conference USA, with more than 400 student-athletes participating in 18 sports. The university has awarded more than 330,000 degrees to many leaders in South Florida and beyond. For more information about FIU, visit www.fiu.edu.
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.
Performs other related duties required or as directed. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Bachelor's degree and two (2) years of relevant experience.
A certification as a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Certified IRB Manager (CIM), or Certified IRB Professional (CIP) is preferred.
Excellent working knowledge of OHRP and FDA regulations.
Proactive individual who functions independently.
Excellent written and oral communication skills.
Highly organized with advanced attention to detail and strong multi-tasking skills.
Demonstrated ability to interact on a professional level with faculty, staff and students.
$50,000 - $55,000
Begin time: 8:30 AM
End time: 5:00 PM
Criminal Background Check
FIU is a member of the State University System of Florida and an Equal Opportunity, Equal Access Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
For further information or to apply online visit our website at careers.fiu.edu and reference job opening ID # 524626