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Coordinates the activities of the Social and Behavioral Institutional Review Board (SB-IRB) and the Health Sciences Institutional Review Board (HS-IRB) as well as reviewing, updating, and maintaining IRB submission protocol.
Coordinates the activities of the Social and Behavioral Institutional Review Board (SB-IRB) and the Health Sciences Institutional Review Board (HS-IRB).
Reviews new protocol submissions, continuing reviews, amendments, and informed consent forms for completeness in accordance with OHRP/FDA regulations.
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.
Maintains and records appropriate IRB documentation of convened board meeting decision making.
Updates and maintains protocols through the online IRB protocol submission system.
Participates in compliance education/outreach activities for IRB committee members, faculty, staff and students.
Manages and reviews data and safety monitoring plans, adverse event reports, protocol deviations, and corrective action reports.
Assists with protocol submissions that require WCG IRB review and approval.
Assists with post-approval monitoring of IRB protocols.
Minimum Qualifications:
Bachelor's degree and two (2) years of relevant experience.
Desired Qualifications:
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 is preferred.
Proactive individual who functions independently.
Excellent written and oral communication skills.
Highly organized, with advanced attention to detail and strong multi-tasking skills.
To obtain a paper copy of the report, please visit the FIU Police Department located at 885 SW 109th Avenue, Miami, FL, 33199 (PG5 Market Station).
Pay Transparency
Florida International University will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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, sexual orientation, gender identity, national origin, disability or protected veteran status.
