Careers

IRB Coordinator - 528467

Job Summary:

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.
• IRB, auditing, managing clinical trials and/or QA/QI experience preferred.

 Job Category:
Administrative

Advertised Salary:

$50,000 - $60,000

Work Schedule:

• Begin time: 8:30 AM
• End time: 5:00 PM

Pre-Employment Requirements:
Extended Criminal Background Check

For further information or to apply, please visit careers.fiu.edu and reference Job Opening ID # 527966

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