Institutional Review Board Compliance Manager

Responsibilities

• Aid in the development and implementation of human research protection for all NTR IRB partners.
• Conduct comprehensive administrative and regulatory reviews of IRB submissions to ensure they meet federal agency regulatory requirements.
• Provide ongoing education and training to researchers to ensure compliance with federal, state, and institutional policies and regulations.
• Prepare documents for review by the IRB Committee and follow up with researchers on necessary information.
• Oversee, attend, and coordinate IRB committee meetings, communicating outcomes to investigators and relevant institutional officials.
• Develop and implement in-house compliance training programs and educational materials.

Requirements

• Bachelor's degree and four (4) years related experience; or equivalent combination of education and experience.
• Thorough knowledge of appropriate federal regulatory agencies (FDA, OHRP).
• Strong organizational and analytical skills; excellent attention to detail; and objective observer.
• Exceptional written, verbal, and presentation skills.
• Experience with critical thinking, project management, document management, and client interactions.

Qualifications

• Bachelor's degree in any health sciences field, Masters Degree preferred.
• Three (3) years human subject research experience or three (3) years in an IRB-related role.
• Certified IRB Professional (CIP) Certification or eligibility for such certification.

Benefits

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