Chair convened meetings of the IRB and ensure reviews are conducted and determinations are made in accordance with guiding ethical principles, in compliance with applicable regulations, laws, policies, and procedures.
Maintain a current knowledge of relevant regulations and guidelines, including DHHS, FDA, ICH-GCP, HIPAA, Conflict of Interest, and NIH Guidelines.
Regularly consult with Director of IRB Operations, Director of Regulatory, IRB Chair, and IRB Staff regarding IRB issues.
Ensure quorum is present and maintained at IRB meetings.
Ensure adequate expertise is present at convened meetings for IRB review and determinations.
Facilitate the discussion, deliberation, and vote of protocol reviews; bring controverted issues to resolution respectfully and efficiently.
Review the minutes of convened meetings to ensure they accurately reflect IRB meeting activities and determinations.
Support the timely and accurate communication of IRB determinations to investigators.
Assist with recruitment, training, evaluation, and retention of IRB members.
Serve as a Designated reviewer using expedited review procedures.
Assist in the development and implementation of IRB policies and procedures.
Suspend IRB approval of research activities outside of an IRB meeting in exceptional cases where, based on professional judgement, immediate action should be taken until the matter can be undertaken at the next convened IRB meeting.
Assist with investigations and review of alleged noncompliance.
Perform other duties as assigned.
Master’s degree required, with terminal degree preferred, such as PhD, MD, JD, or PharmD.
Proven experience in serving as a Chair or Committee member of an Institutional Review Board.
Preference given to candidates with prior IRB Chair experience.
Knowledgeable in applicable regulations and guidelines, including DHHS, FDA, ICH-GCP, and HIPAA.
Knowledgeable in research methods, clinical trial design, and good clinical practice.
Ability to work both independently and collaboratively in a team structure and thrive in a fast-paced environment.
Superb organizational and communication skills, both written and oral skills, and “do-what-it-takes” attitude.
Independently motivated, good problem-solving ability, and excellent judgment.
Personable, flexible, diplomatic, and reasonable, ability to adapt to changing priorities.
Strong attention to detail and multi-tasking ability.
Excellent computer and documentation skills and an ability to prioritize effectively.