IRB Operations Manager
Sparks Group is in search of a IRB Operations Manager to support a national Medical Center, who will be responsible to provide professional support to their Institutional Review Board. The IRB Manager will be responsible for highly complex duties to facilitate the review and approval process to include determining the appropriate level of review, interpret and apply federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance. This is a direct hire position located in the Washington, D.C. area.
- Conduct protocol pre-reviews.
- Examine all protocol submissions for completeness, accuracy; and internal consistency of the application materials.
- Work directly with investigators to improve the quality of application materials for IRB review.
- Support the IRB in the areas of protocol review, complex correspondence and minutes, event reports, and protocol deviations.
- Apply knowledge of human subject protection regulations and institutional policies to manage IRB meetings and provide consultation/education to investigators and research staff.
- Communicate IRB decisions and rationale to investigators.
- Provide support for IRB procedure manual and forms, training and office management.
- Make recommendation for the appropriate level of IRB review in accordance with federal and institutional codes, rules, and regulations governing biomedical research.
- Conduct initial review and track documents in a comprehensive and time-sensitive manner.
- Use exceptional analytical ability to interpret and apply knowledge of federal regulations and institutional policy to research proposals.
- Exercise skills and knowledge to effectively analyze and solve problems involving highly technical information.
- Provide professional service to the IRB Chair, IRB Committee, and clinical investigators.
- Generate regulatory compliance pre-review; develop meeting agenda and supplemental materials and meeting packets.
- Act as a resource for IRB members regarding regulations and CNMC policies and procedures regarding human subjects.
- Minimum of a Bachelor’s Degree is required, or equivalent work experience in IRB office. Master’s Degree preferred.
- Extensive knowledge of scientific/medical terminology as well as ability to analyze and comprehend research.
- Demonstrated interest in ethics preferred.
- Demonstrated ability to make technical presentations to knowledgeable audiences.
- Ability to handle and maintain confidential information at all times.
- At least 5 years in IRB/research administration, regulatory experience required.
- CIP (Certified IRB Professional) Certification required.
Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!
Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.