Job Description
IRB Coordinator Consultant at Vitalief summary:
The IRB Coordinator Consultant supports a hospital research center by managing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional human subjects research regulations. Responsibilities include reviewing research protocols, coordinating IRB meetings, maintaining regulatory compliance, and providing guidance to investigators and IRB members. The role requires clinical research experience, strong organizational skills, and knowledge of regulatory frameworks such as OHRP, FDA, and ICH/GCP.
About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably.
The Role We are seeking an experienced IRB Coordinator Consultant to join the Vitalief team as a contractor. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities.
Engagement Details - Work Hours: 40 hours per week (8am to 4pm M-F)
- Work Location: 100% on-site in Livingston, NJ.
- Contract Duration: 6 months (possible extension)
- Pay Rate: Market competitive (depends on experience level)
Responsibilities: - Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications.
- Review protocol submissions for completeness and accuracy; recommend appropriate level of review.
- Draft and issue correspondence reflecting IRB deliberations and decisions.
- Provide regulatory and methodological guidance to investigators, staff, students, and IRB members.
- Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations.
- Manage IRB databases, tracking systems, and protocol documentation.
- Assist with emergency use protocols and special meetings as needed.
- Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items.
- Collaborate with other system IRB Coordinators and departmental staff.
- Stay current on regulatory and legislative developments through conferences and professional training.
Qualifications: - Bachelor's degree in a scientific or health-related field required; Master's degree preferred.
- Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience.
- Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines.
- Excellent written and verbal communication skills.
- Ability to demonstrate professionalism, clear communication, and respect in all interactions.
- Passionate in supporting teamwork and collaborative problem-solving.
- Apply continuous quality improvement principles to research operations.
- Work independently with accountability, sound judgment, and openness to feedback.
- Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects.
- Detail-oriented with strong organizational and follow-up skills.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred.
- Certified IRB Professional (CIP®) is a plus.
- Knowledge of medical terminology preferred.
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Keywords:
IRB coordination, clinical research compliance, human subjects research, protocol review, regulatory guidance, research administration, FDA compliance, OHRP regulations, ICH/GCP guidelines, research ethics
Job Tags
Full time, Contract work, For contractors, Work at office,