IRB Coordinator

Job Title: Coordinator II

Location: Cooperman Barnabas Medical Ctr

Department Name: Clinical Research Office

Req #: 0000217753

Status: Salaried

Shift: Day

Pay Range: $65,000.00 - $75,000.00 per year

Pay Transparency:

The above reflects the anticipated annual salary range for this position if hired to work in New Jersey.

The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience.

Job Summary:

Under the supervision of the Manager of the Clinical Research Office, the IRB Coordinator will assist in the overall coordination and compliance of research.

Qualifications:

Required:

• Bachelor's degree in a scientific field or health related field required
• At least three years of experience related to clinical research or research administration
• Knowledge and understanding of IRB regulations and ICH/GCP guidelines.
• Knowledge of state and federal regulations governing the ethical conduct of research and protection of human subjects.
• Excellent verbal and written communication skills.
• Experience with computer applications, particularly proficiency with Microsoft Word, Excel, and PowerPoint.
• Time management skills and ability to prioritize.

Preferred:

• Master's degree preferred
• Comprehensive knowledge of medical terminology preferred
• Experience with IRB/Research Management Systems (e.g. ProIRB, Oncore, or related systems preferred)

Scheduling Requirements:

• FT
• Days

Job Specific Requirements:

• Serves as coordinator of the IRB by coordinating all activities and services in support of the committee and processing all research protocols for appropriate review.

• Analyzes all protocol submissions for completeness and accuracy, recommending the appropriate level of IRB review in accordance with federal and institutional codes, rules and regulations governing biomedical research.

• Drafts correspondence that conveys IRB deliberations and contingencies for approval of research activities involving human subjects.

• Serves as point of contact on IRB-related issues.

• Provides regulatory, ethical, and methodological advice to investigators, staff, and students in preparing applications for research proposals involving human subjects.

• Assists in providing guidance and consultation to IRB members and investigators regarding implementation of regulations, policies, and procedures

• Ensures that all IRB activities and documents are in compliance with OHRP and FDA regulations, including maintaining the institution's Federal Wide Assurance (FWA)

• Distribute and collect annual protocol reviews, conflict of interest forms and follow-up to ensure completion of required information.

• Monitors, analyzes and transmits information to the IRB and investigators on new and/or modified protocols for proper review and conduct of clinical research.

• Assist the IRB Chair with processing of emergency use protocols, and convening special meetings as necessary.

• Maintains IRB tracking/monitoring databases and files.

• Serves as coordinator of the Institutional Research Committee (IRC)

• Coordinates all activities in support of the committee for the feasibility and operational reviews of research protocols.

• Schedules IRC meetings; prepares agendas and distributes meeting minutes, and other related correspondence; including IRC deliberations and contingencies for approvals.

• Attend other research related meetings as requested by Chair and Clinical Research Office

• Attends local and national conferences and seminars to keep abreast of regulatory and legislative requirements related to research.

• Communicate with other system IRB Coordinators on matters of common interest.

• Work cooperatively with other staff in the Clinical Research Office on projects assigned by the Department Head.

• Ensures IRB staff and investigators complete initial human subjects' protection training and periodic refresher courses. (e,g. CITI Trainings)

• Collaborates with system IRB Coordinators towards system-wide integration and harmonization of a centralized IRB and IRC.

• Provides guidance and education to investigator and research staff on IRB policies, procedures, and applicable federal regulations.

• Develops and maintains educational materials (e.g. guides, templates, checklists, FAQs) to promote understanding and ensure compliance with humans subjects research requirements.

• Performs other duties as requested.