Position Summary:

Rutgers, the State University of New Jersey is seeking a Clinical Research Coordinator III in the department of Medicine – Gastroenterology at the New Jersey Medical School. The Clinical Research Coordinator III will serve as a member of the Clinical Research team. This position is
responsible for coordinating and supporting the regulatory affairs and activities encountered in clinical research trials conducted by the Clinical Research Center. This includes preparation of Institutional Review Board (IRB) applications, responses to funding agencies, regulatory bodies and pharmaceutical partners, & preparing investigator documentation. The CRC III will assist the Clinical Research Team by ensuring adherence to protocols, appropriate regulations, for present and future deadlines.

• Assist with all clinical and regulatory activities for the Clinical Research Center and support the team by establishing priorities for workflow within the Department. The CRC III provides support and oversight to others in the conduct of both clinical and regulatory activities.

• Reviews research proposals/protocols under which human subjects may be involved for conformity to University policy and Institutional Review Board requirements and federal regulations.

• Ensures necessary documentation, i.e., licenses, CVs, 1572, Lab values, CLIA, CAP, and IRB rosters, as well as other required regulatory documents required are on file prior to initiation of any protocol.

• Reviews records with all site visit teams, FDA, NCI or other agents designated by sponsors (especially as related to appropriate consent, proper
  record keeping and quality assurance).

• Collaborates with the CR Team to develop, design and monitor standard operating procedures for regulatory affairs for all clinical protocols.

• Acts as a liaison for investigators and other study staff with sponsor organizations, University Hospital, and pharmaceutical companies, coordinating regulatory aspects of study.

• Assists the CR Team with training of all clinical and non-clinical research staff on Good Clinical Practice guidelines.

Minimum Education and Experience:

• Bachelor's Degree in a Clinical Science or related field required.

• Applicants may substitute additional related experience for the educational requirements on a year-for-year basis.

Required Knowledge, Skills, and Abilities:

• CRC 3 will be trained on Good Clinical Practices (GCP) in addition to some Regulatory Requirements.

• Excellent interpersonal, oral and written communication skills.

• Strong organizational and administrative skills; detail oriented.

• Solid computer skills (Microsoft Word and Excel).

Physical Demands and Work Environment:

• PHYSICAL DEMANDS: Position requires using hands to finger, handle, or feel 2/3 of the time and standing and/walking 1/3 of the time. Possible travel for Investigator
  meetings. Possible travel to community organizations to provide clinical trials education.

• WORK ENVIRONMENT Moderate noise (examples: business office with computers, printers, and light traffic). Must be able to work and cooperate with a broad spectrum of staff and public.

Special Conditions:

• The incumbent’s main focus for this CRC III position will be 75% Clinical & 25% Regulatory Data.

• Able to function independently and work flexible hours including weekends and evenings.

Posting Number: 19ST4148

Location: Newark (RBHS)