Rutgers, the State University of New Jersey is seeking a highly motivated Clinical Research Coordinator III (CRCIII) for the Department of Medicine Gastroenterology/Hepatalogy/Liver Transplant Program 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 CRCIII will assist the Clinical Research Team by ensuring adherence to protocols, appropriate regulations, for present and future deadlines.
Assists with all regulatory activities for the Clinical Research Center and support the team by establishing priorities for workflow within the Department. The CRCIII provides support and oversight to others in the conduct of 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.
Coordinates the protocol approval process with Committees.
Communicates and coordinates with research investigators, monitors, IRB, and sponsors on requests for additional information and/or supportive documentation.
Composes and submits Investigational new Drug Applications to the FDA for drugs needing FDA approval.
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.
Maintains current knowledge of protocols, eligibility requirements, and amendments. Prepares and coordinates IRB submissions of protocol amendments, revisions, annual reports as required.
Maintains excellent working relationships with IRB staff. Serves as an educational resource on research compliance for Investigators and the Clinical Research Team.
Assists investigators in assuring compliance to protocol requirements; suggests improved methods for accomplishing.
Acts as a liaison for investigators and other study staff with sponsor organization and pharmaceutical companies coordinating regulatory aspects of study.
Collaborates with the CR Team to develop, design and monitor standard operating procedures for regulatory affairs for all clinical protocols.
Assists the CR Team with training of all clinical and non-clinical research staff on Good Clinical Practice guidelines.
Attends and participates in staff meetings.
Serves as a departmental resource for inquires on the research 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).
Strictly adheres to policies and procedures to ensure the protection of patient's rights, interests and well-being through efforts to comply with the Food and Drug Administration (FDA) and IRB policies and procedures.
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:
CRCIII will be trained on Regulatory Requirements, & Good Clinical Practices (GCP).
Excellent interpersonal, oral and written communication skills.
Strong organizational and administrative skills; detail oriented.
Solid computer skills (Microsoft Word and Excel).
Master's Degree in Clinical Science or related field preferred.
Physical Demands and Work Environment:
Position requires using hands to finger, handle, or feel 2/3 of the time and standing and/walking 1/3 of the time.
Able to function independently and work flexible hours including weekends and evenings.
Possible travel for Investigator meetings.
Possible travel to community organizations to provide clinical trials education.
Salary: Maximum authorized hiring salary amount $43,932.00
Posting Number: 19ST2890
Location: Newark (RBHS)
Internal Number: 93755
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.