Clinical Research Coordinator III

Rutgers University • Newark, NJ

3d

About The Position

Rutgers, The State University of New Jersey is seeking a Clinical Research Coordinator III ( CRC III ) for the Department of Medicine-Infectious Diseases within 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 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, and present and future deadlines. Among the key duties of this position are the following: Assist with all 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 regulatory activities. Review research proposals/protocols under which human subjects may be involved for conformity to University policy and Institutional Review Board requirements and federal regulations. Coordinate the protocol approval process with Committees. Compose and submit 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. Overview New Jersey’s academic health center, Rutgers Biomedical and Health Sciences ( RBHS ) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health. Aligned with Rutgers University–New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Our faculty are teachers, clinicians, and scientists with unparalleled experience who advance medical innovation and provide patient care informed by the latest research findings. We offer an outstanding education in medicine, dentistry, pharmacy, public health, nursing, biomedical research, and the full spectrum of allied health careers. Our clinical and academic facilities are located throughout the state—at Rutgers University–New Brunswick, including Piscataway; and at locations in Newark, Scotch Plains, Somerset, Stratford, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark’s University Hospital in Newark, and other affiliates. Through this community of healers, scientists, and scholars, Rutgers is equipped as never before to transform lives. Rutgers RBHS is an anchor institution that boasts locations in Newark, New Jersey, a city of promise.

Nice To Haves

• 2 years of research-related experience.
• Master’s Degree in Clinical Science or related field.

Responsibilities

• Assist with all 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 regulatory activities.
• Review research proposals/protocols under which human subjects may be involved for conformity to University policy and Institutional Review Board requirements and federal regulations.
• Coordinate the protocol approval process with Committees.
• Compose and submit 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees