Recruitment/Posting Title Clinical Research Coordinator III
Job Category Staff & Executive - Research (Laboratory/Non-Laboratory)
New Jerseys 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 UniversityNew Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and six centers and institutes that focus on cancer treatment and research, neuroscience, clinical and translational research, 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 including New Brunswick, Piscataway, Newark, Scotch Plains, Somerset, Blackwood, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, 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.
Rutgers, the State University of New Jersey is seeking a highly motivated Clinical Research Coordinator III (CRC III) 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 CRC III 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 CRC III 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 patients rights, interests and well-being through efforts to comply with the Food and Drug Administration (FDA) and IRB policies and procedures.
Position Status Full Time
Hours Per Week
Daily Work Shift Rotating
Position Salary Maximum authorized hiring salary amount $43,932.00
Annual Minimum Salary 43932.000
Annual Mid Range Salary 52804.500
Annual Maximum Salary 61677.000
Standard Hours 37.50
Union Description HPAE, Local 5094
Payroll Designation PeopleSoft
Information about the benefits provided to Rutgers employees can be found at: http://uhr.rutgers.edu/benefits/benefits-overview
Terms of Appointment Staff - 12 month
Position Pension Eligibility ABP
Minimum Education and Experience
- Bachelors 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 III 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).
- Masters 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
- Possible travel to community organizations to provide clinical trials education.
Posting Number 19ST2890
Posting Open Date
Special Instructions to Applicants
Regional Campus Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus Newark (RBHS)
All offers of employment are contingent upon successful completion of all pre-employment screenings.