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. |
Posting Summary |
Rutgers, The State University of New Jersey, is seeking a Research Study Manager – Clinical Trials for the department of Medicine at the Robert Wood Johnson Medical School.
The Clinical Trials Research Study Manager, under the direct supervision of the Research Director of the Division, will assist in activities to support and grow the Clinical Research – driven by innovation and digital transformation – in the Division. These activities include, but may not be limited to supporting lab testing, including setup, processing and shipping, ordering of supplies, developing source documents, data entry, record maintenance and archiving, study visit tracking, assisting with budget preparation and registration of study subjects. IRB submission and maintaining compliance with IRB, HIPAA, and FERPA guidelines, and engaging scientifically in grant applications.
Among the key duties of this position are the following:
- Work closely with supervising research director and principal investigator(s) to develop protocols for clinical research proposals, organize research activities and maintain effective communication between project staff, external collaborators, funding agencies, and regulatory entities.
- Oversees research activities to achieve study timelines and quality execution.
- Providing proactive leadership and oversee all aspects of research operations.
- Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results.
- Support the development of publishable materials relating to the clinical research (Manuscript submission, abstracts, study presentations).
- Developing both short-term and long-term plans for growth and expansion of existing services; as well as, for the introduction of new programs.
- Assure compliance of general and study specific regulatory related processes with ICH, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies. Maintain primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate committees and Institutional Review Board, maintain annual IRB approvals, amendments, and safety events, process data queries and ensure resolution, maintain essential staff documents (CVs, licenses, site laboratory certifications).
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