Rutgers, The State University of New Jersey is seeking a Program Development Analyst within the Rutgers Cancer Institute of New Jersey. The Program Development Analyst under the direct supervision of the Manager of Clinical Trials Regulatory Affairs will manage the regulatory activities of the Office of Human Research Services (OHRS). These activities include, but may not be limited to preparation of documents for submission to the Institutional Review Board (IRB), Investigational New Drug (IND) preparation and maintenance, submissions of letters of intent and protocols to be submitted to the National Cancer Institute or pharmaceutical sponsors. The Program Development Analyst will manage and maintain regulatory documents for Cancer Institute of New Jersey investigator initiated, national cooperative group and industry trials. This position will assist in developing and maintaining Standard Operating Procedures (SOPs) that comply with all pertinent regulations to ensure the accuracy and timely of all protocols, consent forms, amendments, annual re-approvals, serious adverse events, and IND safety reports to the IRB.
Among the key duties for this position are the following:
Collects, completes and submits regulatory documentation to various regulatory entities such as Cancer Trials Support Unit (CTSU) for national oncology group protocols.
Reviews quality assurance reports of audits at clinical trial participating sites and follow up on regulatory issues identified. Provides appropriate education regarding any deficiencies.
Works with management to develop and implement administrative policies and procedures that support the efficient coordination of new Cancer Institute of New Jersey research protocols from conception through closure and termination, accrual, and payment.
Assists with training, orientation and precepting of new Cancer Institute, Regulatory personnel.
Verifies contract completion between sponsor, investigators, and the Cancer Institute for all clinical trials conducted in the Cancer Institute and the Statewide Network.
Verifies accrual for non-therapeutic trials and updates Oncore as appropriate.
Minimum Education and Experience:
Bachelor's Degree plus (3) years' experience in clinical research regulatory affairs required.
Equivalent experience, education and/or training may be substituted for the education requirements.
City: New Brunswick
Physical Demands and Work Environment:
PHYSICALDEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs.
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.