Clinical Research Coordinator II
Company: Rutgers University
Location: New Brunswick
Posted on: January 13, 2019
Rutgers, the State University of New Jersey is seeking a Clinical Research Coordinator II (CRC II) for the Clinical Research Unit in the Office of Research at the New Jersey Medical School. The CRC II is responsible for assisting the clinical research team with conducting clinical trials, including, but not limited to, preparing for study initiation and activation, acquisition of source documents, record maintenance, preparing study documents, patient registration, coordinating and data entry. Serves as a study liaison with study sponsors and provides assistance with overall study coordination that is compliant with the Food and Drug Administration (FDA), National Institutes of Health (NIH), Code of Federal Regulations (CFR), Good Clinical Practice (CGP) guidelines, Office of Human Research Protection (OHRP), Health Insurance Portability and Accountability Act (HIPAA), institutional guidelines and standard operating procedures (SOPs) set forth by the New Jersey Medical School.* Coordinates the initiation and activation of all new clinical trial protocols. This includes, but is not limited to verifying Institutional Review Board (IRB) and finance/contract approvals.* Collaborates with other members of the research team to schedule/prepare agendas for pre-activation, initiation and activation meetings.* Develops study tools, including but not limited to eligibility checklists, medication diaries, calendars, and flow sheets (as required).* Actively recruits and screens study subjects. Assists with reviewing subject's medical records for study eligibility.* Works with study subjects and other members of the research team to schedule study visits within appropriate study visit windows.* Assists with maintaining regulatory compliance for assigned studies (i.e. IRB submissions and correspondence, sponsor regulatory binders, etc.)* Provides regular reports to research team members and Principal Investigator on all studies to which he/she is assigned.* Understands and anticipates needs of study sponsors. Serves as study liaison with study sponsors, schedules monitoring visits and conference calls. Provides accurate, timely, thoughtful and concise responses to sponsor queries.* Assists with developing study budgets, as needed.* Monitors subject records for adverse events and informs the research nurse and/or physician of unanticipated events and important medical events.* Maintains up-to-date knowledge and adheres to policies and procedures set forth by Rutgers, NJMS, University Hospital, FDA and all relevant regulatory bodies. Documents and maintains mandatory Rutgers and University Hospital employee requirements such as Blood Born Pathogens, Right-to-Know, Hand-Washing, Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and other institutional requirements.
Keywords: Rutgers University, New Brunswick , Clinical Research Coordinator II, Healthcare , New Brunswick, New Jersey
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