Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Rutgers, the State University of New Jersey is seeking a motivated Clinical Research Associate for the Department of Surgery within the New Jersey Medical School. Under the direct supervision of a transplant surgeon scientist, the Clinical Research Associate will serve as a core member of the translational liver transplant research team of the Division of Transplant and Hepatobiliary Surgery. The Clinical Research Associate is responsible for the planning and coordinating of transplant translational research studies and responsible for patient recruitment based on a set criteria as well as performing consent procedures, coding for confidentiality, documentation of administrative and regulatory requirements, as well as obtaining specimen (blood, tissue samples, etc.) and collecting clinical and laboratory data from hospital databases and clinical records. The Clinical Research Associate will be responsible for ensuring and documenting sample quality in compliance with laboratory SOPs as well as ensuring compliance with instltutional and federal standards and practices.
Among the key duties of this position are the following:
Coordinates the clinical studies for multiple investigators and ensures protocol compliance per the Food and Drug Administration (FDA), Good Clinical Practices (GCP) guidelines, OHRP, HIPAA, IRB and institutional guidelines and standard operating procedures set forth by Rutgers New Jersey Medical School and the Department of Surgery.
Recruits eligible patients for IRB approved studies and carries out consent procedures as well as collects blood or other clinical specimen. Ensures study parameters are correctly applied and eligibility criteria are met.
Documents and files consent documents and ensures coding and confidentiality requirement. Organizes study files, data management procedures and logs. Participates in selected aspects of specimen processing or screening tests.
Coordinates and participates in the analysis of study data. Responsible for the extrapolation, collection, compilation, and. submission of data. This includes, but is not limited to, patient registration, treatment plans, adverse event documentation and reporting, clinical response, and long term follow-up.
Maintains computer databases, as required, for study data and subject lists.
Acts as a liaison for divisional research studies with external and internal offices. Participates in the management of budget issues such as those related to the purchasing of supplies and equipment.
Minimum Education and Experience:
Master's Degree in a clinical research related field plus three (3) years of related clinical research experience, two years (2) of which shall have included university level clinical monitoring.
Required Knowledge, Skills, and Abilities:
Strong research specific knowledge base; knowledge of protocol compliance per the Food and Drug Administration (FDA), Good Clinical Practices (GCP) guidelines, OHRP, HIPAA, IRB and institutional guidelines and standard operating procedures set forth by Rutgers.
Solid knowledge of computer software programs (Microsoft Office, databases, etc.).
Must be detail oriented.
Must have excellent organization, communication, and interpersonal skills.
Must hold one's self accountable to high standards of professional excellence.
Physical Demands and Work Environment:
Must be able to lift or exert force up to twenty-five (25) pounds.
Salary: Maximum authorized amount $86,109
Posting Number: 19ST4923
Location: Newark (RBHS)
Internal Number: 106625
About Rutgers University
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.