Clinical Research Associate
- Rutgers Biomedical Health Sciences- New Jersey Medical School
- Location: Newark, NJ
- Job Number: 7062644
- Posting Date: Dec 9, 2019
- Application Deadline: Open Until Filled
Job DescriptionUnder 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. Responsible for the planning and coordinating of transplant translational research studies. Responsible for patient recruitment based on 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. Participate in preparing and renewing IRB protocols and maintain other regulatory and compliance requirements set by applicable Government and Industrial agencies, The University Hospital and Rutgers New Jersey Medical School. Laboratory responsibilities will include the processing and cryopreservation of human blood and tissue samples collected in clinic and operative settings. The clinical research associate will be responsible for ensuring and documenting sample quality in compliance with laboratory SOPs as well as ensuring compliance with intuitional and federal standards and practices.
1. 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.
2. Recruits eligible patients for IRB approved studies and carry out consent procedures as well as collect blood or other clinical specimen. Ensures study parameters are correctly applied and eligibility criteria are met.
3. 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.
4. 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.
5. Maintains computer databases as required for study data and subject lists.
6. 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.