University of California - Orange, CA
posted about 2 months ago
The Senior Clinical Research Coordinator (SCRC) plays a pivotal role in supporting the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC) at UC Irvine. Under the supervision of the Clinical Research Manager (CRM), the SCRC is responsible for the comprehensive coordination and data management of complex Phase I-IV cancer protocols, ensuring adherence to Good Clinical Practices (GCP), internal standard operating procedures (SOPs), and University policies. This position involves managing all aspects of cancer-related trials, including protocol-specific requirements, research procedures, data collection, and meticulous record-keeping. The SCRC will attend clinics to assist the Principal Investigator (PI) with various tasks such as recruitment, screening, consenting, administering questionnaires, and addressing research patient inquiries. Additionally, the SCRC will schedule appointments and serve as a liaison to sponsors and governing agencies, facilitating communication with national cooperative oncology groups, pharmaceutical companies, and other research entities as necessary. The SCRC is also tasked with maintaining communication across a multi-level research network, which includes attending Disease Oriented Teams (DOTs) meetings and interacting with sponsoring agencies like the National Cancer Institute, as well as compliance and regulatory groups such as the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). Under the CRM's guidance, the SCRC will provide training and mentorship to other clinical research coordinators, demonstrating best practices and analyzing internal processes to recommend improvements for operational efficiency and customer service. Furthermore, the SCRC will lead and manage pre-study site selection visits (PSSVs), coordinating with ancillary medical service units for the successful conduct of trials in the assigned disease area. The role requires accurate maintenance of clinical trial information in the clinical trial management system (OnCore) and compliance with institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).