University of California - Orange, CA
posted 5 months ago
The Assistant Research Data Coordinator (ARDC) plays a crucial 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, the ARDC is responsible for comprehensive data management for a portfolio of Phase I-IV cancer-related protocols, ensuring adherence to Good Clinical Practices (GCP), internal standard operating procedures (SOPs), and university policies. This position requires the timely and accurate collection and coordination of data submissions to study sponsors, which is essential for maintaining quality control and facilitating timely milestone payments. The ARDC will compile and transcribe research patient data and study-related information into case report forms (CRFs) and sponsor-specific electronic data capture systems (EDC). In addition to data management, the ARDC will collaborate with the clinical research team to ensure accurate data collection and assist Principal Investigators and study coordinators with all data management aspects of cancer-related trials. The role also involves serving as a liaison to sponsors and governing agencies, facilitating communication with national cooperative oncology groups, pharmaceutical companies, and other research entities. The incumbent will maintain communication with various elements of a multi-level research network, interacting with sponsoring agencies such as the National Cancer Institute, and compliance and regulatory groups like the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). The ARDC must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI). The position requires strong problem-solving capabilities, high-level communication skills, and the ability to work both independently and as part of a team. The ARDC will also need to demonstrate a commitment to maintaining confidentiality and integrity while managing sensitive patient data.