SR. CLINICAL RESEARCH COORDINATOR - HYBRID

University of California - Orange, CA

Full-time - Mid Level

Orange, CA

10,001+ employees

Educational Services

About the position

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).

Responsibilities

• Coordinate and manage all aspects of Phase I-IV cancer protocols according to GCP, SOPs, and University policies.
• Assist the Principal Investigator with recruitment, screening, consenting, and patient inquiries during clinic visits.
• Serve as a liaison to sponsors and governing agencies, facilitating communication with national cooperative oncology groups and pharmaceutical companies.
• Maintain communication with a multi-level research network, attending DOTs meetings and interacting with regulatory groups such as the IRB and FDA.
• Provide training and guidance to other clinical research coordinators, demonstrating best practices.
• Analyze internal processes and recommend new policies and procedures to improve operational efficiency.
• Lead and manage pre-study site selection visits, liaising with ancillary medical service units for trial conduct.
• Accurately maintain clinical trial information in the OnCore management system and adhere to reporting guidelines.

Requirements

• 5 to 7 years of related clinical research coordination work experience.
• Bachelor of Arts or Bachelor of Science degree, or equivalent experience.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.

Nice-to-haves

• Experience with cancer-related clinical trials.
• Familiarity with clinical trial management systems.
• Strong problem-solving capabilities and ability to multitask.

Benefits

• Medical insurance
• Sick and vacation time
• Retirement savings plans
• Access to discounts and perks