Sr. Clinical Research Coordinator

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Under the supervision of the Lab Research Manager (LRM), the Senior Clinical Research Coordinator (SCRC) supports the clinical research efforts of the Department of Orthopaedic Surgery by providing comprehensive coordination and data management for complicated Phase I‑IV protocols according to Good Clinical Practices (GCP), internal SOPs, and university policies and procedures.

The incumbent is responsible for supporting and coordinating all aspects of the clinical research for protocol‑specific requirements, research procedures, chart preparation, data collection, and record keeping. The incumbent will prepare study IRB applications and maintain regulatory compliance. Attends clinic to assist the Principal Investigator (PI) and other research personnel with recruitment, screening, consenting, administering questionnaires, answering patient research questions, scheduling appointments, etc.

Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of multi‑level research networks, including attending meetings, interacting with sponsoring agencies such as National Institute of Health, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The incumbent is responsible, under the direction of the LRM, to provide training and guidance to other clinical research personnel and trainees, demonstrating best practices, and providing ongoing analysis of internal processes and recommending new policies and procedures to improve overall operational efficiency and customer service.

The incumbent is responsible, under the direction of the LRM, for leading and managing pre‑study site selection visits (PSSVs) including liaising with all appropriate ancillary medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial for the assigned disease area.

In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external grant guidelines for reporting to the National Institute of Health (NIH).

Required:

• Ability to interact with the public, faculty and staff.
• Ability to establish and maintain files and records.
• Demonstrated high‑level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others.
• Demonstrated problem‑solving capabilities to resolve concerns that arise unexpectedly.
• Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence.
• Demonstrated ability to organize and prioritize a complex and dynamic workload.
• Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds.
• Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and/or in environments with frequent workload changes and competing demands.
• Skill in working independently, taking initiative and following through on assignments.
• Ability to think critically, compile data from…