Sr. Clinical Research Coordinator

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs.

It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.
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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 standard operating procedures (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.

• Prepares study IRB applications and maintains regulatory compliance.
• Attends clinics to assist the Principal Investigator and other research personnel with recruitment, screening, consenting, administering questionnaires, answering patient research questions, and scheduling appointments.
• Serves as the liaison to sponsors, governing agencies and facilitates transmission of communication to national cooperative oncology groups, pharmaceutical companies and other research entities.
• Maintains communication with all elements of multi‑level research networks, including attending meetings, interacting with sponsoring agencies such as the National Institute of Health, and compliance and regulatory groups such as the Institutional Review Board, FDA, and sponsor monitors.
• Provides training and guidance to other clinical research personnel and trainees, demonstrates best practices, and conducts ongoing analysis of internal processes to recommend new policies and procedures to improve operational efficiency and customer service.
• Leads and manages pre‑study site selection visits (PSSVs), liaising with all appropriate ancillary medical service units (e.g., Investigational Drug Service, Pathology, Radiology) for the conduct of the trial for the assigned disease area.
• Maintains clinical trial information in OnCore and adheres to institutional policies and external grant guidelines for reporting to NIH.

• Analogous to the responsibilities above, demonstrated high‑level communication skills to convey information clearly and concisely.
• Experience in maintaining files and records, research, evaluating information, and preparing concise, well‑organized reports, summaries, and correspondence.
• Ability to organize and prioritize a complex and dynamic workload and work independently or as part of a team.
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Knowledge of human subject clinical trials (National Group, industrial, investigator‑authored).
• Bachelor's degree in a related area and/or equivalent experience/training.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
• At least 2 years of related clinical research coordination experience.
• Track record of human subjects research (Phase I–III drug trials, device trials) coordination, informed consent procedures and IRB submission.
• Experience working in a medical/clinical setting and familiarity with medical terminology.

• Current nationally‑recognized clinical research coordinator certification (SOCRA, ACRP, etc.).
• Experience with clinical trial management systems, preferably OnCore.
• 5–7 Years of related clinical research coordination experience.

Orange County, CA $93,700.00 – $

Conditions of Employment:
Background Check and Live Scan;
Employment Misconduct;
Legal Right…