UC Irvine · 1 month ago
Sr. Clinical Research Coordinator - Hybrid
Orange County, CA
Full-time
Hybrid
Senior Level
5+ years expUC Irvine is a prestigious public university known for its academic achievement and research innovation. The Senior Clinical Research Coordinator will support the clinical research efforts of the Department of Orthopaedic Surgery by coordinating various aspects of clinical trials, ensuring regulatory compliance, and maintaining communication with research networks.
Higher Education
Responsibilities
Support 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 procedure (SOPs), and University policies and procedures
Support and coordinate all aspects of the clinical research for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping
Prepare study IRB applications and maintain regulatory compliance
Attend clinic to assist the Principal Investigator (PI) and other research personnel with recruitment, screening, consenting, administering questionnaires, answer patient research questions, schedule 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
Maintain communication with all elements of multi-level research networks, including attending meetings, interacting with sponsoring agencies including National Institute of Health, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors
Provide training and guidance to other clinical research personnel and trainees, demonstrating best practices, and provides ongoing analysis of internal processes and provides recommendations for new policies and procedures to improve overall operational efficiency and customer service
Lead and manage 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
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)
Qualification
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, compiles data from various sources, analyze data, and prepare reports
Ability to work both independently and as part of team
Ability to take initiative and demonstrate strong commitment to duties
Ability to perform ongoing needs analysis and recommend solutions to resolve concern
Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change
High level of integrity and honesty in maintaining confidentiality
Foster and promote a positive attitude and professional appearance
Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint)
Knowledge with various types of human subject clinical trials i.e., National Group, industrial, and investigator authored
Bachelor's degree in related area and/or equivalent experience/training
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
2 or more years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
Demonstrated track record of human subject's research (Phase I, II, III drug trials, and device trials) coordination, informed consent procedures and documents, and IRB submission
Experience working in a medical/clinical setting and familiarity with medical terminology
Preferred
Current nationally recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.)
Experience with clinical trial management systems, preferably OnCore
5 to 7 Years of related clinical research coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
Benefits
Medical insurance
Sick and vacation time
Retirement savings plans
Access to a number of discounts and perks
Company
UC Irvine
UC Irvine
10001+ employees
H1B Sponsorship
UC Irvine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (113)
2024 (86)
2023 (99)
2022 (76)
2021 (81)
2020 (79)
Funding
Current Stage
Late StageLeadership Team
Anand Gala
CEO Roundtable Member
Bob Romney
Chancellor's CEO Roundtable
Recent News
Business News: Pasadena Star-News
2025-12-29
2025-08-08
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