Regulatory Affairs Coordinator

About the role

The UCI Center for Clinical Research (CCR) is seeking a Regulatory Affairs Coordinator to join our dynamic team. The ideal candidate will independently or under supervision manage and conduct complex, multi-phase clinical research protocols from initiation through completion, ensuring compliance with all regulatory requirements.

Responsibilities

• Manage and conduct complex, multi-phase clinical research protocols from initiation through completion, ensuring compliance with all regulatory requirements for studies involving human subjects.
• Lead study-related meetings, manage the investigator site file, and ensure all necessary regulatory documentation is collected in line with established study protocols.
• Develop and implement processes for reviewing and overseeing clinical trials, ensuring adherence to study protocols, proper documentation, and accurate data collection in accordance with Good Clinical Practice (GCP), internal standard operating procedures (SOPs), and University policies.
• Accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies.
• Work with the clinical research team to manage and collect accurate information and assist Principal Investigators and study coordinators with all regulatory aspects of non-cancer-related trials.
• Maintain communication with all elements of a multi-level research network, interacting with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

Requirements

• Experience submitting IRB applications (Initial, Amendments, Continuing Reviews, and Reportable Events).
• Establish and maintain effective working relationships across the Health System.
• Excellent written and verbal communication skills in English.
• Proven ability to research, properly evaluate information, and prepare clear, concise and well-organized reports, summaries, and correspondence; ability to think critically, compile data from various sources, analyze and synthesize data/information and present it to others in a clear and concise way.
• Proven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team.
• Proven ability to analyze and solve problems, implement solutions, and resolve concerns that arise unexpectedly.
• Proven ability to independently exercise discretion and sound judgment.
• High level of integrity and honesty in maintaining confidentiality.
• Proven ability to maintain flexibility and adaptability.
• Proven ability to establish and maintain files and records.
• Experienced with the software including Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams, and etc.), Zoom, and etc.
• Proven ability to establish and maintain cooperative and collegial working relationships; demonstrated skill in interacting with the public, faculty and staff of various social, cultural, economic and educational backgrounds.
• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• A minimum of 3-5 years of related work experience as a regulatory affairs coordinator (RAC) or an assistant RAC with a Bachelor’s degree or equivalent experience.

Preferred Knowledge

• Knowledge of clinical trial federal, state and local regulations.
• Working knowledge of various types of human subject clinical trials (i.e. National Group, Industrial, and Investigator-authored).
• Research Certification (e.g. ACRP, SoCRA, CCRP) preferred.
• Current CITI training certification.