Regulatory Affairs Coordinator

University of California, Irvine•Orange, CA

3d•Hybrid

About The Position

The UCI Center for Clinical Research (CCR) is seeking a Regulatory Affairs Coordinator to manage the regulatory aspects of clinical trials. This role involves managing complex, multi-phase clinical research protocols from initiation through completion, ensuring compliance with all regulatory requirements for studies involving human subjects. The incumbent will lead study-related meetings, manage the investigator site file, and ensure all necessary regulatory documentation is collected in line with established study protocols. Projects may include industry-sponsored, federally-funded, and/or investigator-initiated studies. Additionally, the incumbent will 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. The role also includes ensuring all submissions and reportable events are reported to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and/or sponsor monitors within the applicable time frame. The incumbent will 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. The incumbent is responsible for maintaining 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. This individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies. The main CCR offices and clinics are located at the UCI Medical Center in Orange and the UCI campus in Irvine, as well as various clinics at community sites throughout Orange County. The incumbent will be required to work at both main locations in Orange and Irvine, and sometimes community sites depending on responsibilities and scheduling demands.

Requirements

Experience submitting IRB applications (Initial, Amendments, Continuing Reviews, and Reportable Events)
Ability to establish and maintain effective working relationships across the Health System.
Ability to maintain a work pace appropriate to the workload.
Must demonstrate customer service skills appropriate to the job.
Excellent written and verbal communication skills in English
Must possess the skill, knowledge and ability essential to the successful performance of assigned duties
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
Must be able to provide proof of work authorization

Nice To Haves

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
Demonstrated in-depth understanding of regulatory affairs regulations in clinical research (Phase I, II, III drug trials, and device trials), IRB submissions, and all regulatory aspects of the study.
Working knowledge of various types of human subject clinical trials (i.e. National Group, Industrial, and Investigator-authored).

Responsibilities

Manage the regulatory aspect of clinical trials in the UCI Center for Clinical Research (CCR).
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.
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.
Ensure all submissions and reportable events are reported to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and/or sponsor monitors within the applicable time frame.
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.
Interact with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
Accurately maintain clinical trial information in the clinical trial management system (OnCore).
Adhere to institutional policies.