Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

Req ID: 147613

Location: Orange, California

Division: School of Medicine

Department: UCI Ctr for Clinical Research

Position Type: Full Time

Salary Range Minimum: USD $35.77/Hr.

Salary Range Maximum: USD $58.96/Hr.

Who We Are

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.

To learn more about UC Irvine, visit www.uci.edu.

The UCI Center for Clinical Research (CCR) is driven to improve health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic.

Your Role on the Team

Independently or under the supervision of the Regulatory Affairs Manager and Assistant Director of Clinical Research Operations, the incumbent is in charge of the regulatory aspect of clinical trials in the UCI Center for Clinical Research (CCR). The role involves managing and conducting 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.

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 also 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. In addition, 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.

What It Takes to be Successful

Required:

• 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

Preferred:

• 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).

Special Conditions:

• May require study management outside normal business hours
• May require travel to off-site research locations