Updated: Apr 19, 2021 Location: UC Irvine Campus Job Type: Department: UCI Ctr for Clinical Research
Job Opening ID: 17150
Reports To: Director of Clinical Research Operations
Working Title: Regulatory Coordinator
Department: UCI Ctr for Clinical Research
Bargaining Unit: RX
Payroll Job Code: 009335
Job Location: UCI Campus- Irvine
Percent of Time: 100%
Work Schedule: 8-5, M-F
Employee Class: Career
Under the supervision of the Regulatory Supervisor of the Center for Clinical Research (CCR), the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the UCI CCR by providing comprehensive, regulatory management of clinical trial protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures. Responsibilities related to regulatory coordination activities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, but not limited to, CCR Administration Teams, Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Epidemiology Infectious Prevention (EIP). The RAC is responsible for effectively shepherding protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned. In addition, the RAC serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed. 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. The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies.
3 to 5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience.
Experience with submitting to various institutional research committees, i.e., Institutional Review Board, Feasibility Committee, Data Safety Monitoring Board, Institutional Biosafety, Radiation Safety Committee, and Epidemiology Infectious Prevention.
Ability to interact with the public, faculty, and staff.
Ability to establish and maintain files and records.
Access to transportation to off-site research locations.
Willingness to work as a supportive, cooperative member of an interdisciplinary team.
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.
Ability to multitask and meet deadlines, despite interruptions.
Ability to independently exercise discretion and sound judgment.
Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships.
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 concerns.
Ability to work within a deadline-driven structure.
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.
Strong attention to detail. Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
SoCRA or ACRP Certified Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored). Experience with clinical trial management systems, preferably OnCore.
Knowledge Kuali Financial System and Kuali Coeus.
Knowledge of University IRB policies and procedures as they apply to the submission and conduct of clinical research.
Familiarity with University contract and grant procedures in the conduct of clinical trials.
Knowledge of basic accounting and familiarity with UCI fund accounting and disbursement procedures.
Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.
Since 1965, the University of California, Irvine has combined the strengths of a major research university with the bounty of an incomparable Southern California location. UCI's unyielding commitment to rigorous academics, cutting-edge research, and leadership and character development makes the campus a driving force for innovation and discovery that serves our local, national and global communities.