Updated: Sep 22, 2020 Location: UC Irvine Campus Job Type: Department: CANCER CENTER
Job Opening ID: 11282
Reports To: CLIN RSCH SUPV 1
Working Title: Regulatory Affairs Coordinator
Department: CANCER CENTER
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 Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures. The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients. 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, Disease-Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring Board (DSMB), 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, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, 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 and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).
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, Protocol Review Monitoring 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. 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).
Experience with cancer-related research. 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.
Special Conditions Required:
May require study management coordination outside of normal business hours. May require travel to satellite sites.
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.