Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Senior Regulatory Affairs Coordinator (SRAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing study start-up regulatory management for high-priority cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures. Primarily, the incumbent will manage all study-start up activities for high priority trials and will also be responsible for managing the multi-site investigator-initiated research portfolio. 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 for high-priority 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) across all disease sites. The SRAC is responsible for effectively shepherding protocols through the regulatory committee process in an expedited manner to ensure expedient activation of trial and for all regulatory aspects of the protocols assigned. Additionally, the incumbent will be responsible for managing all components of multi-site investigator-initiated protocols. S/he will be responsible for developing multi-site processes, checklists and templates for both standardization and ensure compliance with federal, state, and university regulations for the management and coordination for all investigator-initiated trials with sub-sites in collaboration with the Regulatory Program Manager. In addition, the SRAC serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to 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).
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.
Salary: Hourly $31.32 - $39.37 Total Hours: 8-5, M-F Career Position. 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. Please attach your resume.
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.