Under the supervision of the Director of Clinical Research Operations of 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.
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 $26.64 - $33.49 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.