Assistant Regulatory Affairs Coordinator - Hybrid

About the role

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 Assistant Regulatory Affairs Coordinator (ARAC) supports the clinical research efforts of the Cancer Center by providing comprehensive, regulatory management of cancer-related protocols.

Responsibilities

• Manage and prepare submissions of 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).
• Shepherd protocols through the regulatory committee process in a timely manner to ensure activation of trial and handle all regulatory aspects of the protocols assigned.
• Serve as the liaison to sponsors, governing agencies, and facilitate transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed.
• Maintain 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.
• 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).

Requirements

• 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.
• Able to multitask and meet deadlines, despite interruptions.
• Able 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.
• 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 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.