Assistant Regulatory Affairs Coordinator - Hybrid

University of California, Irvine•Orange, CA

2d•Hybrid

About The Position

Under the supervision of the Regulatory Program Manager of the Regulatory Review Unit, the Assistant Regulatory Affairs Coordinator (ARAC) supports the clinical research efforts of the 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 ARAC 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).

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
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
1-3 Years of related work coordination work experience with 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.

Nice To Haves

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.

Responsibilities

Managing and preparing 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).
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.
Serving as the liaison to sponsors, governing agencies and facilitating transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed.
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.
Accurately maintaining regulatory information in the clinical trial management system (OnCore).
Adhering to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).