Sr. Regulatory Affairs Coordinator- HYBRID - University of California, Irvine

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu.

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.

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.

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).

Required:

• 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
• Bachelor's degree in related area and / or equivalent experience / training.
• 5 to 7 years of related work coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
• 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.

Preferred:

• 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:

• May require study management coordination outside of normal business hours.
• May require travel to satellite sites.

Total Compensation

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.

Conditions of Employment:

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

• Background Check and Live Scan
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php

Closing Statement:

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California’s Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20.

For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination.

We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or eec@uci.edu.