Assistant Director, Regulatory Affairs - Hybrid

University of California, Irvine•Orange, CA

22h•Hybrid

About The Position

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 hundreds of members engaged in research and offers multidisciplinary cancer care to its patients. The Stern Center for Cancer Clinical Trials & Research (Stern Center) is the centralized office for cancer clinical research operations at UCI and is the best-practice leader in clinical research operations at UC Irvine. There are five distinct and collaborative units: Quality Assurance, Protocol Review and Monitoring, Regulatory Affairs, Clinical Trials, and Clinical Research Business Operations. These units provide administrative expertise, comprehensive regulatory management, clinical research coordination, data management, quality control, and business operations support to all CFCCC members. Your Role on the Team The Assistant Director for Regulatory Affairs (AD-RA) independently directs and supervises the Regulatory Affairs Unit, one of five units within the Stern Center for Cancer Clinical Trials & Research. S/he is responsible for the day-to-day management of critical regulatory requirements for clinical research within the CFCCC and has primary responsibility for overseeing both pre-award regulatory affairs coordinators and maintenance regulatory affairs coordinators, a 14 team unit responsible for submitting protocols to clinical research regulatory committees (e.g., Protocol Review & Monitoring Committee (PRMC), Radiation Safety Committee (RSC), Institutional Review Board (IRB), etc.). The AD-RA is directly responsible for ensuring protocols are appropriately shepherded through the regulatory process to meet the goal of protocol activation for research participant accrual in accordance with institutional and federal (National Cancer Institute) requirements (e.g. 90 day activation timeframe for industry trials, etc.). The AD-RA reports to the Senior Director for Clinical Research Operations for all clinical research regulatory matters fulfilling the mission of the Chao Family Comprehensive Cancer Center, the University of California Irvine School of Medicine and the overall UC Irvine Health enterprise. The AD-RA is responsible for directing, administering, and achieving operational goals and objectives for the implementation and oversight of new operational strategies and unit goals within the regulatory arena. The RPM is directly responsible for management of staff. The supervisory role is composed of staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and all other HR-related functions. The AD-RA Recommends and implements policies and procedures based on federal and state agency regulations for relevant compliance area. Provides leadership to solve issues related to compliance committees (e.g. RSC, IRB, IBC, PRMC, etc.). S/he manages all issues related to relevant compliance areas. Serves as a liaison between the organization and federal regulators (e.g. FDA, OHRP, etc.), in addition to representing the organization at regional conferences and meetings. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Provides guidance to subordinates to achieve goals in accordance with established policies. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

Requirements

Ability to formulate policy recommendations.
Ability to apply a complex array of issues, mental flexibility, and creativity related to compliance issues.
Skill in establishing relationships with relevant regulatory agencies.
Managerial experience and proven success in managing compliance review boards or committees.
Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters.
Advanced knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations
Effective oral and written communication skills with technical writing skills sufficient to compose a variety of scientific documents, reports, budgets and justifications which are clear, concise, logical and display syntax and grammar.
Working knowledge of clinical protocol design, content and categories for inclusion in a final document.
Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy.
Ability to establish and maintain cooperative working relationships with colleagues, faculty and staff.
Excellent interpersonal, organizational and time management skills
Ability to work both independently and as part of team
Ability to take initiative and demonstrate strong commitment to duties. Ability to act independently with demonstrated problem-solving skills, multi-task and to follow through on assignments with minimal direction.
Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent.
Ability to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentation.
Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative.
Skill in performing a variety of duties, often changing from one to another with frequent interruptions.
Skill in composing letters, preparing documents, and facilitating the production of materials.
Experience with clinical research and data collection methods.
Ability to work within a deadline-driven structure
Demonstrated experience in maintaining flexibility and adaptability while leading and implementing institutional change
Foster and promote a positive attitude and professional appearance
Expertise with Microsoft Office (Word, Excel, Outlook, Powerpoint).
Bachelor's degree in related area and / or equivalent experience / training
Minimum of 7-9 years of experience with BA/BS or equivalent experience years in regulatory oversight in an academic and/or research environment.
Experience overseeing oncology clinical research

Nice To Haves

Familiarity with Cancer Center Support Grant guidelines
Experience working in Forte's OnCore Clinical Trials Management System (CTMS)
Experience working in a multidisciplinary matrixed work environment

Responsibilities

Directs and supervises the Regulatory Affairs Unit
Responsible for the day-to-day management of critical regulatory requirements for clinical research within the CFCCC
Overseeing both pre-award regulatory affairs coordinators and maintenance regulatory affairs coordinators
Ensuring protocols are appropriately shepherded through the regulatory process to meet the goal of protocol activation for research participant accrual in accordance with institutional and federal (National Cancer Institute) requirements
Directing, administering, and achieving operational goals and objectives for the implementation and oversight of new operational strategies and unit goals within the regulatory arena
Management of staff including staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and all other HR-related functions
Recommends and implements policies and procedures based on federal and state agency regulations for relevant compliance area
Provides leadership to solve issues related to compliance committees
Manages all issues related to relevant compliance areas
Serves as a liaison between the organization and federal regulators
Representing the organization at regional conferences and meetings
Provides guidance to subordinates to achieve goals in accordance with established policies