Supervisor, Study Startup and Regulatory

University of California, Irvine•Irvine, CA

22h•Onsite

About The Position

Under the general direction of the Assistant Director, Research Operations of the Sue & Bill Gross Stem Cell Research Center for Clinical Research (SCRC), the Supervisor, Study Startup and Regulatory is responsible for all startup and regulatory matters in fulfilling the mission of Alpha Stem Cell Clinic and the overall UC Irvine Health enterprise. Provides high-level analytical support for strategic initiatives for the study startup and regulatory operations and implementations of ASCC’s clinical trial portfolio. The Supervisor, Study Startup and Regulatory independently directs and supervises the day-to-day management of critical startup and regulatory requirements for clinical research within ASCC and has primary responsibility for overseeing startup and regulatory affairs coordinators who are responsible for creating, negotiating, and monitoring budgets for clinical trials and grants, and regulatory coordination activities for UCI Alpha Clinic. The Supervisor, Study Startup and Regulatory is directly responsible for ensuring protocols are appropriately shepherded through the startup and regulatory process in order to meet the goal of protocol activation for research participant accrual in accordance with institutional, state and federal guidelines. The Supervisor, Study Startup and Regulatory 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 startup and regulatory arena. The Supervisor, Study Startup and Regulatory, is directly responsible for management of staff. The supervisory role is composed of work assignment, implementing the performance management program, leading staff learning and development, leave management and schedules, and other HR-related functions. The Supervisor, Study Startup and Regulatory recommends and implements policies and procedures based on federal and state agency regulations for relevant compliance area. They provide leadership to solve issues related to compliance committees (e.g. RSC, IRB, IBC, PRMC, etc.). They manage all issues related to relevant compliance areas. Serve as a liaison between the organization and federal regulators (e.g. FDA, OHRP, etc.). They receive 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

Thorough understanding of research administration guidelines of Federal and non-Federal sponsors supporting research and educational activities, preferably in a university environment.
Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment.
Adaptable to quickly changing priorities.
Demonstrated skills in employee supervision and HR administration.
Demonstrated experience in training others, particularly in the field of research.
Critical thinking skills to evaluate issues and identify a potential solution.
Clear and concise communicator; good verbal and written communication skills.
Good interpersonal skills, including problem-solving, teamwork development, leadership, and mentorship.
Interpersonal skills to effectively motivate others.
Works well with others to achieve common goals.
Ability to cultivate relationships with multiple stakeholders at various levels of administration.
Thorough knowledge of applicable compliance requirements related to use of human or animal subjects in research, financial conflict of interest, biosafety, etc.
Ability to manage significant volume of transactions.
Ability to perform complex financial analysis and customized reporting.
Demonstrated competence in the use of spreadsheet and database software in financial analysis, fiscal management and financial reports.
Ability to maintain independent judgment; strong organization and communication skills; and a customer service focus across broad and diverse subject areas.
Maintains current knowledge of compliance regulations in all areas of research administration.
Demonstrated knowledge of generally accepted accounting, fiscal and reporting principles.
Bachelor's degree in related area and / or equivalent experience / training.
Clinical Trial Professional certification from a professional society within one year in position.
5-10 years of experience.
Must be able to provide proof of work authorization.

Nice To Haves

Demonstrated knowledge of effective grant funding processes, procedures and techniques.
Strong writing skills in a variety of styles to draft persuasive text for a variety of audiences while ensuring adherence to funding sponsor’s guidelines.
Advanced degree preferred.

Responsibilities

Directs and supervises the day-to-day management of critical startup and regulatory requirements for clinical research within ASCC.
Oversees startup and regulatory affairs coordinators responsible for creating, negotiating, and monitoring budgets for clinical trials and grants, and regulatory coordination activities for UCI Alpha Clinic.
Ensures protocols are appropriately shepherded through the startup and regulatory process to meet the goal of protocol activation for research participant accrual in accordance with institutional, state and federal guidelines.
Directs, administers, and achieves operational goals and objectives for the implementation and oversight of new operational strategies and unit goals within the startup and regulatory arena.
Manages staff, including work assignment, implementing performance management, leading staff learning and development, leave management, and other HR-related functions.
Recommends and implements policies and procedures based on federal and state agency regulations.
Provides leadership to solve issues related to compliance committees (e.g., RSC, IRB, IBC, PRMC).
Manages all issues related to relevant compliance areas.
Serves as a liaison between the organization and federal regulators (e.g., FDA, OHRP).
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.