Regulatory Affairs & Quality Assurance Manager

Overview:

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 UCI Center for Clinical Research (CCR) is driven to improve health and wellness of people in Orange County and the world by providing life\-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic.

Responsibilities:

Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Manager of Regulatory Affairs and Quality Assurance is responsible for all clinical research regulatory and quality assurance operational matters in fulfilling the mission of CCR under the University of California, Irvine \- School of Medicine and the overall UC Irvine Health enterprise. Serving as an administrative and operational leader, the Manager directly oversees the Regulatory Affairs Supervisor and the Quality Assurance and Improvement Supervisor and their respective teams, and is accountable for unit\-level operational effectiveness across regulatory compliance, quality assurance, training, and process improvement functions. The Manager leads workforce planning, operational strategy development, and continuous quality improvement initiatives that support CCR's mission, regulatory compliance standards, and financial sustainability.

The Manager independently directs and supervises the day\-to\-day management of critical regulatory requirements and quality assurance activities for clinical research within CCR. The Manager has primary responsibility for overseeing the Regulatory Affairs Supervisor, who manages staff responsible for submitting protocols to clinical research committees (e.g., Institutional Review Board \[IRB]), and the Quality Assurance and Improvement Supervisor, who is responsible for monitoring, auditing, and continuous improvement of clinical research operations.

The Manager 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 and quality assurance arenas. This includes staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management, and all other HR\-related functions across both units.

The Manager builds and maintains a culture of excellence, safety, and compliance with the goal of achieving an audit\-ready operation at all times. This position is responsible for establishing and maintaining strong relationships with investigators, clinicians, coordinators, administrators, patients, sponsors, site monitors, and institutional compliance bodies. Provides high\-level analytical support for strategic initiatives for the regulatory and quality assurance operations and implementations of CCR's clinical trial portfolio.

Work is primarily on\-site across clinical and administrative locations. Remote work will only be approved with authorization from the Assistant Director.

Qualifications:

Required:

• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters
• Demonstrated experience in supervising staff in a research environment, including managing supervisors and multi\-level teams
• Demonstrated strong management, leadership, and supervisory skills across a diverse population
• Deep content expertise in clinical research regulatory affairs and quality assurance operations
• Proven track record of excellent leadership required for fostering effective collaboration between executive leadership and research operations leadership
• Demonstrated ability to lead strategic initiatives across regulatory and quality functions
• Effective oral and written communication skills with technical writing skills sufficient to compose a variety of scientific documents, reports, and justifications which are clear, concise, logical, and grammatically correct
• 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 a 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 task 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)
• Experience working in OnCore Clinical Trials Management System (CTMS) or equivalent
• Experience working in a multidisciplinary matrixed work environment
• Thorough understanding of FDA regulations, GCP, ICH guidelines, and HIPAA requirements pertinent to research
• Knowledge and experience with quality assurance methods, CAPA development, and audit management
• Experience working with IRB, FDA, and other regulatory bodies
• Bachelor's degree in related area and / or equivalent experience / training
• Clinical Trial Professional certification from a professional society within one year in position.
• Minimum 5\-7 years of related work experience with BA/BS or equivalent experience in regulatory oversight and/or quality assurance in an academic and/or clinical research environment

Preferred:

• Knowledge of research billing and budget management
• Familiarity with FDA inspection process
• Advanced degree preferred.

Special Conditions:

• Some after business hours and occasional weekends may be required
• Flexible for travel between Irvine Campus and UCI Medical Center Orange Campus

Total Rewards

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

Employment Misconduct\

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

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.*

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 is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti\-Discrimination Policy.

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.