REGULATORY AFFAIRS MANAGER

University of California, Irvine; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

The University of California, Irvine seeks a Regulatory Affairs Manager to oversee clinical research regulatory matters. The role involves managing staff, ensuring compliance with guidelines, and providing analytical support for strategic initiatives. The ideal candidate will have a strong background in regulatory oversight and excellent communication skills.

Benefits

Medical Insurance

Sick and Vacation Time

Retirement Savings Plans

Qualifications

• 5 - 7 years of experience in regulatory oversight.
• Ability to work independently and as part of a team.
• Experience with clinical research and data collection methods.

Responsibilities

• Directs and supervises regulatory affairs for clinical research.
• Ensures protocols meet institutional, state, and federal guidelines.
• Manages staff and oversees regulatory operations.

Skills

Communication

Problem Solving

Organizational Skills

Interpersonal Skills

Technical Writing

Education

Bachelor's degree in related area

Tools

Microsoft Office

Job description

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nations 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. Its located in one of the worlds safest and most economically vibrant communities and is Orange Countys 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 is driven to improve the 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.

Built as an excellent clinical research program designed to serve our patients, community, investigators and partners with a high level of efficiency, integrity and quality. With hundreds of clinicians and researchers dedicated to innovating, accelerating, growing and inspiring new ways to address and treat disease. Their expertise gives us an edge in treatments and trials related to a full spectrum of conditions.

Our devoted team of nationally regarded physicians and nurses, researchers and clinicians, educators and students are all united by a single calling to improve the lives of the people in our community and beyond. We are unique in our ability to provide the most compassionate healthcare and research because we are driven by our passion for innovation, grounded in the best medical and scientific knowledge available.

Responsibilities :

Under the general direction of the Director of Clinical Research, Administration, and Finance of the Center for Clinical Research (CCR), and the Assistant Director of Clinical Research Operations, the Regulatory Affairs Manager (RAM) is responsible for all clinical research regulatory matters in fulfilling the mission of CCR under the University Of California Irvine School Of Medicine and the overall UC Irvine Health enterprise. Provides high-level analytical support for strategic initiatives for the regulatory operations and implementations of CCRs clinical trial portfolio.

The RAM independently directs and supervises the day-to-day management of critical regulatory requirements for clinical research within CCR and has primary responsibility for overseeing regulatory affairs coordinators who are responsible for submitting protocols to clinical research committees [e.g. Institutional Review Board (IRB)]. The RAM is directly responsible for ensuring protocols are appropriately shepherded through the regulatory process in order to meet the goal of protocol activation for research participant accrual in accordance with institutional, state and federal guidelines.

The RAM 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 RAM 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.

Qualifications : Required :

• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters.
• Demonstrated experience in supervising staff in research environment.
• 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) and financial software.
• Experience working in a multidisciplinary matrixed work environment.
• 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 - 7 years of experience with BA / BS or equivalent experience years in regulatory oversight in an academic and / or research environment. Advanced degree and SoCRA / ACRP certification preferred.

Preferred :

• Experience working in Forte's OnCore Clinical Trials Management System (CTMS).
• Advanced degree preferred.

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
• 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 Californias Affirmative Action Policy please visit : https : / / policy.ucop.edu / doc / 4010393 / PPSM-20 .

For the University of Californias 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 [phone] or [emailprotected] .

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Regulatory Manager • Irvine, CA, United States