Research Compliance Manager 1

The Assistant Director, Regulatory Unit, reports directly to the Executive Director of the Office of Clinical Research (OCR), and is responsible for the management and oversight of clinical research regulatory operations for the OCR. The incumbent is accountable for all UC Davis Comprehensive Cancer Center (UCDCCC) clinical research regulatory matters and serves as an external technical resource to UCDH and UC/UCOP as needed. #CA-SB

Apply By Date 11/7/2025 by 11:59pm

Minimum Qualifications - For full consideration, applicants are encouraged to upload license and/or certification if required of the position

• Bachelor's degree (Masters preferred) in Business or Healthcare field.
• Seven (7) to ten (10) years of experience in regulatory oversight in an academic and/or research environment.
• Three (3) to five (5) years of progressive leadership experience.
• Advanced experience in a research environment required.
• Strong leadership, team building, and problem-solving skills as well as demonstrated ability to work collaboratively with multiple disciplines (i.e., physicians, administrative, supervisory, and allied health staff).
• Advanced knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations.
• Advanced knowledge of clinical protocol design, content and categories.
• Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters.
• Advanced experience with clinical research and data collection methods.
• 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 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.
• Advanced skill in writing, preparing documents, and facilitating the production of materials.
• Demonstrated experience in maintaining flexibility and adaptability while leading and implementing institutional change.
• Foster and promote a positive attitude and professional appearance.

Preferred Qualifications

• Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification.
• Masters in Business or Healthcare.
• Experience overseeing oncology clinical research
• Familiarity with Cancer Center Support Grant guidelines
• Experience working with OnCore Clinical Trials Management System and Florence e-Regulatory binder system.

Key Responsibilities

• 40% - Organizational Responsibilties
• 40% - Operational Responsibilities
• 10% - Personnel
• 10% - Compliance Responsibilities

Department Overview

The UC Davis Comprehensive Cancer Center (UCDCCC) is a campus-wide multidisciplinary matrix organization whose mission is to reduce the burden of cancer among the diverse populations in our community and beyond through bidirectional engagement and transdisciplinary collaborations that enhance our understanding of cancer, inform new ways to prevent and treat cancer, and prepares a committed and inclusive workforce. The Office of Clinical Research (OCR) is the centralized office for clinical research operations within UCDCCC. The OCR services support the entire lifecycle of cancer-related clinical research protocols. These include support for development and implementation of clinical trials, quality control of clinical research operations, and training and education services.

Department Specific Job Scope

The Assistant Director, Regulatory Unit, independently directs critical regulatory requirements for clinical research within the UCDCCC and oversees the Regulatory Supervisor(s) and Regulatory Research Coordinators (RRCs) who are responsible for submitting protocols to clinical research committees (e.g., Institutional Review Board [IRB], Scientific Review Committee [SRC], etc.). The Assistant Director, Regulatory Unit, is directly responsible for ensuring protocols are appropriately managed through the regulatory process in order to meet the goal of protocol activation for research participant accrual in accordance with institutional and federal requirements.

The Assistant Director, Regulatory Unit, provides strategic oversight for the UCDCCC's multi-site Investigator-Initiated Trial (IIT) program, including supervision of the multi-site IIT Program Manager and coordination of regulatory activities across multiple external participating sites. This includes ensuring consistent application of regulatory standards, efficient communication pathways, and adherence to sponsor-investigator obligations under FDA and NIH regulations.

The position 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 Assistant Director, Regulatory Unit, is directly responsible for management of staff to include developing and implementing a performance management program, leading staff training and development, organizational operations, and all other HR-related functions.

POSITION INFORMATION

• Salary or Pay Range: $8,533.33 - $18,666.67
• Salary Frequency: Monthly
• Annual Salary: $102,400 - $202,400
• Salary Grade: Grade 25
• UC Job Title: RSCH CMPLNC MGR 1
• UC Job Code: 000375
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100
• Shift (Work Schedule): 8am-5pm
• Location: Facilities Support Srvcs Bldg (HSP068)
• Union Representation: 99 - Non-Represented (PPSM)
• Benefits Eligible: Yes
• This position is hybrid (mix of on-site and remote work)

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.

If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html

• High quality and low-cost medical plans to choose from to fit your family's needs
• UC pays for Dental and Vision insurance premiums for you and your family
• Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave
• Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Access to free professional development courses and learning opportunities for personal and professional growth
• WorkLife and Wellness programs and resources
• On-site Employee Assistance Program including access to free mental health services
• Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
• Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
• Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here

Physical Demands

• Standing - Occasional Up to 3 Hours
• Walking - Occasional Up to 3 Hours
• Sitting - Frequent 3 to 6 Hours
• Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
• Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours
• Bending/Stooping - Occasional Up to 3 Hours
• Squatting/Kneeling - Occasional Up to 3 Hours
• Twisting - Occasional Up to 3 Hours
• Reaching overhead - Occasional Up to 3 Hours
• Keyboard use/repetitive motion - Frequent 3 to 6 Hours

Mental Demands

• Sustained attention and concentration - Frequent 3 to 6 Hours
• Complex problem solving/reasoning - Occasional Up to 3 Hours
• Ability to organize & prioritize - Frequent 3 to 6 Hours
• Communication skills - Frequent 3 to 6 Hours
• Numerical skills - Occasional Up to 3 Hours
• Constant Interaction - Frequent 3 to 6 Hours
• Customer/Patient Contact - Frequent 3 to 6 Hours
• Multiple Concurrent Tasks - Frequent 3 to 6 Hours

Work Environment

UC Davis is a smoke and tobacco free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e-cigarettes) will be strictly prohibited on any UC Davis owned or leased property, indoors and outdoors, including parking lots and residential space.
Special Requirements - Please contact your recruiter with questions regarding which activities apply by position

• This is a critical position, as defined by UC Policy and local procedures, and as such, employment is contingent upon clearing a criminal background check(s) and may include drug screening, medical evaluation clearance and functional capacity assessment
• This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements
• 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.

A Culture of Opportunity and Belonging

At UC Davis, we're committed to solving life's most urgent challenges and building a healthier, more resilient world. We believe in growing through every challenge, continually striving to improve, and welcoming new perspectives that strengthen our community. We recognize that a vibrant and innovative organization values both individual strengths and shared purpose. The best ideas often emerge when people with different experiences come together.

As you consider joining UC Davis, we invite you to explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education. We believe you belong here. The University of California, Davis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

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

Because we want you to feel seen and valued, our recruitment process at UC Davis supports openness and authenticity. Research shows that some individuals hesitate to apply unless they meet every qualification. You may be an excellent fit for this role-or the next one. We encourage you to apply even if your experience doesn't match every listed requirement. #YouBelongHere

To learn more about our background check program, please visit: https://hr.ucdavis.edu/departments/recruitment/ucd/selection/background-checks