The Regulatory Research Coordinator (RRC) supports the clinical research efforts of the UC Davis Comprehensive Cancer Center (UCDCCC) by providing comprehensive regulatory management of complex cancer-related protocols in accordance with human subject federal regulations, Good Clinical Practice, internal standard operating procedures (SOPs), and University policies and procedures.

Apply By Date 6/15/2026 by 11:59pm

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

• High School graduation or GED equivalent and/or equivalent experience/training and/or demonstrated skills to successfully perform the assigned duties and responsibilities.
• At least two (2) years of directly related clinical research or regulatory coordination experience.
• Knowledge of clinical research regulations and guidelines, including Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations, Office for Human Research Protections (OHRP) requirements, and HIPAA/privacy requirements as applicable to human subjects research.
• Knowledge of clinical trial regulatory processes, including preparation and submission of initial reviews, modifications, continuing reviews, reportable events, and study closures for IRB and other oversight committees.
• Demonstrated ability to independently manage multiple competing priorities and regulatory deadlines within a high-volume, complex clinical research environment.
• Analytical and critical thinking skills to interpret regulations, policies, protocol requirements, and operational issues; identify compliance risks; and formulate logical, well-reasoned solutions.
• Strong organizational skills and attention to detail to accurately maintain large volumes of regulatory records and documentation while ensuring compliance and timely completion of assignments.
• Written communication skills sufficient to prepare clear, accurate, and professional regulatory submissions, correspondence, reports, and study documentation using correct grammar, spelling, and punctuation.
• Oral communication and interpersonal skills to effectively collaborate with investigators, sponsors, IRBs, regulatory agencies, research staff, clinical personnel, and other internal and external stakeholders.
• Knowledge of medical terminology, anatomy, disease processes, and interpretation of medical records, laboratory reports, physician documentation, and diagnostic results as applied to oncology clinical research.
• Experience with tracking systems, recordkeeping, and maintaining regulatory documentation in accordance with GCP and institutional requirements.
• Working knowledge of Microsoft Office Suite and ability to learn and effectively utilize clinical research systems and databases including electronic regulatory and clinical trial management systems.
• Ability to exercise sound judgment, demonstrate initiative, and work independently while also contributing effectively within a collaborative team environment.
• Ability to adapt to changing priorities, regulatory requirements, and operational needs in a fast-paced clinical research environment.

Preferred Qualifications

• Certification in clinical research (e.g., ACRP or SOCRA certification) or eligibility to obtain certification.
• Bachelor's degree, preferably in the sciences or health related field.
• Experience independently managing regulatory activities for complex oncology clinical trials, including early phase, investigator-initiated, multi-site, and/or federally funded studies.
• Advanced knowledge of oncology clinical research regulations, FDA guidance documents, NCI requirements, and institutional policies related to human subjects research.
• Experience preparing and maintaining Investigator Site Files/eRegulatory systems in a manner consistent with audit and inspection readiness standards.
• Experience supporting regulatory activities for audits, inspections, or monitoring visits conducted by sponsors, CROs, FDA, NCI, or other regulatory authorities.
• Experience utilizing clinical trial management systems and electronic regulatory platforms such as OnCore, Florence eBinders, Velos, or similar systems.
• Ability to proactively identify process improvement opportunities and contribute to operational efficiencies within a clinical research program.
• Experience interpreting and applying complex protocol requirements and regulatory guidance to non-routine or ambiguous study scenarios.

Key Responsibilities

• 80% - Regulatory Management
• 10% - Quality Assurance
• 5% - Meeting Participation and Continuing Education
• 5% - Other Duties

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 Regulatory Research Coordinator (RRC) independently manages regulatory activities for a complex portfolio of oncology clinical trials, ensuring compliance with federal, state, sponsor, and institutional requirements governing human subjects research. The incumbent is responsible for preparing, coordinating, and submitting regulatory applications and correspondence to the Institutional Review Board (IRB), Food and Drug Administration (FDA), and other oversight committees, including initial reviews, modifications, continuing reviews, reportable events, and study closures. The RRC exercises independent judgment and critical thinking in the interpretation and application of regulatory requirements, protocol specifications, and institutional policies to support compliant and efficient study conduct.

The RRC is responsible for proactively shepherding studies through the regulatory review and activation process, identifying and resolving barriers to activation, and coordinating with investigators, sponsors, study teams, and ancillary departments to support timely study start-up and ongoing regulatory compliance. The incumbent serves as a regulatory subject matter expert for assigned studies and maintains effective working relationships with sponsors, governing agencies, investigators, monitors, and internal stakeholders.

In addition, the incumbent facilitates communication with National Clinical Trials Network (NCTN) groups, pharmaceutical companies, cooperative groups, and other research entities as needed. The RRC supports audit and inspection readiness by maintaining accurate and complete regulatory documentation in accordance with Good Clinical Practice (GCP), institutional policies, and sponsor requirements.

The incumbent is responsible for maintaining accurate regulatory information within the clinical trial management system (OnCore), the eRegulatory system (Florence) and ensuring compliance with institutional reporting requirements and external Cancer Center Support Grant (CCSG) guidelines established by the National Cancer Institute (NCI).

POSITION INFORMATION

• Salary or Pay Range: $ 34.62 - $55.67
• Salary Frequency: Hourly
• Salary Grade: 101
• UC Job Title: CLIN RSCH CRD
• UC Job Code: 009335
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100
• Shift (Work Schedule): 8am-5pom
• Location: Facilities Support Srvcs Bldg (HSP068)
• Union Representation: RX-Research Professionals
• 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.

Position requires working closely with caregivers and with patients who have a terminal illness; position may require working occasional overtime as work demands and to travel on occasion for training and educational purposes.

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.