Regulatory and Records Assistant

Under the direct supervision of the Assistant Director, Regulatory Unit, the Regulatory and Records Assistant (RRA) supports centralized regulatory and records-management activities for the UC Davis Comprehensive Cancer Center Office of Clinical Research (OCR). Responsibilities include processing IND safety reports and other routine regulatory activities; maintaining central essential documents and tracking required reviews, signatures, and training documentation; and coordinating the organization, retention, archival, and retrieval of clinical research records across OCR functional units. The RRA performs assigned activities in accordance with applicable regulations, institutional policies, OCR standard operating procedures, and established workflows.

Apply By Date 10/24/2026 by 11:59pm PST

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 one (1) year of experience providing administrative, records-management, document-control, regulatory, or operational support in an environment requiring accurate recordkeeping, management of multiple deadlines, and handling of confidential or sensitive information.
• Working knowledge of standard office applications, including Microsoft Word, Excel, Outlook, and Teams, and ability to learn new electronic systems.
• Organizational and records-management skills sufficient to accurately maintain, retrieve, and track a high volume of physical and electronic records.
• Ability to follow written procedures, checklists, and multistep workflows consistently and within established timelines.
• Attention to detail sufficient to identify missing, incomplete, duplicate, expired, incorrectly assigned, or improperly filed documentation.
• Ability to accurately enter, review, and maintain information in electronic systems, databases, spreadsheets, and tracking tools.
• Ability to organize and prioritize multiple assignments, monitor deadlines, follow up on outstanding items, and communicate potential delays.
• Ability to distinguish routine activities from nonroutine issues and seek guidance or escalate concerns appropriately.
• Analytical and problem-solving skills to review information, identify discrepancies, and take appropriate action within established procedures.
• Written communication skills sufficient to prepare clear, accurate, and professional correspondence, status updates, and documentation.
• Oral communication and interpersonal skills to communicate effectively and professionally with investigators, research personnel, supervisors, colleagues, and institutional partners.
• Ability to work independently under general supervision and collaboratively as part of a diverse, multidisciplinary team.
• Ability to maintain confidentiality and appropriately handle sensitive participant, research, personnel, financial, and proprietary information.
• Ability to maintain accuracy and attention to detail while performing repetitive or high-volume work.
• Ability to adapt to changing priorities, procedures, systems, and workload demands.
• Ability to accept feedback, correct errors, and apply instructions consistently to future work.
• Ability to provide timely, courteous, and service-oriented support while maintaining established compliance and documentation requirements.

Preferred Qualifications

• Bachelor's Degree in related area.
• Experience providing administrative, regulatory, records-management, or document-control support in clinical research, healthcare, higher education, or another regulated environment.
• Experience processing a high volume of documents, monitoring deadlines, following up on outstanding requirements, and maintaining tracking tools.
• Experience organizing, reconciling, archiving, or retrieving physical or electronic records.
• Experience using an electronic document-management system, clinical trial management system, or other enterprise information system.
• Experience supporting clinical research regulatory documentation, safety-report processing, study closeout, or records-retention activities.
• Experience working in a cancer center, academic medical center, clinical trials office, or research program.
• Experience with Florence eBinders, OnCore, or comparable clinical research systems.

Key Responsibilities

• 35% - IND Safety Report Processing
• 35% - OCR-Wide Records Retention and Archiving
• 25% - Centralized Regulatory and Essential Document Support
• 5% - Quality, Systems, and Operational Support

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

Responsibilities include supporting centralized regulatory activities for cancer-related clinical research conducted through the OCR. The RRA processes IND safety reports, including identifying applicable studies and investigators, routing reports for required review or acknowledgment, tracking completion, maintaining documentation, and escalating exceptions requiring regulatory review. The RRA also processes continuing review approvals and permanent study closures to the NCI Central Institutional Review Board (CIRB) and provides other routine regulatory support as assigned.

The RRA maintains centralized essential documents, including medical licenses, curricula vitae, laboratory certifications, and required training documentation. The incumbent monitors document expiration dates and outstanding requirements; distributes reminders; collects, reviews, and files updated documentation; and follows up with investigators and research personnel to maintain complete and current records.

The RRA supports records retention and archival activities across OCR functional units by organizing, inventorying, transferring, retrieving, and tracking clinical research records in accordance with established procedures. The incumbent reviews records for basic completeness against established checklists, follows up on missing or incomplete items, maintains archival inventories and transfer documentation, and escalates questions involving retention requirements, substantive record completeness, or authorized disposition.

The incumbent accurately maintains regulatory and records-management information in applicable clinical research systems, including OnCore and Florence eBinders, and performs assigned responsibilities in accordance with applicable federal regulations, institutional policies, OCR standard operating procedures, and Cancer Center Support Grant requirements. The RRA independently completes routine activities using established workflows and refers nonroutine matters or questions requiring regulatory interpretation to senior regulatory staff or management.

POSITION INFORMATION

• Salary or Pay Range: $26.72 - $37.85
• Salary Frequency: Hourly
• Salary Grade: 109
• UC Job Title: BLANK AST 2
• UC Job Code: 004723
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100%
• Shift (Work Schedule): Monday -Friday, 8:00am - 5:00pm
• Location: Facilities Support Srvcs Bldg (HSP068)
• Union Representation: CX-Clerical/Admin
• 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 by visiting or or .

• High quality and low-cost to choose from to fit your family's needs
• UC pays for and coverage for you and your family
• for eligible employees including Pension and other Retirement Saving Plans
• Supplemental insurance offered including , , , , accident, critical illness and hospital indemnity
• , , and for eligible employees
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