Regulatory and Records Assistant

89408

Sacramento

Full Time

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.

10/24/2026 by 11:59pm PST

• 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 elevate 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.

• 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.

• 35% - IND Safety Report Processing
• 35% - OCR-Wide Records Retention and Archiving
• 25% - Centralized Regulatory and…