Temporary Assistant Regulatory Coordinator jobs in United States
cer-icon
Apply on Employer Site
company-logo

UC Irvine ยท 4 weeks ago

Temporary Assistant Regulatory Coordinator

UC Irvine is a prestigious public university known for its academic achievements and research contributions. The Temporary Assistant Regulatory Coordinator will support clinical research by managing regulatory documents and ensuring compliance with relevant regulations.

Higher Education
check
Diversity & Inclusion

Responsibilities

Prepare, collect, and maintain study regulatory documents required by the IRB, FDA, study sponsors, CROs, and PIs
Maintain study regulatory binders and ensure all documentation is appropriately filed and up to date in collaboration with study staff
Ensure all regulatory aspects of studies are current and accurately reflected in OnCore
Organize and facilitate study-related meetings, including scheduling, sending invitations, taking notes, and managing follow-up items

Qualification

Clinical research supportRegulatory coordinationOnCore familiarityIRB submissionsOrganizational skillsMeeting coordinationReport preparationRegulatory requirements understandingEnglish proficiencyAttention to detail

Required

Experience supporting clinical research, regulatory coordination, or similar administrative work within a research or healthcare setting
Strong organizational skills with meticulous attention to detail for managing documents and compliance requirements
Ability to manage multiple deadlines, coordinate schedules, and support ongoing study activities with minimal supervision
Ability to read, write, and follow written and oral instructions in English

Preferred

Previous experience working with IRB submissions, FDA-regulated studies, or clinical trial documentation
Familiarity with OnCore or other clinical trial management systems (CTMS)
Experience taking meeting minutes, preparing reports, and coordinating with CROs or study sponsors
Understanding of regulatory requirements for clinical research and human subjects protections

Benefits

Medical insurance
Sick and vacation time
Retirement savings plans
Access to a number of discounts and perks
Paid vacation
Holidays
Sick leave

Company

UC Irvine

company-logo
UC Irvine

Funding

Current Stage
Late Stage

Leadership Team

leader-logo
Anand Gala
CEO Roundtable Member
linkedin
leader-logo
Bob Romney
Chancellor's CEO Roundtable
linkedin
Company data provided by crunchbase