University of the Pacific · 4 months ago
Clinical Research Coordinator (PRIMED)
San Francisco, CA
Full-time
Onsite
Entry, Mid Level
$26.76/hr - $35.45/hr
2+ years expUniversity of the Pacific is seeking a Clinical Research Coordinator (PRIMED) to provide essential operational and administrative support for the PRIMED program funded by the NIH. The role involves coordinating all phases of clinical research projects, managing regulatory submissions, participant recruitment, and ensuring compliance with NIH guidelines.
EducationHigher EducationUniversities
No H1B
Responsibilities
Support the day-to-day management of the PRIMED program, including study setup, delivery, monitoring, and closeout
Coordinate timelines, track milestones, and ensure program compliance with NIH and institutional guidelines
Organize regular team meetings, take minutes, and track follow-up actions across investigators, staff, and partners
Assist in the drafting, formatting, and revision of study protocols and informed consent documents
Coordinate development of regulatory packets for IRB submission, including protocol, consent forms, HIPAA, and recruitment materials
Prepare and maintain essential study documents including the Investigator Site File (ISF), regulatory binders and, participant tracking logs
Design and manage electronic and/or paper-based CRFs, ensuring alignment with protocol objectives and data analysis plans
Maintain RED Cap or other research databases, ensuring data integrity, security, and version control
Track data collection and monitor study progress against recruitment and reporting targets
Coordinate participant screening, enrollment, consent, and participant scheduling
Support sample collection, processing, and transfer in collaboration with lab and clinical personnel
Conduct or oversee quality checks on study data and sample integrity
Conduct internal audits of study files, CRFs, and regulatory documents to ensure protocol adherence
Coordinate organization and tracking for PRIMED training programs
Track completion and outcomes across student, resident, faculty, and alumni cohorts
Process program-related expenses and reimbursements grant budgets
Track purchases, manage supply inventory, and coordinate procurement of study materials
Support preparation of budget justifications and documentation
Contribute to additional innovation, pilot, or commercial research projects led by the Center for Innovation and Translation
Assist in developing outreach materials and maintaining contact with alumni and clinical sites for Practice Based Research Network development
Communicate study opportunities and updates through coordinated messaging and event support
Qualification
Required
Clinical research protocols and procedures, including protocol development, site file setup, case report form creation, and regulatory documentation
Institutional Review Board (IRB) and Good Clinical Practice (GCP) compliance requirements
NIH policies and general grant-funded research operations
Data management tools and systems (e.g., RED Cap), including data entry, tracking, and reporting
Intermediate proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
Two years' experience in biology, life sciences, or healthcare administration
Bachelor's Degree
Coordinate complex clinical research studies from start-up through closeout, ensuring accuracy and compliance at each stage
Work independently and collaboratively in a team setting with a proactive, detail-oriented approach
Manage sensitive data, biospecimens, and documentation with high ethical and professional standards
Track and organize multiple workflows, deadlines, and communications across internal and external stakeholders
Learn and implement new digital tools, platforms, and processes for research operations
Position is full time, eight (8) hours per day, five (5) days per week
Occupational exposure to blood borne pathogens or biohazardous materials may reasonably be anticipated. Personal protective equipment will be provided to reduce or eliminate exposure to routine or limited infectious agents
Occasional travel required
Preferred
NIH grant administration procedures and compliance reporting
Clinical study lifecycle management, including protocol development, site activation, participant recruitment, and regulatory documentation
Sample handling and biobank protocol knowledge
Proficiency with RED Cap, IRB submission platforms (e.g., IRIS, i Med RIS), and data quality control practices
Familiarity with training program delivery in clinical research settings
3+ years of experience in clinical research operations, ideally in an academic or federally funded environment
Experience with IRB processes, informed consent development, CRF creation, and study file documentation
Familiarity with the implementation of training or education programs related to research
Prior use of RED Cap, SharePoint, and project tracking tools preferred
Degree in public health, clinical research, or biomedical sciences
Bilingual skills are helpful
Experience and sensitivity in working with people of diverse backgrounds and cultures
Demonstrated experience in advancing social justice, equity, and inclusion in a university setting
Ability to engage and integrate culturally responsive practices and knowledge in their work
Company
University of the Pacific
University of the Pacific is a private university dedicated to providing students with opportunities in the fastest-growing industries.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Wesley Yourth
Deputy Director of Athletics - Chief Operating Officer
Cari Keller
Director of HR Partner Services
Recent News
2025-07-14
University of the Pacific
2025-04-30
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