Clinical Research Coordinator; PRIMED

Position Summary

Under the guidance of the Associate Director at the Center for Innovation and Translation, the Clinical Research Coordinator (CIT) will provide essential operational and administrative support for the PRIMED program, funded by the National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR). The Coordinator will coordinate all phases of clinical research projects‑from study documentation creation, regulatory preparation, through participant recruitment, data and sample collections, ongoing documentation and compliance monitoring to study closeout and reporting.

The Coordinator will also support the delivery of clinical research education programs and maintain communication with internal and external stakeholders.

The position is supported until August 2028; it may be extended if sustainable funding sources are identified.

• 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 REDCap 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 within grant budgets.
• Track purchases, manage supply inventory, and coordinate procurement of study materials.
• Support preparation of budget justifications and documentation.
• Support for CIT Projects.
• Contribute to additional innovation, pilot, or commercial research projects led by the Center for Innovation and Translation.
• Support documentation, meeting coordination, data entry, and stakeholder communication as needed.

• 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.

• 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., REDCap), including data entry, tracking, and reporting.
• Intermediate proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).

• 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.
• Manag…