Clinical Research Coordinator (PRIMED)

Primary Purpose
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 Institute of Health ( NIH ) National Institute of Dental and Craniofacial Research ( NIDCR ). The Clinical Research 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. Key responsibilities include preparing regulatory submissions managing case report forms and site files facilitating training compliance maintaining study documentation supporting financial processing and contributing to NIH reporting requirements. The Coordinator will also assist with broader CIT led innovation clinical research and translational research projects as needed. The University of the Pacific recognizes that diversity equity and inclusion are foundational to the success of our valued students and employees. We prioritize policy and decision-making that demonstrates awareness of and responsiveness to the ways sociocultural forces related to race gender ability sexuality socioeconomic status etc. impede or propel students faculty and staff. The position is supported until August 2028; It may be extended if sustainable funding sources are identified.

Essential Functions
The Clinical Research Coordinator will play a pivotal role in executing the multifaceted PRIMED grant awarded by the NIH NIDCR . Collaborating closely with internal and external stakeholders including collaborators students research faculty clinical faculty and staff the incumbent will oversee various aspects of research support to ensure the successful delivery of PRIMED objectives. Program and Study Coordination 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. Regulatory and Documentation Oversight 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. Case Report Forms (CRFs) and Data Management 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. Clinical Study Support 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. Study Monitoring and Auditing Conduct internal audits of study files CRFs and regulatory documents to ensure protocol adherence. Training and Education Program Support Coordinate organization and tracking for PRIMED training programs. Track completion and outcomes across student resident faculty and alumni cohorts. Administrative and Financial Management 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. 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. Community and Research Engagement 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.

Minimum Qualifications
Knowledge of: 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). Ability to: 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. Experience: Two years experience in biology life sciences or healthcare administration. Education Bachelors Degree. Working Conditions: 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 Qualifications
Knowledge of: 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. Ability to: Assist with managing multiple studies including document control SOP development and quality checks. Coordinate logistics for education programs outreach events and faculty-student engagement. Communicate clearly and professionally with academic clinical and external partners. Maintain discretion professionalism and attention to compliance in all aspects of clinical research. Support study audits documentation review and data reporting to internal and external funders. Experience: 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. Education: Degree in public health clinical research or biomedical sciences. Other: 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.