Clinical Research Coordinator (PRIMED)

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

• Bachelor's 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.

Physical Requirements:
The physical demands described here are representative but not definitive of those that must be met by an employee to successfully perform the essential functions of this job.

• The position requires alternative sitting and standing throughout the working hours, withoccasional reaching and bending.
• Frequent handling of clinical and laboratory instruments requires the incumbent topossess sufficient motor neuron function to execute movements essential to performingsample collection and laboratory processing.
• Frequent telephone and computer use, including keyboard and mouse.
• The work environment involves exposure to hazards or physical risks, which require the following safety precautions (OSHA training provided).
• Occasional lifting up to 25 Ilbs.

Hiring Range: $26.76 - $35.45 per hour. We consider factors such as, but not limited to, scope and responsibilities of the position, candidate's qualifications, internal equity, as well as market and organizational considerations when extending an offer.

Background Check Statement:
All applicants who receive a conditional offer of employment are required to execute a release and authorization for a background screening.

AB 810 Misconduct Disclosure Requirement: University of the Pacific complies with California Assembly Bill 810, requiring candidates accepting conditional job offers to disclose any final administrative or judicial findings, ongoing proceedings, allegations, resignations under investigation, or appeals related to sexual harassment or misconduct within the past seven years.



To apply, visit https://pacific.peopleadmin.com/postings/31387









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