University Health Partners of Hawai'i (UCERA)

Clinical Research

• Support the UHP CEO and CMO in the development of a strategic approach to supporting and growing clinical and translational research within UHP
• Assess scientific merit of clinical and translational research proposals
• Foster collaborative clinical and translational research within UHP environment
• Serve as a liaison for use of UH infrastructure grants
• Foster the development of research infrastructure within UHP
• Complies with all legal requirements and company policies
• Performs all other duties as assigned

Director of Clinical Research

• Uphold regulatory standards (state, federal, accreditation), perform quality control, and maintain safety protocols.
• Ensure strict adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all relevant local, state, and federal regulatory requirements (e.g., CLIA, OSHA).
• Manage daily lab activities, ensure accurate & timely testing/sample processing, implement new procedures, and maintain smooth operations.
• Oversees the development and continual revision of laboratory SOPs for clinical trial-specific procedures.
• Supervise, hire, train, schedule, and conduct performance reviews for lab technicians and scientists.
• Ensure all lab staff are compliant with mandatory trainings required by DFCI, NIH and sponsor(s).
• Assists PI with counseling, teaching, training, mentoring, orientation, in-service, and continuing education for laboratory staff and trainees.
• Serves as a liaison role with principal investigators and study coordinators.
• Manage lab budget, order supplies, maintain equipment, and oversee vendor/reference lab relationships.
• Ensure data accuracy, manage patient/sample tracking, and prepare performance reports via the use of a Laboratory Information Management System (LIMS).
• Receive, log, process, and store biological specimens in accordance with clinical trial protocols, maintaining the integrity and chain of custody for all samples.
• Oversee equipment maintenance, calibration, and validation, including quality assurance.
• Troubleshoot technical issues as necessary.
• Participate in internal and external quality assurance and proficiency testing programs.
• Monitor and manage laboratory supply inventory, including ordering, receiving, and rotating reagents and consumables to prevent shortages or expiration.
• Prepare and ship specimens to central or external laboratories following IATA (International Air Transport Association) or other required regulations.
• Oversee the performance of routine and specialized laboratory assays, tests, maintenance, and analyses accurately and efficiently as defined by the study-specific protocol.
• Communicate promptly with UHCC leadership and clinical research staff regarding SOP management, protocol deviations, or unexpected test results.
• Complies with all legal requirements and company policies.
• Performs all other duties as assigned.

Director of Clinical Research

Early Phase Clinical Research Center Lab Manager