POSITION SUMMARY
The Lab Manager plays a critical role in supporting clinical research trials and contributing directly to the research outcomes at the UH Cancer Center Early Phase Clinical Research Center (EPCRC) by being primarily responsible for the direction and supervision of all aspects of the Clinical Laboratory. This includes the supervision of accurate and compliant handling, processing, and storage of biological specimens according to strict clinical trial protocols and regulatory standards (GCP, CLIA). The Lab Manager ensures the management and integrity of the sample chain of custody, executes various lab assays efficiently, maintains essential laboratory equipment, and meticulously documents all activities to ensure the reliability and quality of research data. This role requires exceptional attention to detail, adherence to safety protocols, and effective communication with the clinical research team.
ESSENTIAL JOB DUTIES AND FUNCTIONS
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. Ensures 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.
QUALIFICATION REQUIREMENTS
Education/Training/Experience
Minimum:
Master’s Degree in a chemical, physical, or biological science, or medical laboratory technology from an accredited institution
Three years of laboratory experience, preferably in a clinical research, academic, or hospital laboratory setting.
Three years postgraduate experience in molecular biology, cellular biology, cancer biology, or a related discipline.
One year of supervisory experience
Preferred:
MD, DO, PhD, or equivalent Doctorate in a chemical, physical, or biological science, or medical laboratory technology from an accredited institution.
BENEFITS