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.

Requirements

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

Generous time off benefits
100% employee health and dental coverage and vision
Flexible spending plan
Retirement plan with up to 3% dollar-for-dollar company matching contributions
100% company paid group Life/AD&D/LTD insurance
Employee assistance program (EAP)
Pet Insurance, Prepaid legal with competitive rates

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Good Clinical Practice (GCP)Standard Operating Procedures (SOPs)Laboratory Information Management System (LIMS)molecular biologycellular biologycancer biologylaboratory assaysquality assurancedata accuracysample processing

Soft Skills

supervisiontrainingmentoringcommunicationcounselingorganizational skillsproblem-solvingleadershipperformance reviewsliaison

Certifications

Master’s DegreeMDDOPhDaccredited institution certification