Lead Clinical Lab Technologist

Job Description

The CTPL handles human fluid and tissue samples from patients enrolled in oncology clinical trials conducted by the James Cancer Hospital.

The Lead Clinical Lab Technologist will either lead a team of clinical lab technologists or function independently as the sole technologist at a satellite laboratory location of the CTPL within the Comprehensive Cancer Center.

Responsibilities

• Oversee and manage all activities of the CTPL including preparing labels, labeling tubes for clinical trial specimen collection, specimen processing and storage, retrieving and shipping samples

• Use prescribed laboratory methods, instruments and automated equipment to process clinical patient samples

• Prepare necessary supplies for specimen collection

• Process time-sensitive clinical samples for pharmacokinetic, pharmacodynamic and other correlative markers as well as clinical safety labs

• Complete laboratory test requisition forms

• Maintain laboratory maintenance and sample records for audit purposes

• Communicate with outside reference labs regarding patient testing

• Handle inquiries and resolve any testing and/or specimen collection errors

• Interact with clinical research protocol and hospital clinical staff

• Participate in data entry and management, quality control, audits and FDA inspections

• Continuous quality improvement and inventory management of clinical trial specimens, trial and laboratory supplies

• Manage sample inventory log and electronic database

• Ensure compliance with FDA and IRB regulations as well as internal clinical research SOPs, policies and procedures

• Maintain all GCP, IATA, EHS and sponsor-required trainings and certifications

• Monitors and ensure periodic and routine maintenance of CTPL equipment

• Provides input in developing and revising departmental SOPs

• Participates in instruction and training of new clinical laboratory technologists and student assistants

• Serves as a CTPL technical expert

• Represents the CTPL during sponsor site qualification and monitoring visits

Minimum Education Required

Bachelors degree in biological science or medical laboratory/technology field or equivalent combination of education and experience.

Qualifications

1 year of relevant laboratory experience required.