Lead Lab Processing Technician - Clinical Trials Processing Lab

The Clinical Trials Processing Lab (CTPL) handles human fluid and tissue samples from patients enrolled in oncology clinical trials conducted by the James Cancer Hospital.

Position Summary

The Lead Lab Processing Technician will either lead a team of technicians or function independently as the sole technician at a satellite laboratory location of the CTPL within the Comprehensive Cancer Center.

Responsibilities

Helps 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

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

Prepares necessary supplies for specimen collection

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

Completes laboratory test requisition forms; maintain laboratory maintenance and sample records for audit purposes

Communicates with outside reference labs regarding patient testing, handle inquiries and resolve any testing and / or specimen collection errors

Interacts with clinical research protocol and hospital clinical staff

Participates 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

Manages sample inventory log and electronic database

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

Maintains 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

Job Requirements

Bachelors degree in biological science or medical laboratory / technology field or equivalent combination of education and experience. 1 year of relevant laboratory experience required.

Clinical Laboratories - Lab Services - Individual Contributor - Technical - T4 Lead