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Position Summary

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

The Lab Services Lead Coordinator will function independently as the sole technologist 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 SOP’s
• 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

Bachelor’s Degree in Biological Sciences, Health related Sciences or equivalent combination of education and experience. 3 years of relevant laboratory experience required.

Clinical Laboratories / Lab Services - Individual Contributor - Specialized - S4 Consultant

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Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

The university is an equal opportunity employer, including veterans and disability.