Lab Services Lead Coordinator - Clinical Trials Processing Lab

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Job Title:

Lab Services Lead Coordinator - Clinical Trials Processing Lab

Department:

CCC | Clinical Trials Processing Lab

Position Summary

Lab Services Lead Coordinator reports to the Clinical Trial Processing Lab (CTPL) Lab Manager; supports all activities of the CTPL by functioning as an integral part of a team in a multi-disciplinary lab and provides strategic oversight and support to investigators across OSUWMC and outside of The Ohio State University.

• Either leads team of clinical lab technologists or functions independently as the sole technologist at a satellite CTPL laboratory location

• Oversees and manages, under the guidance of the Lab Manager, CTPL operations and workflows, including sample processing, storage and shipping in compliance with all applicable regulations and institutional policies

• Constructs sample libraries of many sample types including, but not limited to, blood, bone marrow, plasma, serum, urine, saliva and paraffin embedded tissue

• Receives, processes and distributes specimens, including time-sensitive patient samples for pharmacokinetic, pharmacodynamics and other correlative studies

• Manages sample and kit inventory via electronic database

• Completes laboratory test requisition forms and maintain samples records for audit purposes

• Oversees compliance with all safety standards and uses prescribed laboratory methods, instruments and automated equipment

• Trains staff on proper use of manual and automated equipment and maintains instrument maintenance records

• Reviews, prioritizes and assists in the design and implementation of new lab policies as needed

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

• Leads collaborations with clinical research and hospital staff as necessary, ensuring seamless integration with clinical operations

• Directs quality control and assurance activities, audits and FDA inspections

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

• Maintains all GCP, IATA, EHS and sponsor-required training and certifications

• Oversees onboarding and training of new technologists, research assistants and student assistants

• Serves as CTPL technical expert, provides guidance on complex projects, helps to develop and implement new processes

Job Requirements

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

Good working knowledge of laboratory principles, equipment and safety standards required; must be able to effectively communicate face to face and in writing with clinical staff and outside collaborators; experience processing tissue, blood, urine, saliva, and bone marrow samples, handling bio-hazardous materials and aseptic techniques preferred; data collection and data entry experience required; knowledge of tissue procurement techniques and anatomic pathology desi