Clinical Trials Anatomic Pathology Specialist
The Anatomic Pathology Clinical Trial Specialist will assess the capacity and resources of Anatomic Pathology to handle the trial, assure that all projects are meeting assigned deadlines, and provide oversight of procedural accuracy. In addition the Clinical Trial Specialist will be responsible for digital pathology productivity.
STATUS: Full Time
LOCATION: Unity Professional Office Building
DEPARTMENT: Clinical Trials Anatomic Pathology
- Bachelor’s degree required, or 2-4 years of relevant laboratory experience, clinical trials experience desirable
- NYS licensure as a Histotechnician or NYS licensure as a Clinical Laboratory Technologist is preferred
- Experience in a histology lab required
- Sales Support. Review all anatomic pathology clinical trial requests and determine ability of the department to handle the trial. Review clinical protocols and Request For Proposal (RFP) materials upon receipt to determine pricing and Proposal strategy. Ensure all Proposal generation for timely delivery to clients; interact with clients and participate in defense meetings, as required. Investigate testing requirements to identify required testing and associated nuances for the timely and accurate response for Clinical Trials Scientific Affairs (CTSA)/CT Proposals. Provide scientific/technical information to compile client Request for Information (RFI). Liaise with sales staff to participate in client teleconferences to address new business needs or ongoing study issues. Provide consultation to clinical trials operations and external clients as needed.
- Trial Oversight. Understand all aspects of the trial and impacts on resources. Provide oversight of all aspects of the trial to ensure all procedural aspects are met including documentation and storage of all materials. Investigate Incident Reports, Action Items and Clinical Trials Actions and implement corrective action as needed. Collect data required for Quality Assurance monitors. Participate in all quality audits and inspections pertaining to trials. Work cooperatively with all department personnel to understand the overall capability of completing the clinical trial. Investigate issues during the life cycle of Pathology studies.
- Laboratory. Result data entry and verification in Laboratory Information System. Understand and follow company policies and procedures while always maintaining patient confidentiality, both inside and outside of the work place. Investigate and implement corrective actions as needed. Labels slides and cassettes. Perform visual QC on specimens. Distribute slides to the designated pathologist for interpretation. Send specimens to Clinical Trials Specimen Management (CTSM) for long-term storage. Demonstrate working knowledge of Lab Information System (LIS). Make suggestions to Supervisor/Manager for improved work methods and ways to increase efficiency, reduce costs, and solve operational problems. Work with Supervisor/Manager to update SOPs as needed. Assume responsibility for channeling information to and from Laboratory Operations. Ensure personal compliance with corporate policies, department policies and procedures, state, federal and FDA regulations. Exercise independent judgment, responsibility and problem-solving ability in daily work, and develop new laboratory procedures as directed by the Division Supervisor. Participate in CME and maintain appropriate certification & licensure if applicable.