Clinical Trial Specimen Management (CTSM) Technicians - Contract - Onsite
Proclinical Staffing is seeking a Clinical Trial Specimen Management (CTSM) Technicians to join a cutting-edge laboratory. This is a contract role located in Rochester, NY.
Primary Responsibilities
In this role, you will perform the daily operations of the Clinical Trials Specimen Management (CTSM) team according to company policies and procedures, interpret laboratory requisition forms and accurately enters all information into the applicable computer systems, prepare, maintain and log location of specimens in computer systems for short- and long-term storage. In addition, you will comply storage metrics and analyzes activity related to specimen storage. Handles and prepares Clinical Trials specimens for testing, shipping and/or storage, expedite the preparation of priority specimens, identify special service requests to meet requested turnaround time, prepare shipment of specimens in accordance with IATA regulations and protocol specifications, and maintain patient confidentiality both in and out of the workplace.
The Clinical Trial Specimen Management (CTSM) Technicians will:
- Understands and follows company policies and safety procedures to prevent the risk of blood and body fluid exposure.
- Interprets laboratory requisitions or manifests and accurately enters patient demographic and test information into appropriate computer systems as applicable for all Clinical Trials specimens. Expedites the preparation of priority specimens and shipments to meet the requested Turn Around Time (TAT) by sponsors or laboratory.
- Distributes specimens to appropriate department for prompt analysis as needed.
- Performs and documents disposal of previously tested stored specimens as needed.
- Obtains previously tested samples for additional testing initiated by Investigators/Sponsors. Performs QC process and manifest preparation for all stored specimens.
- Maintains specimen integrity for laboratory testing. Prepares, maintains and logs location of specimens in computer systems/databases for short and long term storage.
- Compiles storage metrics and analyzes all activity related to specimen storage.
- Documents discrepancies, investigates and initiates action items as needed. Notifies appropriate project team /department of problem resolution pertaining to specimen or subject demographic discrepancies.
- Prints referral manifests and packs specimens to deliver to reference laboratories.
- Prepares shipment in accordance with International Air Transport Association (IATA) regulations. Creates reports, manifest or invoices for specimen storage and shipping required documentation. Initiates shipping for domestic and international shipments.
- Catalogues stored specimens according to protocol specifications and participates in QC process and manifest preparation for all stored specimens.
- Assists with validations of new shipping or cataloguing systems. Assists with daily receipt of specimen packages.
- Performs and documents daily maintenance and monitoring functions, as required. (i.e.: specimen rotation, temperature documentation, pending list,)
- Interacts with Quality Assurance Auditors and Sponsor Auditors as needed.
- Performs all duties in compliance with the Food and Drug Administration, New York State Department of Health, Good Clinical Practice, International Air Transport Association and other pertinent regulations; is knowledgeable about U.S. and foreign shipping requirements and uses this knowledge appropriately when shipping and consulting with department personnel regarding specimen shipments.
Compensation:
$18.25 per hour
If you are having difficulty in applying or if you have any questions, please contact Jay Bastien at (+1) 857-254-1065 or j.bastien@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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