Histotech, Clinical Trials

The Histotechnologist, Clinical Trials supports testing activities within the Biopharma CDx Services CAP-CLIA laboratory for clinical trials. Testing personnel are responsible for specimen processing, test performance, and reporting test results.

Performs only high-complexity tests authorized by the laboratory director that are commensurate with the individual’s education, training, experience, and technical abilities.

This position applies advanced histology knowledge and technical expertise to perform laboratory activities, troubleshoot technical issues, maintain quality and compliance standards, and contribute to continuous improvement of laboratory processes.

• →Follow established laboratory procedures for specimen handling and processing, test analyses, and the reporting and maintenance of patient test results.
• →Independently perform complex histology laboratory activities within established procedures, regulatory requirements, and individual testing qualifications.
• →May perform IHC testing under the direct supervision of a qualified technologist, technical supervisor, or other qualified pathologist.
• →Prepare tissue specimens by sectioning and staining samples for microscopic analysis and perform staining procedures according to established guidelines.
• →Identify and troubleshoot technical issues that may adversely affect specimen quality, test performance, or reporting; take appropriate corrective action or immediately notify the general supervisor, technical supervisor, clinical consultant, or laboratory director as required.
• →Follow established policies and procedures whenever test systems are not within acceptable levels of performance and document all corrective actions when test systems deviate from established performance specifications.
• →Perform and document quality-control activities, instrument and procedural calibrations, preventive maintenance, and equipment maintenance/certification.
• →Maintain records demonstrating that proficiency testing samples are tested in the same manner as patient specimens.
• →Maintain the laboratory in a clean, functional, and inspection-ready state.
• →Contribute to laboratory quality initiatives and improvements to procedures, workflows, and operational processes.
• →Support ongoing CAP-CLIA inspection readiness and other applicable regulatory and quality activities.
• →Serve as a technical resource within the laboratory and may provide training or guidance to less-experienced laboratory personnel.
• →Maintain appropriate filing and storage of completed tissue blocks and slides.
• →Plan, coordinate, and prioritize assigned laboratory activities with minimal direction while working within established procedures and regulatory requirements.

• Bachelor’s degree in one of the chemical, physical, or biological sciences, or a related discipline that meets applicable CLIA requirements for testing personnel.
• Typically 4+ years of relevant laboratory experience, including experience in histology, histotechnology, or a closely related laboratory environment.
• Histotechnologist HTL(ASCP) or Histotechnician HT(ASCP) certification.
• Demonstrated ability to perform laboratory activities with minimal direction, identify and troubleshoot technical issues, and work effectively within established quality and regulatory procedures.
• Experience working in a CLIA-regulated laboratory is desired.