Pharmacokinetic Sampling Department Technician-Senior

Independently manages biospecimen operations for complex, high-acuity, early-phase, or specialized clinical trials and serves as an advanced technical resource. Resolves complex specimen and logistics issues, provides quality review, mentors less-experienced staff, and contributes to laboratory readiness, standardization, and process improvement.

Typical schedule: 10:00 am to 7:00 pm with occasional shifts extending to 10:00 pm based on operational needs. Flexibility to work evening hours is required.

• Prepares and processes human specimens as specified by protocol for clinical trials and sponsor stipulations.

• Ensures consistent integrity and accuracy in specimen handling and processing.

• Processes and ships central laboratory specimens and maintains documentation.

• Records specimen information and data in requisition and tracking system.

• Prepares, receives, labels, documents, and stores all laboratory supplies received for clinical trials.

• Reconciles flow sheets with incoming specimens verifying accuracy of information.

• Flies copies of requisition and special study sheets.

• Prepares, receives, labels, documents, and ships specimens for transport to appropriate laboratories in a timely basis.

• Processes and ships fresh and archival biopsy samples as directed by the protocol or lab manual.

• Delivers archival blocks and slides for preparation as necessary.

• Responds to pharmacokinetic questions/issues arising from research nurses, CRA, and pharmaceutical companies in a timely manner.

• Will be required to taring lower level staff on continued responsibilities.

• Performs all other duties as assigned.

• Ability to demonstrate and apply in-depth knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.

• Ability to interact respectfully with other employees, professional staff and/or external contacts to offer ideas, identify issues, obtain information or deliver services.

• Excellent verbal, written and interpersonal communication skills.

• Proficiency with Microsoft Office and ability to access, enter, and interpret computerized data/information.

• Ability to work on projects or work groups, creating a collaborative and respectful team environment and improving workflows.

Knowledge, Skills, and Abilities:

• Advanced knowledge of clinical trial biospecimen collection, processing, storage, stability, packaging, shipping, chain of custody, and documentation requirements.
• Ability to interpret complex protocols, laboratory manuals, schedules of events, and sponsor instructions and translate them into clear processing workflows.
• Ability to independently manage complex pharmacokinetic, pharmacodynamic, biomarker, tissue, and other time-sensitive specimen requirements.
• Advanced troubleshooting skills involving collection timing, processing deviations, equipment, temperature, specimen integrity, couriers, and sponsor laboratories.
• Ability to assess operational and compliance risk, determine appropriate escalation, and coordinate corrective or preventive actions.
• Advanced organizational and prioritization skills for high-volume or high-acuity workloads with overlapping processing windows.
• Ability to perform quality reviews, identify trends, and recommend sustainable process improvements.
• Ability to train, mentor, and provide functional guidance to less-experienced staff without formal supervisory authority.
• Advanced proficiency with laboratory equipment, specimen-tracking, shipping, clinical research, inventory, and reporting systems

EDUCATION:

An associate’s degree in a related field is required.

EXPERIENCE:

Five (5) years of progressively responsible laboratory, biospecimen, clinical research, healthcare, or related experience is required.

LICENSES/CERTIFICATIONS:

None.