Pharmacokinetic Sampling Department Technician-Senior
San Antonio, TX, USA
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.
Benefits Overview
- Front-loaded Paid Time Off: 128 to 208 hours (16 to 26 days) of Paid Time Off based on years of service, given at the start of each fiscal year. PTO may be prorated in year one based on date of hire.
- Extended Illness Bank: 8 hours (1 day) accrued per month which can be used for illness or injury after one day of Paid Time Off is taken.
- Paid Family Leave: Up to 240 hours (6 weeks) to care for a spouse, child, or parent after 6 months of consecutive employment.
- Holidays: 12 set paid holidays each year.
None
- 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.
- 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.