You’ll need
Education
✓An associate’s degree in a related field is required.
Qualifications
✓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.
✓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
✓Five (5) years of progressively responsible laboratory, biospecimen, clinical research, healthcare, or related experience is required.
About the role
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.
What you’ll do
Records specimen information andRecords specimen information and data in requisition and tracking system
Reconciles flow sheets withReconciles flow sheets with incoming specimens verifying accuracy of information
Flies copies of requisitionFlies copies of requisition and special study sheets
Will be required toWill be required to taring lower level staff on continued responsibilities