About this 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.
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.
- 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.