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.