Clinical Samples Operations Specialist

Seeking a Clinical Samples Operations Specialist to support the planning and coordination of operational activities related to the collection, shipment, storage, tracking, and testing of clinical biomarker and diagnostic samples from clinical trials. This individual will collaborate with internal clinical teams, external vendors, CROs, and clinical sites to ensure efficient sample management and data delivery in support of Translational Medicine and Clinical Pharmacology programs.

Key Responsibilities

• Manage clinical sample operations activities for translational sciences studies, including laboratory manual development, sample collection processes, and shipping logistics.

• Provide operational input to clinical study protocols and informed consent documents related to sample collection and handling.

• Track clinical samples and monitor timelines for testing, analysis, and data transfer.

• Coordinate sample transfers and resolve sample-related discrepancies with internal teams, vendors, CROs, and clinical sites.

• Support vendor selection, budget planning, and operational oversight for sample management activities.

• Oversee sample shipment logistics from clinical sites to bioanalytical and testing laboratories.

• Ensure appropriate documentation and records are maintained for sample collection, shipment, storage, transfer, and disposition.

• Review vendor invoices and provide budget estimates related to Translational Medicine and Pharmacokinetic (PK) sample activities.

• Coordinate sample storage, retention, and destruction activities in collaboration with internal stakeholders.

• Identify and communicate operational risks, issues, and mitigation plans related to clinical sample management.

Qualifications

Required

• Bachelor’s degree or equivalent combination of education and relevant experience.

• 3-4 years of experience in clinical sample management, clinical operations, laboratory operations, or a related field.

• Strong organizational skills with the ability to manage multiple priorities and timelines.

• Excellent attention to detail and problem-solving abilities.

• Proficiency with Microsoft Excel, PowerPoint, and other standard business software.

• Strong written and verbal communication skills.

• Ability to collaborate effectively with cross-functional teams and external partners.

Preferred

• Experience supporting biomarker, translational medicine, pharmacokinetic (PK), or clinical research sample operations.

• Experience working with CROs, central laboratories, and clinical trial vendors.

• Knowledge of GCP and clinical trial sample management processes.

The compensation range for this position is $45.00-$65.00 per hour. Actual compensation will be determined based on factors including skills, experience, qualifications, and business needs.