Job Title: Biosample Operations Associate

Location: Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.

Role Overview:

The Biosample Operations Associate is responsible for supporting the operational management of clinical trial biospecimens throughout the sample lifecycle. This role serves as the primary liaison between investigative sites, central laboratories, specialty testing laboratories, clinical operations, and study vendors to ensure the accurate tracking, transfer, reconciliation, and documentation of clinical trial samples.

The Biosample Operations Associate/Senior Associate oversees chain-of-custody processes and sample logistics from collection at clinical sites through shipment to central laboratories and onward transfer to specialty or third-party testing laboratories. This position does not involve direct handling of biological specimens but requires close collaboration with internal and external stakeholders to ensure sample integrity, regulatory compliance, and data quality.

As a member of a growing biotechnology company, this individual will play a key role in building, optimizing, and scaling biosample operational processes. The ideal candidate is comfortable working in a dynamic environment, identifying process improvements, and helping establish best practices that support an expanding clinical development portfolio.

Key Responsibilities:

Biosample Lifecycle Management

• Coordinate and oversee biospecimen management activities across clinical studies.
• Monitor sample collection, shipment, receipt, processing, storage, and transfer activities performed by external laboratory vendors.
• Ensure complete and accurate chain-of-custody documentation throughout the sample lifecycle.
• Track sample inventories and reconcile sample records between investigative sites, central laboratories, specialty laboratories, and sponsor tracking systems.
• Support the development and maintenance of sample tracking tools, reports, and study-specific biosample management plans.

Laboratory and Vendor Management

• Serve as the primary operational contact for central laboratories and specialty testing laboratories regarding biosample logistics and study requirements.
• Coordinate sample transfers between laboratories to support biomarker, PK, PD, immunogenicity, genomic, and exploratory research testing.
• Review laboratory documentation, sample transfer records, and inventory reports for completeness and accuracy.
• Escalate and assist in resolving sample discrepancies, missing samples, shipment delays, temperature excursions, and chain-of-custody issues.
• Support oversight of laboratory vendors to ensure compliance with study requirements and timelines.

Data Reconciliation and Quality Oversight

• Perform routine reconciliation of biosample data across laboratory databases, EDC systems, IRT systems, and sponsor tracking tools.
• Investigate and document sample-related discrepancies and support corrective and preventive actions when necessary.
• Maintain biosample metrics and generate study status reports for cross-functional stakeholders.
• Support inspection and audit readiness by ensuring complete and accurate biosample documentation and records.

Cross-Functional Collaboration and Process Development

• Partner closely with Clinical Operations, Clinical Development, Translational Medicine, Biometrics, Data Management, Regulatory Affairs, and external vendors.
• Support study startup activities, including review of laboratory manuals, sample collection procedures, laboratory specifications, and sample flow requirements.
• Review study protocols and schedules of assessments to ensure biosample collection and testing requirements are operationally feasible and clearly defined.
• Contribute to the development, implementation, and continuous improvement of biosample management processes, tools, and SOPs.
• Identify operational efficiencies and recommend process enhancements to improve sample visibility, data quality, and vendor performance.
• Help establish scalable biosample operations infrastructure to support the company’s growing clinical development programs.

Qualifications:

Education

Bachelor's degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a related scientific discipline required.

Experience

• 2–5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a related field.
• Experience working with central laboratories, specialty testing laboratories, CROs, or clinical trial vendors preferred.
• Understanding of clinical trial biosample management processes, chain-of-custody requirements, and laboratory operations.
• Experience with sample reconciliation, logistics coordination, and vendor management preferred.

Knowledge and Skills

• Working knowledge of ICH-GCP guidelines and clinical trial operational requirements.
• Understanding of biospecimen collection, processing, storage, shipment, and tracking workflows.
• Strong organizational skills with exceptional attention to detail and documentation accuracy.
• Ability to manage multiple studies and priorities in a fast-paced biotech environment.
• Demonstrated ability to work independently and help build processes in a growing organization.
• Excellent communication and stakeholder management skills.
• Proficiency with Microsoft Office applications and clinical trial management, laboratory, or sample tracking systems.
• Strong analytical, problem-solving, and issue-resolution capabilities.

Preferred Qualifications

• Experience supporting biomarker, PK, PD, immunogenicity, genomic, or translational medicine sample programs.
• Experience in a biotechnology or pharmaceutical company environment, particularly within a small or emerging biotech.
• Familiarity with central laboratory data portals, sample inventory systems, and laboratory information management systems (LIMS).
• Experience supporting clinical studies from startup through study closeout.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for Associate level is $104,000 - $125,000.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.