Biosample Operations Associate/Sr. Associate

Oruka Therapeutics•Waltham, MA

4h•$104,000 - $146,000•Hybrid

About The Position

Oruka Therapeutics is seeking a Biosample Operations Associate/Senior Associate to support the operational management of clinical trial biospecimens throughout their lifecycle. This role acts as the main point of contact between investigative sites, central laboratories, specialty testing laboratories, clinical operations, and study vendors to ensure accurate tracking, transfer, reconciliation, and documentation of clinical trial samples. The position 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. While not directly handling specimens, the role requires close collaboration to ensure sample integrity, regulatory compliance, and data quality. As part of a growing biotechnology company, this individual will be instrumental in building, optimizing, and scaling biosample operational processes, comfortable in a dynamic environment, identifying improvements, and establishing best practices for an expanding clinical development portfolio.

Requirements

Bachelor's degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a related scientific discipline required.
2–5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a related field.
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.

Nice To Haves

Experience working with central laboratories, specialty testing laboratories, CROs, or clinical trial vendors preferred.
Experience with sample reconciliation, logistics coordination, and vendor management preferred.
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.

Responsibilities

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.
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.
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.
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.