Biosample Operations Associate/Sr. Associate
New
O
Oruka TherapeuticsBiotechnology
Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CAFull-TimeMiddle
Salary$104,000 - $146,000 USD
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Job Details
- Experience
- 2–5 years
- Required Skills
- Microsoft Office
Requirements
- Bachelor's degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a related scientific discipline.
- 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.
- 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.
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.
- Perform routine reconciliation of biosample data across laboratory databases, EDC systems, IRT systems, and sponsor tracking tools.
- Partner with cross-functional stakeholders including Clinical Operations, Biometrics, and Regulatory Affairs to support study startup and operations.
- Contribute to the development, implementation, and continuous improvement of biosample management processes, tools, and SOPs.
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