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Overview

We are seeking a Biosample Operations Associate or Senior Associate based in the United States to support the operational management of biospecimens collected during clinical trials throughout their complete lifecycle. This role plays a critical function in ensuring precise tracking, proper documentation, and smooth transfer of clinical samples, while maintaining compliance with regulatory standards.

Key Responsibilities

Manage and coordinate all biospecimen-related activities across clinical studies, including collection, shipment, receipt, processing, storage, and transfer workflows.
Ensure thorough chain-of-custody documentation is maintained, with rigorous tracking of sample records across clinical sites, laboratories, and internal systems.
Support inventory control through sample reconciliation and development of study-specific tracking tools and reports.
Serve as the main operational liaison for central and specialty laboratories as well as external vendors to manage sample logistics and meet study needs.
Review laboratory paperwork, transfer logs, and inventory reports, addressing discrepancies, delays, missing samples, or quality concerns.
Conduct reconciliation of biosample data among clinical systems, laboratory databases, and sponsor tracking platforms to ensure consistent data accuracy.
Assist in audit and inspection preparation by maintaining comprehensive biosample documentation and operational records.
Collaborate cross-functionally with Clinical Operations, Clinical Development, Translational Medicine, Data Management, Regulatory Affairs, and external partners to enhance sample management processes.
Contribute to the development and refinement of biosample handling procedures, SOPs, and operational frameworks to support scalability.
Identify and implement improvements to increase efficiency, enhance visibility, and optimize vendor performance within clinical sample operations.

Candidate Profile and Requirements

Bachelor’s degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a related scientific field.
Between 2 to 5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a similar domain.
Preferred experience working with central laboratories, specialty testing labs, CROs, or clinical trial vendors.
Comprehensive understanding of clinical trial biosample workflows, including collection, processing, storage, shipment, tracking, and maintaining chain-of-custody.
Familiarity with International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and clinical trial operational procedures.
Skills in sample reconciliation, logistics coordination, and vendor management.
Exceptional attention to detail paired with strong documentation, organizational, and prioritization abilities.
Capability to independently manage multiple projects and shifting priorities in a dynamic, fast-growing biotechnology setting.
Effective communication and stakeholder engagement skills, facilitating collaboration across technical and non-technical teams.
Analytical thinker with solid problem-solving skills and experience resolving operational challenges.
Proficient in Microsoft Office suite; experience with clinical trial management systems, laboratory platforms, or sample tracking software is advantageous.
Exposure to biomarker, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, genomics, or translational medicine sample programs is beneficial.
Experience in biotechnology or pharmaceutical environments and familiarity with Laboratory Information Management Systems (LIMS) is preferred.

Benefits

Competitive annual salary ranging from $104,000 to $125,000 for Associate level and $130,000 to $146,000 for Senior Associate level positions.
Comprehensive benefits package and performance-based bonus opportunities.
Equity participation options.
Flexible remote work model or hybrid arrangements for candidates near company offices.
Opportunity to contribute directly to innovative clinical development initiatives within a growing biotechnology environment.
Supportive and inclusive team culture emphasizing collaboration, growth, and professional development.
Chance to develop expertise while helping to establish scalable operational processes.
Comprehensive employee benefits covering health, financial wellness, and work-life balance.

Additional Information

This position is offered through our partner company who independently manages applications and recruitment processes. The hiring decisions and next steps are handled directly by the partner. Our platform uses AI-driven tools to help quickly and fairly evaluate candidates, but all final hiring decisions are made by human teams. The role offers full-time employment with remote flexibility across the United States.

Biosample Operations Associate / Senior Associate