Research Associate, Cell Biology - Biomarker Operations
Gilead Sciences · United States, California, Santa Monica
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Job Description
The Research Associate, Biomarker Operations supports the execution of biomarker and biospecimen activities across oncology clinical trials, with a particular focus on Multiple Myeloma and hematologic malignancies. This role partners closely with Translational Medicine, Clinical Operations, study teams, and external laboratory partners to coordinate sample collection, tracking, shipment, testing, and data reconciliation activities. The successful candidate will help ensure high-quality biomarker operations throughout the clinical trial lifecycle by managing biospecimen workflows, supporting vendor relationships, maintaining study documentation, and contributing to study startup and execution activities.
The individual will also leverage AI-enabled tools, automation, and data-driven technologies to streamline workflows, enhance operational efficiency, improve reporting and sample oversight, and support data-driven decision-making. The ideal candidate has experience in oncology clinical research, strong organizational and project coordination skills, digital and AI fluency, and a passion for advancing translational science through operational excellence, innovation, and continuous improvement.
The Research Associate, Biomarker Operations supports the execution of biomarker and biospecimen activities across global oncology clinical trials, with a primary focus on Multiple Myeloma and hematologic malignancies. This role partners closely with Translational Medicine, Clinical Operations, Clinical Study Teams, and external laboratory vendors to coordinate sample collection, tracking, shipment, testing, and data reconciliation activities.
The successful candidate will contribute to the execution of high-quality biomarker operations throughout the clinical trial lifecycle by managing complex biospecimen workflows, supporting laboratory vendors, maintaining study documentation, and enabling study startup and ongoing trial execution. In addition, this individual will leverage AI-enabled, automation, and digital technologies to enhance sample management, optimize operational workflows, support vendor oversight, improve reporting capabilities, and generate actionable insights that inform study decisions.
As part of an evolving AI-first operating model, this role will be expected to utilize tools such as Microsoft Copilot, advanced analytics platforms, workflow automation solutions, and data visualization technologies to streamline routine tasks, increase operational efficiency, improve data quality, identify risks proactively, and accelerate decision-making across biomarker programs.
Key Responsibilities
Biospecimen & Sample Management
- Support end-to-end biospecimen operations for global oncology clinical trials.
- Track specimen collection, processing, shipment, receipt, testing, and storage activities.
- Reconcile sample inventories and support resolution of sample-related queries and discrepancies.
- Monitor sample shipments and coordinate issue resolution with sites, laboratories, and vendors.
- Maintain specimen tracking databases and study-specific sample management tools.
- Ensure accurate documentation and chain-of-custody records throughout the study lifecycle.
Study Support
- Assist with the development and review of laboratory manuals, collection guidelines, and sample handling instructions.
- Support protocol and Schedule of Assessments reviews to identify biomarker collection and testing requirements.
- Participate in study startup activities, including laboratory vendor setup, sample logistics planning, and site training support.
- Contribute to study team meetings and biomarker operational discussions.
- Support implementation of biomarker strategies and sample management plans across multiple studies.
Vendor Coordination
- Serve as an operational point of contact for central laboratories, specialty testing laboratories, and biorepositories.
- Coordinate sample transfers and testing requests with vendors.
- Track laboratory deliverables, sample status, and turnaround timelines.
- Identify, communicate, and escalate operational risks and issues in a timely manner.
- Collaborate with vendors to ensure compliance with study requirements and timelines.
Data, Documentation & Reporting
- Support biomarker data reconciliation activities.
- Maintain study documentation, sample transfer records, operational trackers, and status reports.
- Assist with generation of sample metrics, dashboards, and study updates.
- Ensure documentation complies with SOPs, GCP requirements, and applicable regulatory standards.
AI-Enabled Operations & Innovation
- Leverage AI-powered tools and digital solutions to support study planning, sample tracking, vendor oversight, and operational reporting.
- Utilize automation and data-driven insights to improve biomarker workflow efficiency and proactively identify operational risks.
- Develop and maintain dashboards, metrics, and performance reports to support clinical trial execution and decision-making.
- Contribute to continuous improvement initiatives through the adoption of AI and digital technologies.
Basic Qualifications:
- High School Degree and 3 years of relevant experience
OR
- Associates and 2 years of relevant experience
OR
- Bachelor’s
Preferred Qualifications
- Experience supporting Multiple Myeloma, hematologic malignancy, cell therapy, or immuno-oncology clinical programs.
- Experience managing bone marrow aspirate and biopsy samples.
- Experience managing PBMC, serum, plasma, cfDNA, tissue, and other biomarker sample types.
- Experience working with central laboratories, specialty testing vendors, and biorepositories.
- Familiarity with GCP, GCLP, Laboratory Information Management Systems (LIMS), and clinical trial operational processes, including biospecimen tracking and inventory management.
- Advanced proficiency with Excel, sample tracking systems, and operational reporting tools.
- Experience using AI-enabled productivity, analytics, or project management platforms (e.g., Microsoft Copilot, Power BI, Smartsheet, Jira, Monday.com, or similar tools).
- Bachelor’s degree in biology, Molecular Biology, Immunology, Biotechnology, Clinical Laboratory Science, or a related scientific discipline.
- 1-4 years of experience in clinical research, biomarker operations, laboratory operations, biospecimen management, or a related field.
- Experience supporting oncology clinical studies.
- Familiarity with Multiple Myeloma clinical research and associated specimen types, including bone marrow and peripheral blood samples.
- Knowledge of biospecimen handling, processing, shipment, and laboratory testing workflows.
- Strong organizational skills and attention to detail.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong verbal, written, and interpersonal communication skills.
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Key Competencies
- Strong project coordination and organizational skills
- Attention to detail and data accuracy
- Proactive problem-solving mindset
- Cross-functional collaboration and stakeholder management
- Vendor management and communic