Research Associate, Cell Biology - Biomarker Operations

Gilead Sciences•Santa Monica, CA

About The Position

The Research Associate, Biomarker Operations supports biomarker and biospecimen activities across global oncology clinical trials, with a primary focus on Multiple Myeloma and hematologic malignancies. The role coordinates sample collection, tracking, shipment, testing, and data reconciliation in collaboration with Translational Medicine, Clinical Operations, clinical study teams, and external laboratory vendors. It contributes to high-quality biomarker operations throughout the clinical trial lifecycle by managing biospecimen workflows, supporting laboratory vendors, maintaining study documentation, and enabling study startup and ongoing trial execution. The role also uses AI-enabled tools, automation, analytics, and other digital technologies to streamline routine tasks, improve sample management and data quality, support vendor oversight, enhance reporting, identify operational risks, and inform study decisions. The position contributes to continuous improvement and operational innovation across biomarker programs.

Requirements

High school degree and 3 years of relevant experience, or an associate degree and 2 years of relevant experience; alternatively, a bachelor's degree is listed as a basic qualification.
Strong organizational skills and attention to detail.
Ability to manage multiple priorities in a fast-paced environment.
Strong verbal, written, and interpersonal communication skills.
Strong project coordination and organizational skills, attention to detail and data accuracy, and a proactive problem-solving mindset.
Ability to collaborate across functions and manage stakeholders and vendors.
Ability to work independently while managing competing priorities.
Digital and AI fluency, with interest in process improvement and operational innovation.

Nice To Haves

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, such as Microsoft Copilot, Power BI, Smartsheet, Jira, or Monday.com.
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.

Responsibilities

Support end-to-end biospecimen operations for global oncology clinical trials.
Track specimen collection, processing, shipment, receipt, testing, and storage.
Reconcile sample inventories and help resolve sample-related queries and discrepancies.
Monitor shipments and coordinate issue resolution with sites, laboratories, and vendors.
Maintain specimen tracking databases and study-specific sample management tools, including accurate documentation and chain-of-custody records.
Assist with developing and reviewing laboratory manuals, collection guidelines, and sample-handling instructions.
Review protocols and Schedules of Assessments to identify biomarker collection and testing requirements.
Support study startup, including laboratory vendor setup, sample logistics planning, and site training.
Participate in study team meetings and biomarker operational discussions.
Support implementation of biomarker strategies and sample management plans across studies.
Coordinate sample transfers and testing requests with central laboratories, specialty testing laboratories, and biorepositories.
Track laboratory deliverables, sample status, and turnaround timelines; identify, communicate, and escalate operational risks and issues.
Collaborate with vendors to ensure compliance with study requirements and timelines.
Support biomarker data reconciliation and maintain study documentation, sample transfer records, operational trackers, and status reports.
Assist with generating sample metrics, dashboards, and study updates while ensuring documentation complies with SOPs, GCP requirements, and applicable regulatory standards.
Use AI-enabled tools, automation, analytics, and digital solutions to improve sample tracking, vendor oversight, operational reporting, and workflow efficiency.
Develop and maintain dashboards, metrics, and performance reports to support clinical trial execution and decision-making.
Contribute to continuous improvement initiatives through adoption of AI and digital technologies.