Senior Clinical Research Operations Associate, Oncology

Ready to redefine what's possible in molecular diagnostics?

Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today. Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion—every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong.

We are seeking a detail-oriented Sr. Clinical Research Operations Associate to support the execution of oncology clinical studies within the Clinical Affairs team. The role is primarily focused on day-to-day clinical study operations, project management, data quality oversight, and sample logistics, with clear direction and mentorship provided by clinical leadership. The Sr. Clinical Research Operations Associate is a full-time on-site position and reports to the Associate Director of Clinical Affairs, Oncology.

Responsibilities:

• Manage day-to-day operations for oncology clinical studies, including study timelines, task tracking, cross-functional coordination, study start-up and close-out activities, and preparation of internal status reports and study materials.
• Support regulatory and IRB activities under supervision, including preparation and submission of IRB applications, amendments, continuing reviews, protocol deviations, and maintenance of regulatory documentation in compliance with GCP.
• Develop, maintain, and monitor REDCap databases, including database build aligned to study protocols, routine data quality review, discrepancy tracking, and follow-up with study teams to ensure clean, analysis-ready datasets.
• Coordinate biospecimen, laboratory, and biobanking operations, including sample collection, shipment, accessioning, tracking, and collaboration with laboratory teams to build, curate, and maintain oncology specimen biobanking procedures and databases.
• Provide operational and analytical support for clinical data and scientific outputs, including preliminary data review, literature summaries, and assistance with internal  analyses and development of scientific materials for presentations or publications.

Qualifications:

• Bachelor’s degree in a life science, public health, or related field with 2–3 years of hands-on clinical research coordination or clinical operations experience, or a Master’s degree (MPH or related) with 1–2 years of relevant clinical research experience.
• Working knowledge of IRB processes, informed consent, and Good Clinical Practice (GCP), with experience supporting submissions and ongoing study maintenance.
• Hands-on experience with clinical research database management (e.g., REDCap), including database build or maintenance, data entry oversight, and routine data quality review.
• Basic proficiency in SQL, and R or python for clinical data handling, including data cleaning, simple summaries, and generation of tables or figures for internal use ​​(advanced statistical modeling not required).
• Strong organizational, communication, and project management skills, with the ability to manage multiple concurrent tasks, work collaboratively in a cross-functional environment, and execute independently under direction.

Nice-to-Haves:

• Experience supporting oncology or translational clinical research, including biospecimen handling, sample tracking, or biobanking workflows.
• Familiarity with basic data analysis or visualization tools (e.g., R or other statistical programming, GraphPad Prism) for exploratory summaries.
• Experience with internal documentation, project management, or CRM tools such as Notion or Salesforce.

Benefits And Perks:

• Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future