Senior Clinical Research Operations Associate, Oncology

Senior Clinical Research Operations Associate, Oncology

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 focused on day-to-day clinical study operations, project management, data quality oversight, and sample logistics. This is a full-time on-site position and reports to the Associate Director of Clinical Affairs, Oncology.

• 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.

• 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.

• 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, Graph Pad Prism) for exploratory summaries.
• Experience with internal documentation, project management, or CRM tools such as Notion or Salesforce.
• Experience working in an open, collaborative, and empowering environment aimed at advancing molecular diagnostics.

At Billion To One , we offer a total compensation package including base pay, equity options, and a corporate bonus program. For this position, a total compensation package of $129,297 per year is offered, including a base pay range of $84,480 - $95,041 per year.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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Billion To One is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our QCT molecular counting technology enhances disease detection resolution using cell-free DNA. We are dedicated to transforming prenatal and cancer diagnostics and improving patient outcomes.