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We are seeking a detail-oriented Senior 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.
Job Responsibility:
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
Requirements:
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
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 have:
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
What we offer:
Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)
Daily on-site lunches provided from top eateries
A variety of perks on campus (state of the art gym, restaurant)
Free on-site EV charging (compatible with all EVs, including Tesla)