Job Description
Senior Clinical Research Associate (In-House in Sunnyvale & Field Role) supporting pre‑market clinical studies of investigational drugs for the Fluorescence Imaging group at Intuitive Surgical. This team operates like a startup within a larger organization and is focused on pharmaceutical clinical trials, not device monitoring. The role supports two Phase 3 programs (prostate cancer and ureter identification) and requires frequent collaboration with surgeons and cross-functional stakeholders. Work location is Sunnyvale, CA (onsite 3 days per week) with up to 40% travel for co‑monitoring at investigational sites across TX, NV, FL, CA, OH, and CT.
Primary responsibilities include: contributing to all clinical research activities from study start‑up through FDA approval; tracking study progress and data; co‑managing site start‑up/activation, preparing study documents and checklists; assisting with clinical trial agreements and budget negotiation; supporting development and maintenance of monitoring plans and training materials; assisting with EDC/eCRFs, CTMS, eTMF, and imaging core lab interfaces; reviewing IRB submissions, consents, and regulatory documentation; drafting and amending study documents (ICF, CRFs, protocols, monitoring plans, study tools); conducting on‑site and remote qualification, initiation, interim co‑monitoring, and close‑out visits; performing source data verification; ensuring data integrity, timely entry, query resolution, and investigational drug accountability; partnering with CRO data management on data cleaning; managing eTMF and study documentation, trip reports, site contact documentation, and status reports; supporting study scoping (pre‑study questionnaires, study design, surgeon/site selection); preparing for and supporting site and internal/external audits; preparing and presenting SIVs and investigator meetings.
Required qualifications: previous hands‑on pharmaceutical drug trial implementation; significant knowledge of clinical/outcomes research study design; advanced knowledge of clinical investigation of investigational drugs; strong working knowledge of GCP/ICH‑GCP and FDA expectations; experience with protocol and ICF development and amendments; experience negotiating clinical research contracts and budgets; proficiency with EDC, CTMS, eTMF; excellent interpersonal and communication skills; ability to work cross‑functionally and manage multiple priorities; ability to travel up to 40%; high attention to detail, organization, and a self‑starter attitude. Experience with surgical trials is preferred; fluorescence imaging experience is a strong plus. Proficiency with Microsoft Office and PDF applications is required.
Education/experience: typically 8+ years of related clinical research experience with a BA/BS; or 6+ years with a Nursing degree or a Master’s; or 5+ years with an MD/PhD. Preferred: knowledge of statistics, statistical methods, and design of experiments; accustomed to hospital environments and working with nurses and surgeons.
Additional details: Pay rate $92/hr W2. Onsite 3 days per week in Sunnyvale, CA with approximately 40% travel. Estimated project duration 6 months. Interview process includes three Zoom rounds and an onsite interview. Business Unit: Clinical Public Affairs Function. Site: 1020 Kifer Rd, Bldg 108.