Job Description
Title: Senior Clinical Research Associate (In-House in Sunnyvale & Field Role); Job Posting Title: Clinical Research Associate 3; Location: Sunnyvale, CA (Onsite 3 days per week); Travel: Up to 40%; Pay Rate: $58.00/hr.
Primary Function: The Senior Clinical Research Associate supports pre‑market clinical studies of investigational drugs within the Fluorescence Imaging group, ensuring compliance with ICH/GCP and US regulations for human subjects. Works independently with minimal supervision, collaborating with Senior Clinical Project Managers, the Head of Fluorescence Imaging Clinical Team, and cross‑functional stakeholders. Frequent travel to investigational sites to conduct co‑monitoring with CRO‑assigned field CRAs/monitors.
Essential Duties: Contribute to all clinical research activities to enable successful study start‑up through FDA approval. Maintain and track clinical study data; support investigator and sub‑investigator qualification/selection, training, patient recruitment assessment, and overall study status/progress. Co‑manage site start‑up/activation, prepare study documents and checklists, support clinical trial agreements and budget negotiations, finalize clinical monitoring plans and training materials. Assist with eCRFs/EDC systems, CTMS, eTMF, and imaging Core Labs. Review IRB submissions, consents, and regulatory documentation, ensuring successful outcomes. Support amendments to study documents (ICF, CRFs, protocols, monitoring plan, study tools) and assist sites with IRB submissions as needed. Perform on‑site and/or remote qualification, initiation, interim co‑monitoring, and close‑out visits (with or without CRO). Conduct co‑monitoring to ensure protocol/regulatory compliance and data accuracy per the monitoring plan. Complete source data verification of data entered in EDC or on CRFs. Support sites for timely data entry, data integrity, query resolution, investigational drug accountability, and study oversight. Partner with CRO data management on data cleaning. Develop/manage the eTMF and maintain study documentation and CTMS (correspondence, CRFs, approvals), trip reports, site contact documentation, and monthly status reports (enrollment, adverse events, budget). Assist Sr Clinical Project Manager with study scoping (pre‑study questionnaires, study design, surgeon/site selection). Prepare sites for audits and inspections and support during audits (site, internal, external). Prepare and present for SIVs and investigator meetings, including logistics and planning.
Required Skills/Experience: Prior experience implementing pharmaceutical clinical trials; significant knowledge of clinical/outcomes research study design; surgical trial experience preferred. Advanced knowledge of clinical investigation of investigational drugs for human subjects. Strong understanding of ICH/GCP and applicable regulations; fundamental knowledge of clinical research and monitoring requirements. Experience with protocol and ICF development and amendments; negotiating clinical research contracts and budgets. Strong cross‑functional collaboration and excellent communication/presentation skills; ability to manage multiple priorities with high attention to detail and organization; self‑starter with problem‑solving mindset. Proficiency with Microsoft Office Suite and PDF applications. Experience with EDC systems required; experience with CTMS and eTMF. Ability to travel up to 40%.
Education/Training: Typically requires a minimum of 8 years of related experience with a BA/BS; or a minimum of 6 years with a Nursing degree; or a Master’s, MD, or PhD with a minimum of 5 years of clinical research experience. Clinical research/clinical trial management certification/education preferred.
Preferred: Knowledge of statistics, statistical methods, and design of experiments. Accustomed to hospital environments; experience working with nurses and surgeons preferred.
Work Arrangement: Hybrid (onsite in Sunnyvale, CA three days per week) with frequent site travel for co‑monitoring.