Job Description

Job Description

Role: Senior Surgical Trial Clinical Research Associate (CRA III)

Location: Sunnyvale, CA | Onsite 3 days/week | ~40% travel

Schedule: In-house + Field Monitoring Support

Senior Clinical Research Associate – Surgical Trial Experience Required

Overview

The Senior Clinical Research Associate (Senior CRA) supports pre-market clinical studies for investigational drug trials within the Fluorescence Imaging program . This role operates independently and collaborates with Project Management and clinical teams to ensure regulatory compliance, study execution, and high-quality data . The position requires frequent travel for co-monitoring site visits with CRO monitors .

Key Responsibilities

• Lead and support site start-up, activation, and ongoing study management from initiation through FDA submission .
• Conduct and assist with site qualification, training, recruitment , and study progress oversight .
• Co-manage study documentation including protocols, ICFs, eCRFs/EDC, CTMS, eTMF , and monitoring plans .
• Perform on-site and remote monitoring visits (SQV, SIV, IMV, COV), ensuring source data verification and drug accountability .
• Partner with CRO to manage data cleaning, query resolution , and tracking of enrollment, AEs/SAEs , and study reports .
• Support IRB submissions, study amendments, audit readiness , investigator meetings , and study presentations .

Required Experience

• 8+ years of clinical research experience , or equivalent advanced degree (Nursing, MS, MD, PhD).
• Surgical trial experience is required.
• Strong background in pharmaceutical clinical trials , preferably within hospital or surgical settings .
• Deep understanding of ICH/GCP , FDA regulations , and investigational drug studies .
• Experience with clinical budgets and contract negotiations .
• Proficiency with EDC, CTMS, eTMF , and Microsoft Office Suite .
• Excellent communication, organization, and cross-functional collaboration skills.

Preferred

• Hands-on experience in hospital/surgical environments working closely with physicians and surgeons .
• Knowledge of statistics or study design methodology a plus.

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