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.
Job Tags
Contract work, Work at office, 3 days per week,