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.