Clinical Research Associate

VENESCO, LLC • Fort Detrick, MD

19d • $100,000 - $110,000 • Onsite

About The Position

Venesco LLC is seeking a Clinical Research Associate (CRA) to provide clinical monitoring and oversight support to ensure studies are conducted in compliance with protocols, Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and sponsor requirements.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Public Health, or related discipline.
• Minimum 3 years of clinical monitoring experience.
• Knowledge of FDA regulations, ICH-GCP, and clinical research practices.
• Strong written and verbal communication skills.
• Ability to travel CONUS and OCONUS.

Responsibilities

• Conduct site qualification, initiation, monitoring, and closeout visits.
• Perform source data verification (SDV).
• Review informed consent documentation and study records.
• Evaluate protocol compliance and identify deviations.
• Review regulatory binders and essential documents.
• Generate clinical monitoring reports and follow-up letters.
• Support site training and communication activities.
• Track and assist with CAPA implementation.
• Support audit and inspection readiness.
• Maintain study documentation and monitoring files.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level