Global Clinical Research Associate - Monitoring & Compliance

Venesco, LLC; Washington (District of Columbia); On-site; USD 70,000 - 110,000; Full time

Job summary

Venesco LLC is seeking a Clinical Research Associate (CRA) to provide clinical monitoring and oversight to ensure studies comply with protocols, GCP, FDA regulations, ICH guidelines, and sponsor requirements.

The role conducts site qualification/ initiation/ monitoring/ closeout visits, performs SDV, reviews informed consent, documents deviations, maintains study files, and supports audits, CAPA, training, and communications across sites, with travel required CONUS and OCONUS.

Qualifications

• 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.

Skills

Communication skills

Travel ability

Education

Bachelor's degree in Life Sciences, Nursing, Public Health, or related discipline

Job description

Venesco LLC is seeking a Clinical Research Associate (CRA) to provide clinical monitoring and oversight to ensure studies comply with protocols, GCP, FDA regulations, ICH guidelines, and sponsor requirements.

The role conducts site qualification/ initiation/ monitoring/ closeout visits, performs SDV, reviews informed consent, documents deviations, maintains study files, and supports audits, CAPA, training, and communications across sites, with travel required CONUS and OCONUS.