Clinical Research Associate
About this role
Description
Clinical Research Associate
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
Duties and 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.
Minimum 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.
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.
Company at a glance
Venesco, LLC is a premier government contractor delivering Healthcare, IT, Research & Development, and a range of mission‑critical services to federal agencies. For more than 18 years, we’ve evolved from a small consulting firm into a respected leader in biomedical R&D and IT support, backed by strong financials, mature processes, and a commitment to employee connectedness and work–life balance.
Our success is driven by our skilled professionals, agile management practices, and high‑quality standards. Venesco holds a Top‑Secret Facility Clearance and maintains CMMI® Maturity Level 3 (Services) and ISO 9001:2015 and 14001:2015 certifications. We’ve been recognized on the Inc. 5000 and Washington Technology’s Fast 50 lists for five consecutive years.
With more than 350 credentialed employees and 65+ prime contracts — ranging from small teams to programs with 150+ personnel — we deliver the impact of a large enterprise while maintaining the agility of a small business. Venesco continues to recruit motivated, talented individuals who want to contribute to meaningful federal initiatives and join a collaborative, high‑performing team.
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