Senior CRA: Global Site Monitoring & Protocol Support

Parexel; Richmond (VA); Sur place; USD 70 000 - 95 000; Plein temps

Résumé du poste

Parexel is seeking a Clinical Research Associate to manage investigator sites, monitor study conduct, and oversee site close-out to ensure patient safety and high-quality data in line with GCP and sponsor standards.

The CRA will travel 60–80% to sites, require a life sciences degree, fluent English and local language, and hold a valid driver’s license and passport. This full‑time role involves collaboration with the SCP and study team to support enrollment, data release and QA.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations.
• Monitoring Experience: Minimum 2 years in clinical research site monitoring.
• Fluent in English and in the local language of the country they will work in.
• Ability to travel 60-80%.
• Valid driver’s license and passport required.

Responsabilités

• Ensure proper conduct of clinical trials per SMP, laws, GCP and sponsor standards.
• Manage site activation through database lock with timelines and quality.
• Serve as primary contact for investigator sites; coordinate with SCP and study team.
• Interface with study team, vendors, and sites to ensure information flow.
• Coach and train site personnel to maintain protocol compliance and patient safety.
• Attend investigator meetings and support enrollment initiatives at sites.
• Conduct on-site and remote monitoring consistent with SMP and SOPs.
• Monitor and follow up on AEs/SAEs with Drug Safety and site teams.
• Submit TMF, site reports and protocol deviations within required timeframes.

Connaissances

Clinical trial knowledge

GCP/regs (ICH/FDA)

English & local language

Travel readiness

Driver’s license & passport

Formation

Bachelor’s degree in life sciences

Description du poste

Parexel is seeking a Clinical Research Associate to manage investigator sites, monitor study conduct, and oversee site close-out to ensure patient safety and high-quality data in line with GCP and sponsor standards.

The CRA will travel 60–80% to sites, require a life sciences degree, fluent English and local language, and hold a valid driver’s license and passport. This full‑time role involves collaboration with the SCP and study team to support enrollment, data release and QA.