Senior CRA - Central/West US

Parexel International; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Parexel International is seeking a Senior Clinical Research Associate to manage investigator sites, monitor trial conduct, and drive quality from activation to close-out. You will maintain strong site relationships, ensure patient safety, and meet study milestones in a global, fast-paced environment.

Responsibilities include conducting on-site and remote monitoring, coordinating with the Site Care Partner, and ensuring regulatory and SOP compliance across trials.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Minimum 2 years monitoring experience in clinical research.
• Fluent in English and in the native language(s) of the country they will work in.

Responsibilities

• Ensure proper conduct of clinical trials in accordance with the SMP, laws, GCP, and sponsor standards to achieve goals.
• Manage operational aspects for site activation through database lock, ensuring timelines and quality.
• Serve as primary point of contact for investigator sites and coordinate with the SCP and study team.
• Interface with study team, vendors and sites to ensure smooth information flow.
• Perform investigator site development, coaching and training to ensure protocol compliance and patient safety.
• Attend investigator meetings and support site activation and recruitment initiatives.
• Conduct onsite, remote/electronic monitoring as required and ensure adherence to SOPs and SMP.
• Monitor site-level adverse events and collaborate with Drug Safety to resolve SAE reports.
• Submit required TMF documentation, site reports and other trial documentation on time.
• Identify and resolve site issues and implement corrective actions.
• Close-out site activities and ensure proper handling of investigational product.

Skills

Clinical trial methodologies

ICH/GCP

FDA regulations

English fluency

Travel readiness

Driver's license

Passport

Education

Bachelor’s degree in life sciences or related field

Job description

Parexel International is seeking a Senior Clinical Research Associate to manage investigator sites, monitor trial conduct, and drive quality from activation to close-out. You will maintain strong site relationships, ensure patient safety, and meet study milestones in a global, fast-paced environment.

Responsibilities include conducting on-site and remote monitoring, coordinating with the Site Care Partner, and ensuring regulatory and SOP compliance across trials.