Senior CRA: Remote Site Lead for Clinical Trials

Parexel; Salem (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

Parexel FSP in the US seeks a Senior Clinical Research Associate (Sr. CRA) to manage site monitoring, activation through close-out, and ensure patient safety and data integrity across trials. You will work with the SCP and study team to resolve protocol-related issues and enhance site performance.

The Sr. CRA will monitor sites, coordinate with investigators, provide site training, and support enrollment initiatives while adhering to ICH/GCP, SOPs, and client standards.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Global clinical trial experience
• Must be fluent in English and in the native language(s) of the country they will work in
• Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
• Valid driver’s license and passport required

Responsibilities

• Oversee monitoring responsibilities and study conduct to meet project goals, timelines and quality.
• Manage operational aspects for site activation through database lock with quality deliverables.
• Serve as primary contact for investigator sites and coordinate with SCP for site delivery quality.
• Interface with study team, vendors, and investigator sites to ensure smooth information flow.
• Provide investigator site development, coaching and training to ensure protocol compliance and patient safety.
• Attend investigator meetings and support enrollment and recruitment initiatives at site level.
• Conduct onsite, remote/electronic monitoring per SMP and SOPs.
• Monitor AEs/SAEs and follow up with investigators to resolve issues.
• Submit required reports and TMF documentation within required timeframes.
• Identify and resolve investigator site issues with corrective/preventive actions.
• Close-out activities and product oversight at sites; support database release as needed.

Skills

Clinical trial knowledge

Monitoring experience

Oncology experience

Global trials

English fluency

Education

Bachelor's degree in life sciences

Job description

Parexel FSP in the US seeks a Senior Clinical Research Associate (Sr. CRA) to manage site monitoring, activation through close-out, and ensure patient safety and data integrity across trials. You will work with the SCP and study team to resolve protocol-related issues and enhance site performance.

The Sr. CRA will monitor sites, coordinate with investigators, provide site training, and support enrollment initiatives while adhering to ICH/GCP, SOPs, and client standards.