Senior CRA: Site Monitoring & Trial Leadership

Parexel; Phoenix (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate to oversee site management, monitoring, and close-out of investigator sites to ensure patient safety and high-quality study execution per GCP and sponsor standards.

You will collaborate with the SCP and study team, train site personnel, and monitor progress, timelines, and data quality across complex oncology trials. Travel will be substantial to active sites in the region.

Qualifications

• Monitoring experience in clinical research site monitoring (minimum 3 years, preferably in Oncology)
• Extensive knowledge of ICH/GCP, FDA regulations, and local country requirements
• Global clinical trial experience preferred
• Fluent in English and local language(s) as required
• Travel (60-80%) within area is required
• Valid driver’s license and passport required

Responsibilities

• Ensure proper conduct of clinical trials in accordance with SMP, laws, GCP and sponsor standards to meet goals
• Manage operational aspects from site activation through to database lock with quality deliverables
• Act as primary contact for assigned investigator sites and coordinate with SCP
• Facilitate information flow between study team, vendors and sites
• Provide investigator site development and protocol training to site staff
• Attend investigator meetings and support enrollment/recruitment at the site level
• Conduct onsite, remote/electronic monitoring per SMP and SOPs
• Monitor site-level AEs/SAEs and coordinate with Drug Safety to resolve
• Submit TMF documentation, site reports, deviations, and progress updates
• Identify and resolve site issues with corrective actions to prevent recurrence
• Close-out plans and data queries resolution; ensure product oversight at sites
• Support database release as needed
• Possibly undertake unblinded monitoring when appropriate
• Provide risk-based insights and maintain sponsor credibility with investigators
• Mentor junior CRAs when required

Skills

Monitoring experience

Oncology experience

Global clinical trials

ICH/GCP knowledge

Fluent English

Travel 60-80%

Driver’s license & passport

Education

Bachelor’s degree in life sciences

Job description

Parexel is seeking a Senior Clinical Research Associate to oversee site management, monitoring, and close-out of investigator sites to ensure patient safety and high-quality study execution per GCP and sponsor standards.

You will collaborate with the SCP and study team, train site personnel, and monitor progress, timelines, and data quality across complex oncology trials. Travel will be substantial to active sites in the region.