Senior CRA - Phase I Trials & Site Monitoring Leader

Parexel; Phoenix (AZ); On-site; USD 85,000 - 125,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. The role spans on-site and remote activities with CTMS-based documentation, ensuring adherence to ICH GCP and regulatory requirements.

Responsibilities include site qualification/initiation/visits, oversight monitoring, data verification (ALCOA), and timely reporting. Strong communication, problem-solving, and collaboration with cross-functional teams are

Qualifications

• Bachelor's degree (or equivalent).
• Minimum of 5 years of related experience for Snr CRA.
• Strong analytical problem-solving skills and critical thinking abilities.
• Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (FDA, EMA, PMDA).

Responsibilities

• Perform site management and monitoring activities to ensure protocol and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits (on-site and remote).
• Collaborate with CTL and other client functions to support site activation and deliverables.
• Maintain productive relationships with investigator site staff and communicate effectively.
• Review site source documentation for data accuracy and ALCOA compliance.
• Prepare and submit monitoring visit reports and oversight monitoring visit reports.
• Ensure site regulatory files are current and timely with safety reporting.
• Identify and escalate protocol deviations and issues to appropriate teams.
• Engage in team meetings and process improvement initiatives.
• Support inspection readiness activities and maintain data integrity.

Skills

Effective communication

Interpersonal skills

Medical terminology

IT applications (Microsoft Office, EDC

Education

Bachelor's degree

Tools

Microsoft Office

EDC

CTMS

Data repositories

Job description

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. The role spans on-site and remote activities with CTMS-based documentation, ensuring adherence to ICH GCP and regulatory requirements.

Responsibilities include site qualification/initiation/visits, oversight monitoring, data verification (ALCOA), and timely reporting. Strong communication, problem-solving, and collaboration with cross-functional teams are