Senior CRA: Phase I Monitoring & Site Oversight

Parexel; Olympia (WA); On-site; USD 90,000 - 125,000; Full time

Job summary

Parexel is seeking a SrCRA to support monitoring and site management for client-sponsored studies. You will conduct on-site and remote visits, ensure adherence to ICH GCP and local regulatory requirements, and collaborate with cross-functional clinical trial teams to meet study deliverables.

The role emphasizes oversight of investigator sites, review of source documentation for ALCOA compliance, timely reporting, and ongoing inspection readiness to sustain data integrity across studies.

Qualifications

• Bachelor's degree required.
• Minimum of 5 years of CRA or Sr CRA experience.
• Strong knowledge of ICH GCP and global regulatory requirements (FDA/EMA/PMDA).

Responsibilities

• Perform site management and monitoring activities per protocol and SOPs.
• Conduct site qualification, initiation, interim, and close-out visits on-site or remotely.
• Collaborate with CTL and other client functions to support site activation and deliverables.
• Review site source documentation and ensure accurate data capture (ALCOA).
• Prepare and submit monitoring and oversight visit reports in a timely manner.
• Support inspection readiness and ensure data integrity at investigator sites.

Skills

Effective communication

Interpersonal skills

Analytical problem-solving

Time management

Regulatory knowledge (FDA/EMA/PMDA)

Clinical trial operations

Education

Bachelor's degree (or equivalent)

Tools

CTMS

EDC

Data repositories

Job description

Parexel is seeking a SrCRA to support monitoring and site management for client-sponsored studies. You will conduct on-site and remote visits, ensure adherence to ICH GCP and local regulatory requirements, and collaborate with cross-functional clinical trial teams to meet study deliverables.

The role emphasizes oversight of investigator sites, review of source documentation for ALCOA compliance, timely reporting, and ongoing inspection readiness to sustain data integrity across studies.