Senior CRA – Phase I Monitoring & Oversight

Parexel; Annapolis (MD); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate to support monitoring and site management for client-sponsored studies, following ICH GCP and local regulations. This role involves on-site and remote activities with documentation in CTMS.

You will collaborate with cross-functional teams, perform visits, conduct drug accountability, and oversee investigator sites to meet study deliverables. A Bachelor's degree and 5+ years of CRA experience are required.

Qualifications

• Bachelor's degree or equivalent required.
• Minimum of 5 years of related experience for Sr CRA.
• Strong knowledge of ICH GCP, FDA/EMA regulations and clinical drug development processes.

Responsibilities

• Perform site management activities to ensure protocol and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits on-site and remotely.
• Prepare and submit monitoring visit reports and study correspondence in a timely manner.
• Review site source data for accuracy and ALCOA compliance.
• Escalate issues and ensure follow-up with relevant teams.

Skills

Communication

Analytical thinking

Problem solving

Documentation

Time management

Education

Bachelor's degree or equivalent

Tools

CTMS

EDC

Data repositories

Microsoft Office

Job description

Parexel is seeking a Senior Clinical Research Associate to support monitoring and site management for client-sponsored studies, following ICH GCP and local regulations. This role involves on-site and remote activities with documentation in CTMS.

You will collaborate with cross-functional teams, perform visits, conduct drug accountability, and oversee investigator sites to meet study deliverables. A Bachelor's degree and 5+ years of CRA experience are required.