Senior CRA, Early Development - Remote

Parexel

Hartford (CT)

Remote

USD 90,000 - 140,000

Full time

4 days ago

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Job summary

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies in compliance with ICH GCP and local regulations. The role involves on-site and remote activities, data integrity, and collaboration with cross-functional teams to meet study deliverables.

Responsibilities include site qualification and monitoring visits, oversight of CRO activities, data review, and timely documentation.

Qualifications

Minimum 5 years of related experience as Sr CRA or equivalent.
Strong analytical and problem-solving skills.
Working knowledge of clinical drug development, ICH GCP, and regulatory requirements (FDA/EMA/PMDA).
Excellent written and verbal communication; proficient in IT tools (CTMS, EDC, MS Office).

Responsibilities

Perform site management to ensure protocol and regulatory compliance.
Conduct site qualification, initiation, interim, and close-out visits, on-site and remote.
Review site data and CSRs; ensure accurate data capture (ALCOA).
Prepare oversight monitoring plans and site performance reviews.
Write monitoring and oversight visit reports and regulatory documentation.
Identify deviations, escalate issues, and drive corrective actions.
Maintain site relationships and support inspection readiness.