Senior Clinical Research Associate

November 27

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Contributes to the selection of potential investigators. • The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct. • Ensures sites are inspection ready. • Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. • Shares information on patient recruitment and study site progress. • Manages study supplies and drug accountability at study sites. • Performs monitoring visits (remote and onsite). • Prepares and finalizes monitoring visit reports in CTMS. • Ensures compliance with local, national, and regional legislation. • Supports/participates in regular QC checks.

Requirements

• Experience in monitoring hematology trials is required. • Excellent attention to detail. • Good written and verbal communication skills. • Good collaboration and interpersonal skills. • Good negotiation skills. • Proficient in written and spoken English. • Fluency in local language(s). • Ability to work with remote collaborators. • Good analytical and problem-solving skills. • Ability to understand the impact of technology on projects. • Good knowledge of international guidelines ICH-GCP. • Familiar with risk-based monitoring approach including remote monitoring. • Basic understanding of the drug development process. • Excellent knowledge of International guidelines ICH-GCP.