Senior Clinical Research Associate – Pool

• Primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites.
• Independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3.
• Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits.
• Main point of contact between assigned sites and Sponsor.
• Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements.
• Delivers high quality and timely reports following each monitoring visit.
• Completes and submits monitoring‑related expense reports in accordance with the company and/or Client’s travel & expense guidelines.
• Works with the Clinical Operations Manager to identify, elevate, and resolve issues at assigned clinical sites.
• Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites.

Requirements

• 5+ years of independent clinical monitoring experience preferred
• Excellent written and verbal communication skills including strong professional presentation skills (internal and external audiences)
• Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements
• Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.)
• Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines.