Senior Clinical Research Associate – Pool

This is a fully remote position, open to applicants in California.

📋 Description

• Primarily accountable for overseeing clinical sites and monitoring clinical data at designated locations.

• Independently carry out monitoring duties for clinical trials across Phases 1, 2, and 3.

• Prepares for and performs site qualification, site initiation, interim, and closeout monitoring visits.

• Serves as the primary liaison between assigned sites and the Sponsor.

• Conducts all monitoring activities with a keen emphasis on data integrity and patient safety, complying with GCP protocols and Sponsor requirements.

• Produces high-quality and timely reports following each monitoring visit.

• Completes and submits monitoring-related expense reports in line with the company's and/or Client’s travel & expense policies.

• Collaborates with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites.

• Maintains the Trial Master File (TMF)/Electronic Trial Master File (eTMF) for the designated sites.

⛳️ Requirements

• A minimum of 5 years of independent clinical monitoring experience is preferred.

• Exceptional written and verbal communication abilities, including strong presentation skills for both internal and external audiences.

• Comprehensive knowledge and understanding of ICH/GCPs and relevant regulatory requirements.

• Proficient computer skills, including a working knowledge of Microsoft Office applications (Word, Excel, Outlook, etc.).

• Familiarity with current GCPs/ICH/FDA regulations and guidelines to evaluate compliance with applicable standards.

🏝️ Benefits

• Health insurance

• 401k retirement plan

• Paid days off

• Annual performance bonus