Research Analyst

• Conduct site monitoring responsibilities for clinical trials
• Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality
• Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed
• Ensure appropriate and timely investigator site visits
• Coordinate with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
• Assist in development of study-specific Monitoring Plans and training presentations as required
• Manage study budget and act as referent for the sponsor
• Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
• Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests
• Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs
• Conduct audit preparation at study sites as needed

Senior Clinical Research Associate

Senior Clinical Research Associate

Freelance Market Research Analyst – Financial Services