Evolution Research Group

Clinical Research

• Independently manage and monitor site activities for assigned clinical studies
• Conduct site qualification, site initiation, interim monitoring, and close-out visits
• Perform site evaluation visits and assess investigator-site capability
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Maintain audit-ready Investigator Site Files and ensure timely document upload to the Trial Master File
• Communicate directly with investigational sites regarding visit planning, query resolution, action items, and site management
• Document clinical-trial-material accountability, stability, and storage conditions
• Perform investigational product inventory and coordinate return or destruction of unused materials
• Serve as primary site contact and coordinate correspondence and timely clinical-data transmission
• Perform study close-out visits, investigational-product reconciliation, site-file reconciliation, query resolution through database lock, and outstanding-action resolution
• Complete internal and study-related training within required timelines
• Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
• Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable
• Follow safety practices while traveling and visiting clinical research sites

Senior Clinical Research Associate – CRO Contract

• Independently manage and monitor site activities for assigned clinical studies
• Conduct site qualification, site initiation, interim monitoring, and close-out visits
• Ensure compliance with protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines
• Perform site evaluation visits and assess investigators’ site capabilities
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Ensure Investigator Site Files remain audit-ready and documents are uploaded to the Trial Master File
• Communicate with investigational sites regarding visit planning, query resolution, action items, and site management
• Document clinical trial material accountability, stability, and storage conditions; perform investigational product inventory
• Coordinate site correspondence and ensure timely transmission of clinical data
• Perform close-out visits, investigational product reconciliation and disposition, study file reconciliation, query resolution through database lock, and outstanding action-item resolution
• Complete internal and study-related training within required timelines
• Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
• Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable

Senior Clinical Research Associate – CRO Contract

Senior Clinical Research Associate – CRO-Contract