Experience

AXELYS SANTE

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Research Associate

  • Nov 2020 - Present

  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.• Conduct and facilitate specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation, and all supporting site management activities to ensure timely site initiation• Perform all clinical monitoring tasks and/or remote visits, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines ensuring patient safety and data integrity at all times.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Manage and maintain the quality and regulatory compliance of Essential Documents and Investigator Site Files throughout the entire clinical study including CTMS and TMF maintenance.• Redaction of the SOPs.•Presentation of projects to the Scientific Committee; •Writing clinical study documents: synopsis, protocol, informed consent of the patient... •Prepare file for regulatory submission. Show less

• Clinical Research Associate

  • Feb 2020 - Present