Senior Clinical Research Associate
ClinTec International
Total des années d'expérience :17 years, 1 Mois
Supervise and monitor clinical trials, ensure early identification and resolution of issues, timely completion and reporting of tasks and communication of important study findings. Review and help CRAs in addressing comments raised by Sites regarding clinical trial agreements, both in terms of legal aspects and financial ones and liaise with sponsor/ site as appropriate to achieve a mutually agreed outcome
Lead study start-up activities and assist in review and finalization of study and project-related documents. Act as liaison to CRAs and Project Manager (PM). Participate in client calls; provide updates on project; assist the client in problem solving and provide consultation on study related activities. Supervision of monitoring and remote data evaluation activities which may involve site visits
Ensure the resources of the Sponsor are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel. Prepare accurate and timely monitoring reports.
Have performed 20 Initiation visits, 30 close out visits & 200 plus Monitoring visits
Perform clinical trial initiation, monitoring and close out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs).
Assisting Investigators with all trial related works and also with responsibility for budget negotiation, monthly invoicing, account management, and regulatory paperwork.
Worked has a Study Monitor for Cardio Myopathy, Mitral Regurgitation -Device study
Implement the company policy successfully, develop strategic plans, maintain a dialogue between shareholders and sites, control finance, build and manage effective teams, and assume full accountability for all company operations
Assuring the quality of the final product& managing the team