Veeresh Chakkadi Clinical Research Associate

Clinical Research Associate @Himalaya Wellness Company

Bengaluru, IN

Monitoring of clinical study to ensure that study is conducted in compliance with the protocol, Sponsors SOPs, Good Clinical Practice (GCP) and relevant regulatory guidelines Perform following monitoring activities directly or mange through SMO/ CRO-Perform Site Identification and conduct Feasibility Studies-Perform Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit-Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required-Training of Investigators/ sites on Protocol and other applicable regulatory guidelines including local regulatory guidelines-Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities- Coordinate for Ethics Committee Submission by sites-Ensure subject safety and adverse event reporting to sponsor and IRB/IEC- Verify drug accountability logs and storage requirements- CRF retrieval as per the project instructions Support the Clinical Project Manager in overall management of the assigned studies. Provide study status updates to team members and project management and facilitate project timelines Update clinical study trackers (including study update/ finance) Maintain accurate and timely sponsor/ CRO/ SMO /site correspondence and communication Primary point of contact for Clinical Operations aspects of designated study sites/ CRO/ SMO May be required to help in preparation of Regulatory Binder (Preparation and submission of clinical documents for International Regulatory Dossiers as per the country standard formats) Maintain updated Site Files and collection of the essential documents and project related documents and maintain Central Study File Coordinate and distribute Clinical Study Material to study sites. Coordination of Archival of study documents

Rajiv Ghandhi University of Health Sciences Karnataka

Master's degree