Ajay R. Yadav
Clinical Research Associate @Meril
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WORK HISTORY
Clinical Research Associate @Meril
Vapi, IN
Participate in the investigator recruitment process. Perform initial qualification visits of potential investigators and sites. Evaluate the capability of the site to successfully manage and conduct the clinical study, both clinically and technically. Work with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Work with Study Start-up Group and site study team to obtain regulatory (IRB/IEC) approval of study specific documents. Perform study initiation activities, reviewing with the site study team the protocol, regulatory issues, study procedures, and provide training on completion of the eCRF; monitoring activities and study close-out activities. Train site study team on the EDC system. Conduct periodic site file audits to ensure compliance with GCPs and sponsor’s standard operating procedures. Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Perform validation of source documentation as required by sponsor. Prepare monitoring reports and letters in a timely manner. Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries. Review protocols, eCRFs, ICF and other related documents, as requested by Project Manager. Serve as primary contact between sponsor and investigator; coordinate all correspondence; ensure timely transmission of clinical data with the study site and technical reporting, as required. Assist with final date review and query resolution through database lock
EDUCATION
NES Ratnam College
Bachelor of Science (B.Sc.)
Institute of Clinical Research India (Mumbai)
Master of Science (M.Sc.)
SKILLS
ABOUT AJAY R. YADAV
A Clinical Research Professional with an extensive clinical project experience of more than 7 years from concept to development in Medical Device domain. Enriched experience in the conduct of clinical trials of Structural Heart, Transcatheter Aortic Valve Replacement (TAVR), Coronary Stents and Scaffold, Peripheral Stents and Scaffold, Surgical Bioprosthetic Heart Valves, Mechanical Heart Valves, Endo-surgical devices and COVID 19 diagnostic kits. Talents include in-depth knowledge of cardiovascular therapeutic area, ICH GCP guidelines, Medical Device Regulations, MDR 2017/745/EU, GDPR, ISO 14155. Masters in Clinical research with background of Zoology & Chemistry in Bachelors. Experienced in Study Start up and Study Conduct activities in Europe, Asia, South Africa and monitoring multiple site locations in India and remote monitoring globally, clinical site evaluation, initiation & maintenance in accordance with GCP & SOP while ensuring integrity of study data & following study timelines. Collaborative team player & acting as key resource to colleagues & allied healthcare professionals.
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