Santoshi Rathod

Assist including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents. Review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines. Other activities as: Manage clinical systems, Manage study documents and support eTMF management, Support study teams to resolve data management queries, Maintain study databases (CTMS, IWRS, EDC etc. Track and follow up with CRAs for outstanding issues

Associate TMF Specialist duties in accordance with the company guidelines and work instructions (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.) Ensures that all new and updated record information is accurately entered in the appropriate records management databases, such eTMF Veeva Vault, for inspection readiness and highest quality of document governance. Monitors and identifies TMF trends and escalates concerns to management.

-Coordinate activities with the site and internal departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provide training on completion of the eCRF and EDC system; monitoring activities and study close-out activities. - Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory.

Proactively worked with large, multidisciplinary teams like principal Investigator to help ensure that clinical research and related activities are performed in rules, regulations, and procedures as a “Clinical Research Coordinator”. - Reviews and develops a familiarity with the protocol, e.g. study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Work with PI to manage the day to day activities of the solving, communication, and protocol amendment.