Hema Dave

• Coordinates all aspects of the clinical monitoring and site management process by ICH GCP, FDA guidelines, local regulations, and client SOPs • Prepares detailed site data for site visits in collaboration with CRAs and assists with site pack preparation • Oversees Vendor query management, site performance, and clinical data management • Documents site observations promptly, escalating deficiencies and proposing solutions to clinical management • Participates in weekly site follow-ups, CRA follow-ups, and project leadership calls • Maintains study trackers, and query trackers, and updates client systems with accurate data • Provides trial status tracking and progress update reports to Clinical Lead • Manages essential documents as required by local regulations • Trained new employees within the department. • Worked with software like CTMS, CM Platform, ELVIS, eTMF.

•Conduct site-level feasibility evaluation for specific projects •Utilize an in-house database to shortlist plausible sites for feasibility assessment •Collect documents (IU/PSP/CV/FDA 1572 etc) for regulatory submissions from sites •Gather vital documents for EC submission from sites, and dispatch the dossier. •Prepare and dispatch DCGI Dossier to the DCGI liaison person for submission in session with CRA/PM or assist the PM with the online DCGI application •Track EC and DCGI submission and approval progress •Coordinate the supply of project-specific clinical trial substances to sites, including ISF, PK kits, central lab kits, etc. •Develop training material and train site personnel, local study team, research monitors, etc., on study-specific clinical supply and documentation matters •Prepare site files, eTMF files, TMF files, trial-related trackers, and draft communications •Track and report on study start-up activities to PM •Input and review payment terms and fee schedule of the Clinical Study Agreement. •Develop training material and train site personnel, local study team, research monitors, etc., on study-specific clinical supply and documentation matters •Handle import shipping approval and responsible for the notification, and investigation of product quality complaints. •Supported CRA in Conducting the Site initiation visit remotely for Unites States sites.

•Overseeing the smooth running of clinical trials from recruitment of study participants, data collection; management of study databases; execution of study-related administrative tasks •Collecting, coding, and analyzing data obtained from research. •Managing research budgets. •Informing participants about study objectives and coordinating with visit schedules. •Administering questionnaires. •Monitoring research participants to ensure adherence to study rules. •Adhering to research regulatory standards. •Adhering to ethical standards. •Maintaining detailed records of studies as per FDA guidelines, including things such as drug dispensation. •Liaising with laboratories regarding findings. •Participating in subject recruitment efforts. •Ensuring that the necessary supplies and equipment for a study are in stock and working order. •Engaging with subjects and understanding their concerns. •Actively participating/coordinating in Institutional ethics committee meetings and related work. •Data entry for Several internal projects.