MARDAV SHAH

Associate - Clinical Research

Zydus Hospitals And Healthcare Research Pvt LTD

12.2020 - Current

Identifying potential participants for the trial, contacting them to explain the study, and assessing their eligibility to participate.
Explaining the study to participants and ensuring that they understand the risks and benefits before obtaining their written consent to participate.
Keeping track of participants' medical histories, administering questionnaires, collecting samples, and entering data into databases.
Ensuring that the trial is conducted in compliance with federal regulations and the study protocol, and reporting any adverse events or deviations to the principal investigator and sponsor.
Working closely with the principal investigator, other members of the research team, and sponsor or regulatory agencies to ensure that the trial is conducted safely and efficiently.
Keep track of the budget, expenses and financial tracking of the trial.
Communicating with participants, regulatory agencies, and other stakeholders to keep them informed of the progress of the trial.
Assists the PI in development of necessary materials to appropriately train individuals involved in the conduct of the study, like study protocol requirement, schedule of visits, execution of research plan.
Handle process management of site qualification visit, site selection visit, monitoring visit, and study close out.
Communication with ethics committee for getting approval for new study, amendment process and SAE discussion.
Record adverse event and side effects information and consult with investigators. Prepare a SAE report and notify the Ethics Committee. Sponsors & DCGI as per requirements.
Dispense study medication as protocol requirements and maintain accountability records.
Collect, Process, and Ship blood/urine specimens at scheduled patient visits.
Gather lab results or procedures reports and assure the investigator reviews them in timely manner.
Counseling study subjects and gives instructions as per study protocol, usage of drugs, Scheduled visits etc.
Completing paper CRFs and electronic CRFs.
Coordinate with sponsors/Doctors/Vendors/Internal departments to complete the research related activity.
Followed up regularly with the monitor, medical monitor for the resolution of queries.
Take telephonic follow up in timely manner as per protocol requirement.
Maintain a excel sheet, tracking updates to database of all subjects enrolled in clinical trials.
Prepared and processed all documentation for IRB submissions, notifications, and approval from IRB. Prepare a study progress report of all studies which are approved by IEC.
Attain investigator meetings for protocol training and report pertinent information back to research team members.
Participate in web Conference and teleconference for each study protocol in order to updated.