Experience

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  Narayana health

  Nov 2020 - now

  Overseeing the regulatory, sponsored, academic, grant and DNB proposal submitted to Ethics committee for approval as per the ICMR and New Drug Clinical Trial rules.To coordinate Ethics committee work (Medical ethics committee, Academic Ethics committee and Scientific Research Committee) with ethics committee members.To review protocols, consent forms, data collection forms and other documents required to conduct a study or a research trial.To conduct EC monitoring in the clinical trial sites to check trials are being done in compliance with theregulations and SOP.To conduct EC meetings.To conduct training programs for EC members as and when the new regulation come.To prepare SOPs for EC and renew them on a timely manner.To keep all registration (DCGI, NABH, DHR, FWA, IORG etc) in place and renew them in a timely manner.SUGAM portal (CDSCO), SAE report submission, and ethics committee registration and reregistration process.Help DNB to submit the protocol to EC in a timely manner.To coordinate with the Academic department for document submission or to resolve query from National Board Examination.To release the minutes in a timely manner for review to members.To implement the EC work from paper-based to electronic-based system.Proper documentation of the meeting documents, approvals. Show less • Maintain Source documents in the site for studies.• Create Templates for Source documentation.• Maintaining and updating Trial Master File.(TMF)• Participation in filling Feasibility forms.• Pre-screening to identify potential patients. Screening and Enrollment.• Assisting in patient recruitment and education.• Taking measures to prevent loss to follow-up and missed visits. Maintain drug accountability.• Ensuring proper storage, dispensation and accountability for clinical trial supplies at study site Forms (Both paper and electronic).• Adverse Event and Serious Adverse Event reporting within regulatory timelines.• Co-ordination with the Institutional Ethics Committee.• Responsible for Query handling and resolution.• Assisted in reviewing and creating SOPs for Site.• CRF filling (eCRF and Paper CRF) or EDC.• Adherence to the study Protocol and SOPs.• Ensuring every activity performed in compliance with ICH-GCP guidelines and Schedule-Y.• ICMR Guidelines/Indian GCP Show less

  • Clinical Research Coordinator ethics committee coordinator

    Sept 2021 - now

  • Regulatory Affairs Coordinator

    Sept 2021 - now

  • Clinical Research Coordinator

    Nov 2020 - Sept 2021