Pranav Singh

Clinical Research Associate @Ethicare Clinical Trial Services Cro

Ahmedabad, IN

Being a CRA at Ethicare below is my work profile-1)Ensure compliance with standard protocol,regulatory and ICH-GCP obligations in assigned aspects of clinical site monitoring, such as feasibility, site initiation, routine monitoring, maintenance of study files, study close out procedures.2) Complete on-site and remote monitoring activities in compliance with the Clinical Monitoring Plan, including source document verification.3) Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.4) Assessing the suitability of potential clinical trial sites andidentifying an investigator to be responsible for the trial, briefing and training clinicians and site staff on clinical trial procedures and protocol.5) Setting up the clinical trial sites ensuring each center has thematerials needed to run the trial. Verifying proper management and accountability of Investigational Product at site.6) Manage essential documents as required by local regulations and ICH GCP before, during, and after a clinical study, assist with resolution of investigational site/data queries(EDC).7) Preparation of reports of investigational site findings and update applicable tracking systems as required escalate observed deficiencies and issues for resolution.8)Ensuring smooth conduct of close-out visit, archiving conditions at site/archival facility.Archival period as per regulatory guidelines. EC notifications required during close-out. Close-out visist report preparation and finalization.

Singhania University

Msc. Clinical Research

University of Mumbai

Bsc. Biotechnology