Experience

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  Sumandeep vidyapeeth, vadodara

  Aug 2021 - Jul 2022

  Clinical pharmacist

   Posted in various department like General medicine, Respiratory medicine, ICU, ICCU, Paediatric, Neurology, Psychiatry, Dermatology, Oncology. Part of clinical team during ward rounds, drug therapy review discussions during ward rounds, prescription audit, patient monitoring, medication adherence, drug-drug interactions, ADR identification & reporting, dose calculation, provide drug information, patient counselling, Case presentations on various diseases and its guidelines. Conducted teaching & training sessions for juniors on topics like clinical research, role of clinical pharmacist, dose calculation, various diseases & their treatments. Handled medical camps for rural areas as primary healthcare activity organized by the Sumandeep Vidyapeeth, Gujarat.  Completed project work on the following study title: An observational, prospective cross-sectional study to assess the impact of frailty and its correlation with comorbidity, cognition & quality of life in patients undergoing haemodialysis. Show less

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  Avenida innovations

  Nov 2021 - now

  Avenida ambassador

  Reaching every Pharm. D students across India to help them grow with correct guidance from right people.

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  Meril

  Sept 2022 - Dec 2022

  Clinical trial assistant

  Coordinate with various stake holders to expedite & track the progress of clinical trials including subject recruitment, clinical supplies & trial documentations. Ensure GCP & protocol compliance during the conduct of study & minimizing protocol deviations.  Coordinate for EC submissions by preparing site specific dossier. Maintain & update various tracker & electronic Trial Master File (eTMF). CTA drafting, finalization & execution. Clinical Trial Registry of India (CTRI) registration. Protocol, EDC and other training activities for internal & Site team. Site Feasibility visit & Interim Monitoring Visit as a co-monitor, discussion with PI regarding study specific concerns & suggestions. Show less

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  Cbcc global research

  Dec 2022 - now

  Junior clinical research associate

  1. Experience of executing clinical trials from start-up to closeout in various therapeutic areas..2. Responsible for site identification, study proposal to PIs/Site Managers, feasibility assessment, shortlisting sites for qualification visits, and finalizing essential documents3. Prepare regulatory submission dossiers, coordinate EC submissions, and track DCGI & EC approvals.4. Participate in project budget and timeline discussions, prepare site-specific study budgets, and negotiate budget with sites.5. Proficient with EDC platforms (Clinion, SyMetric) and CTMS platform (REVVA).6. Perform User Acceptance Testing (UAT) of EDC.7. Responsible for TMF review and compilation.8. Maintainstudy-specific trackers.9. Handle shipments and management of IP & PK samples.10. Review and process invoices from sites, vendors, and stakeholders.11. Ensure adequate availability of supplies on sites as per study schedules.12. Conduct EDC data review and cleaning, compile and finalize protocol deviations as per CDISC requirements.13. Complete archival activities.14. Reconcile finance and expenses of the study against budgeted amounts and timelines.15. Review CSR and address stakeholder comments.16. Ensure compliance with quality management system standards.17. Provide insights in strategic planning for risk mitigation and early subject recruitment.18. Train and orient new joiners on company processes and trial-specific activities19. Resolve audit observations, and assist in site inspection readiness.20. Accompany CRAs as co-monitor on SIV, SMV & SCV.21. Conduct on-site training of protocol, EDC, IWRS, GCP to site teams, engage KOLs, and address investigator queries22. Review ISF, signed ICF, Source documents, and IP management during monitoring visits. 23. Ensure complete and accurate documentation of ISF, patient files, retention/destruction of IPs, IP accountability & reconciliation, and archival during closeout visits. Show less