Dr.Bitty R, Pharm D, Rph

Experience

• 

  Royal Care Super Speciality Hospital

  Dec 2021 - Mar 2022

  Clinical pharmacist intern

  Prescription auditing, Adr reporting, patient counseling, Dosage adjustment, Therapeutic Drug Monitoring, Solving queries

• 

  Believers Church Medical College Hospital

  Apr 2022 - Jul 2022

  Clinical Specialist

  Ward round participation under guidance of physician, Medication history interview, Drug information services, Electronic Record Monitoring, Identifying drug related problems

• 

  Maruthi Medical Center Hospital

  Aug 2022 - Dec 2022

  Clinical Pharmacist intern

  Case study and documentation of reports ,Patient counseling, literature review, Research and publications

• 

  Apollo Hospitals

  Mar 2023 - Apr 2023

  Clinical Research intern

  ICH-GCP , SOP , CRF ,ICF , Clinical trial, documentation,data management, Review Protocol, Ethical comittee coordinator

• 

  IQVIA

  May 2023 - now

  Centralized Monitoring Assistant

  Evaluate the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations.Manage the operational insight of the assigned projects, analyze and share the trends in the study/site metrics along with the plan of action and review the outcome of the suggested plan of action. Review, triage and action clinical study alerts and monitor compliance to Clinical Operation Plan With guidance, provide inputs to the clinical study teams, key decision makers and internal team members to manage continuous process improvements, issue escalation and workload projections. Maintained the project audit-ready by ensuring accurate and thorough documentation of all tools and templates used in the study. Managed triggers and prepared monitoring reports for sites and countries corresponding to the respective studies.Perform subject level data review that requires further investigation with the clinical site to determine overall accuracy of all the parameters from screening to the study discontinuation. Perform site level data review to identify the outstanding metrics data and follow up with the Clinical Research Associates for resolution.Assigned the discrepant/outstanding data as a task to the Clinical Research Associates via an internal portal and follow up until resolution. Presented Country Operations Lead and Clinical Research Associates with Central Monitoring insights of country-level metrics and site performances periodically for use in virtual investigator meetings.Conducted periodic reviews of site level Key Risk Indicators (KRI) and historic site performance as defined in the Central Monitoring Plan. Trained new Central Monitors on i-Medidata RAVE-EDC and mentored them on Central Monitoring activities.As a Subject Matter Expert (SME), offered guidance to Clinical Research Associates on Central monitoring activity reports generated for remote and onsite activities Show less