Jyoti Sharma

Experience

• 

  Advanced Centre for Treatment, Research and Education in Cancer(ACTREC)

  Jun 2015 - Jan 2018

  Junior Research ScientistResponsibilities:*Submitting regulatory documents to IRB and Sponsor*Attending investigator meeting(s)*Preparing for study initiation*Recruiting, screening and scheduling subjects*Getting voluntary subject consent*Teaching subjects about protocol expectations for them*Performing study/protocol procedures in a detailed, accurate manner*Maintaining and archiving study documentation and correspondence including the trial drug often known as the investigational medicinal product;*Tracking and maintaining the study budget and payments, including invoicing the sponsor for completed work*Tracking subjects, avoiding lost-to-follow-up*Documenting an adverse event, including: -describing the event -severity and frequency -treatment -resolution*Processing and shipping lab work*Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel, including IRB*Data entering and verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)*Helping study monitors with CRA corrections (Hint: Using black ink, put a single line through incorrect information so that others can still read the original entry. Add signature and date of this change. Never use "white out" liquid correction fluid to make changes on regulatory or other documents including IRB and FDA forms.)*Maintaining study-specific supplies*Preparing for study closure and archiving Exibir menos

  • Research Associate

    Jan 2018 - Jan 2018

  • Research Fellow

    Jun 2015 - Jan 2017
• 

  IQVIA India

  Jan 2018 - now

  Provide oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines & project COP from Applications/ Analytics/ Therapeutics/ Quality perspective.Perform functional lead responsibilities for assigned project deliverables for specific customers.Attend Kick-Off meetings, weekly team meetings & client meetings, as needed or requested.Contribute and oversee to the development and use of study management plans, specific tools and document templates and other study specific plans to evaluate the quality and integrity of the study; including complete & accurate documentation so that the project is audit ready.Support project management team to develop monitoring strategy including monitoring triggers/thresholds.Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projectionsIdentify the value adds from the medical review & remote monitoring in the study & provide the inputs to relevant stakeholders.Early identification of site-level issues occurring during study conduct & responsible for identification of riskMonitor site performance & make recommendations for timely corrective actions via observing operational triggers/Key Data Points/data trends & monitor their compliance check by performing regular Quality Check.Evaluate the quality & integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.Establish & maintain effective project/ site level communications with relevant stakeholdersProject oversight to site management activities on assigned projects, evaluate the quality & integrity of the study as per the respective regulation & guidelines.Manage efforts of cross-functional project teams to support milestone achievement, study specific obstacles.Identify impacted areas, provide root cause, implementation of corrective & preventive action Exibir menos Working in parallel with Site Monitor to resolve site issues and providing centralized support to site.Holistic review of Clinical Trials data of sites and providing assistance to sites by Risk Based Monitoring approach and imparting critical analysis skills.Interpreting data, reports and trackers captured through various platforms to assess future risks and prepare mitigation plan accordingly.Interpret reports and draw trend analysis to identify root cause and develop corrective and preventive strategy to overcome that. Ensure Adverse Events and Protocol Deviations reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.Monitoring the conduct of Clinical trials at site remotely. Exibir menos

  • Associate Centralized Monitoring Lead

    Jan 2021 - now

  • Centralized Monitor

    Jan 2018 - Jan 2021