Theertha Y C

Experience

• 

  MEYER ORGANICS PVT. LTD.

  Dec 2019 - Jan 2020

  Intern
• 

  IQVIA

  Jun 2022 - now

  Centralized Monitoring Assistant

  • Provide an i-Site Summary of all available non- QuORUM data sources to CRA to support monitoring activities and as per Trial Monitoring Plan.• Create QuORUM tasks highlighting potential risks and issues observed during Remote Data Review.• Local Study Team (LST) presentation and email communications for the assigned sites and countries.• Conduct periodic review of site level Key Risk Indicators (KRIs) and historic site performanceaccording to Central Monitoring Plan.• Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk.• Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit)• Proficient in identifying discrepancies and review the effectiveness of the recommended actions.• Work in accordance to the Study Central Monitoring Plan.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.• Establish and maintain effective project/ site level communications with relevant stakeholders.• Maintain relevant project documents.• Collaborating with peer business process specialists and promoting cross functional synergies.• Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.• Attend Kick-Off meetings, weekly team meetings, and client meetings, as per the project specific needs.• Ensuring work carried out in accordance with corporate quality standards, global data management plan, SOPs, ICH-GCP and other regulatory requirements. Show less