Jyoti Suryavanshi

Quality Assurance Analyst @Omega Healthcare Management Services

Navi Mumbai, IN

Responsible for the management of designated oncology clinical trials, preparation of trial related documents as per protocol and case report forms (CRFs).Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database.Ensure the queries generated during cleaning are responded in a timely fashion and in compliance with ICH-GCP guidelines.proficient in the knowledge of protocol monitoring activities.ensure that the data is clean correctly updated as per guidelines before monitoring visits. Ensure the conduct of trial is following the currently approved protocol amendment.Participate in global conference calls and PI meetings to review progress of ongoing clinical trials. review IRBs, registration protocols, adverse events and serious adverse events (SAEs) and identify any deviations in the protocol process.Interpret the gathered data and determine how their health facility could better serve their patients and identify the area of improvement. working on EMRs and EHRs.(Epic, Nexgen,GEcentricity, Eclinical works, Rave, redcap, CTMS oncore, Inform, medrio, CRDB, zelta imedidata, EAdvantage EDC,Mayo clinic,PIMS,CTS.Escalate performance concerns and issues as needed.Assists with retraining of underperforming staff.constructs corrective action plans (CAPA) for MDAs with recurring errors.

Mumbai University Mumbai

Bachelor of Pharmacy - BPharm