Experience

• 

  Clinstar, llc

  Feb 2012 - Dec 2012

  Clinical research associate i

  Full CRA responsibilities.

• 

  Pra health sciences

  Jan 2013 - Aug 2018

  As Sr. CRA managed numerous sites in 7 studies in Infectious diseases, Gastroenterology, Rheumatology and Oncology. Responsible for supervising other CRAs. Schedules and reviews trial tasks, provides leadership in the delivery of services to clients. As CRA II managed numerous sites in 6 studies in Urology, Infectious diseases, Endocrinology, Rheumatology, Pulmonology, Pediatrics. All site-related activities, including but not limited to the Feasibility, PSSVs, SIVs, IMVs, COVs, site management and TMF keeping, payments calculations and management.

  • Senior Clinical Research Associate

    May 2016 - Aug 2018

  • Clinical Research Associate II

    Jan 2013 - Apr 2016
• 

  Msd

  Aug 2018 - now

  Working at Fortrea under contract with MSD Pharmaceuticals. • Project Management responsibilities, driving clinical trials execution. Ensuring that clinical studies are effectively conducted and completed within budget, timelines and meeting enrolment commitments;• POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols;• Ensuring operational excellence within clinical trials across relevant indication in country. Ensuring operational efficiency and quality for MSD;• Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed;• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Show less Working at Covance under contract with MSD Pharmaceuticals, driving Start-up Cycle time for MSD. • Collaborate closely with Regional Operations and Headquarter to align country timelines for assigned protocols. Provide support and oversight to local vendors as applicable. • Ownership of country and site budgets, financial forecasting and tracking of operational budget. • Provide an oversight and tracking of clinical research-related payments. • Development of local language materials including local language Informed Consents and translations. • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. • Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction and insurance process management. Show less

  • Clinical Research Manager

    May 2021 - now

  • Clinical Operations Manager

    Aug 2018 - May 2021