Pooja Chavan

WORK HISTORY

EDUCATION

ABOUT POOJA CHAVAN

Goals: To achieve a position of accountability in an organization of excellent concern, which would provide challenging work environment and allow me to grow both professionally and individually by utilizing my skills and abilities in the organization.Areas of expertise- India and many European countries - Ethics, R&D (CSP) and Regulatory submissions- Creation of Information Sheet And Informed Consent Form and site specific documents according to local specificities and regulation- Clinical trial tools: IMPACT, ICOtrial, Oracle e-Clinical, e-Room, eDM, e-Diary, Medidata rave, InForm, Intralink, SAP- Interactive Voice/Web Response Systems: Clinphone, ALMAC- SWAT, On-Site, Remote and Risk based monitoring activities for all visit types within NHS Trusts, Primary Care Trusts and private care settings- Line management, Sign-off new CRA, CRA mentoring and training- Negotiation and execution of European sites Clinical Trial Agreements and budgets, Vendor management- Worked as a study coordinator, in-house CRA, CRA and LCRA which helped to understand the techniques, working process, difficulties faced at each level and how to tackle those difficultiesTherapeutics Areas worked on:OncologyGastrointestinalCardiovascularOrthopedicsRespiratoryEndocrineLeukemiaPediatrics studiesWide experience of working in all Phases of Clinical Trial including post marketing studies. Also worked on Phase II and trial of vaccines.Countries- India, Singapore, Bangladesh, UK, Ireland, France, Spain, Italy, Sweden, Netherland, Germany, Austria, switzerland, Portugal, Denmark, Belgium, US, CanadaAttended many Regulatory Inspection and many Audits with minimum observation as a CRA.