Professional Summary A certified professional Clinical Research with 4 years of experience in Clinical Research coordination and a year experience as Clinical Study Associate. Expertise in QC of documents, remote Monitoring and supporting the management by handling the tasks of multiple clinical research studies managing eTMF's & designing Clinical Portfolio's from Sponsor end. Expert in liaising between different departments. An overall 12 years of experienced in Health care& Research Industry . Areas of Expertise * Remote Monitoring * Project Planning Project Management * QA & QC of study related documents * Phase I - IV Clinical trials In -Vitro Diagnostics, In-Vivo Diagnostics * Device Trials - Pharmajet * EDC - RAVE, Vault eTMF TESLA, QUEST, Sharepoints, IMPACT, Cognos, SMART * Medical coding MeDra and WHO ICD 9&10 * Pharmacovigilance & safety management * Audits and Inspection readiness * Clinical Monitoring * Remote site Evaluations * Document Compliance QA & its management from Sponsor end * Therapeutic areas in research : Genetic studies of neonates Pediatric GIT Oncology Metabolic Infectious Diseases Gynaecology and obstetrics, Immunology Accomplishments * Compliance - Maintained compliance with regulatory standards * Gold medalist in Graduate College at all University level Examination * Played a key role in conducting Device trial research and experiments that concluded in FDA submission. * Leader in the planning and achievement of goals and objectives consistent with the agency mission, philosophy, goals and objectives. Skill Highlights * Pharmacovigilance Safety Report * Staff Training Team Collaboration * Effective Multitasking Accomplishments * Compliance - Maintained compliance with regulatory standards * Gold medalist in Graduate College at all University level Examination * Played a key role in conducting Device trial research and experiments that concluded in FDA submission. * Leader in the planning and achievement of goals and objectives consistent with the agency mission, philosophy, goals and objectives. Skill Highlights * Pharmacovigilance Safety Report * Staff Training Team Collaboration * Effective Multitasking

Highlights:

• Document Management
• Monitoring - Remote and onsite
• Clinical Research coordinator
• Device trials, clinical Research
• Project Management
• QC and QA
• Pharmacovigilance
• Ethics and compliance, regulatory
• Clinical study Associate
• Multiple therapeutic areas experience
• Phase 1-4 trials
• Audits and Inspection readiness
• Multiple software and application experience - Veeva VAULT , Impact , Quest , Sentinel,Tesla
• EDC experience- RAVE Medidata
• IRT system experience Clinpace , Endpoint