medical writer
self-employed
Total years of experience :14 years, 8 Months
medical writing, online protocol formulation and review
Implementation of projects and clinical trials, project management, checking their compatibility with ICH-GCP and Schedule-Y guldelines, training Clinical Research Coordinators, verification of Source douments, leading Research coordinator team etc.
• Patient counseling and recruitment to clinical trials
• Site source document verification and monitoring
• Communicating with Project Manager, Principal Investigator, Subjects & Ethics committee
• Negotiating with Contract Research Organisation, Pharmaceutical Companies and Sponsors on behalf of the Principal Investigator.
• Know and follow the study protocol
• Maximize trial subject protection and data quality
• Maintain good trial files and archives
• Meticulously document product accountability
• Ensure timely & efficient safety reporting
• Check patient visit
• Filling up e-CRF (e- Case Report Form) and IVRS ( Interactive Voice Response System) processing
• Cooperating for auditing and monitoring
• Ensuring that the work done by Clinical Research Coordinator is up to the mark
• Check overall safety, quality and efficacy- compliance to ICH-GCP and Schedule Y guidelines.
• Patient counseling and recruitment to clinical trials
• Communicating with Project Manager, Principal Investigator, Subjects & Ethics committee
• Know and follow the study protocol
• Maximize trial subject protection and data quality
• Maintain good trial files and archives
• Meticulously document product accountability
• Ensure timely & efficient safety reporting
• Check patient visit
• Filling up e-CRF (e- Case Report Form) and IVRS ( Interactive Voice Response System) processing
• Cooperating for auditing and monitoring
• Check overall safety, quality and efficacy- compliance to ICH-GCP and Schedule Y guidelines.
• As a Siddha medical practitioner, treating patients as per Siddha principles and teaching them the Siddha way of life.
Master of Science in Clinical Research and Regulatory Affairs including subjects like clinical operations, clinical data management, regulatory affairs,project management, IPR, biotechnology, pharmacology, medical writing etc
Bachelor of Siddha Medicine and Surgery-Indian system of Medicine which included subjects like Human Anantomy and physiology, Biochemistry, Medicinal Botany, Siddha Pharmacology, General Medicine, Special Medicine, Surgery, Forensic medicne , Basics and fundamentals of Siddha system of medicine etc University Gold medalist in all 5 years Represented Kerala State and presented four papers in National Seminars in Siddha.
Higher secondary education in science group Best All Rounder Oratorical contest winner won many prizes in elocution, drawing and painting and dance
Basic school education from Kindergarten to tenth standard Won many prizes in science exhibitions, elocution, drawing and painting and dance contests Attended National Integration camp representing Kerala State twice