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SKILLS Medical Education Public Health Good Clinical Practice (GCP) Clinical Trials Data Collection Healthcare Management Advanced Life Support (ALS) Basic Life Support (BLS) Medical Research Clinical Data Management Regulatory Affairs Timelines Management Regulatory Compliance Practice Harmonization Trial Monitoring Data Verification Technical Trial Reports Study Documentation Protocol Development Quality Control Electronic Data Processing Trial Methodologies Trail Study Center Setup Protocols Development Investigator Identification Pre-trial Procedures Research and DevelopmentEDUCATION Master of Orthopedics and Traumatology,Kmapo University, KIEV Mar 2005 Diploma in Hospital Administration, Salem,Tamil Nadu, India 2008 MBBS (Bachelors of Medicine and BachelorsOf Surgery), Pgims, Rohtak, India Dec 1993REFERENCESAvailable Upon RequestCONTACTNew York, NY 10065PHONE NUMBER AVAILABLEEMAIL AVAILABLEOBJECTIVEHighly skilled Clinical Research Associate with over twenty years of experience in the medical industry. Proven success in designing, conducting, and managing clinical trials from start to finish. Knowledge of the clinical research process including ICH/GCP guidelines and federal and local regulations. Well-versed in coordinating operations, managing sites, and drafting detailed clinical reports.CORE QUALIFICATIONS Ability to successfully manage all aspects of clinical studies from start to finish, including recruiting patients, monitoring trials, and compiling data. Profound knowledge of ICH-GCP and other relevant regulatory requirements. High knowledge of ICH guidelines, SAE reporting, and GCP auditing. Adept at analyzing complex data sets and identifying opportunities to enhance the quality of clinical research initiatives. Solid knowledge of EDC, CTMS, eTMF and other software used in clinical trials. WORK EXPERIENCEPod Leader and Quality Assurance Manager Aug 2022 - Present MedElite, New York, NY Managing long-term care of facilities. Hiring and training of RNs, NPs, and LPNs for field visits. Data analysis on EMR systems like PCC, Epic, Visual EMR, Matrix, etc. Senior Medical Officer 2015 - 2021Poly Clinic, Sonipat, Government Of Haryana Covid-19 management. Supervision of various hospitals during the Covid-19 pandemic Performed medical examinations and evaluations, including the interpretation of test results; diagnosis of disease or injury; treatment plans for patients with emphasis on primary care services. Prescribed medications, treatments, diagnostic procedures, and follow-up care as appropriate to address patient needs.Civil Hospital 2005 - 2015Government Of Haryana Management of 100 bedded hospital. Interdepartmental coordination. Participated in research projects within the hospital or university setting that involved clinical trials testing new drugs or devices designed to improve patient outcomes after surgery. Conducted thorough exams and ordered necessary tests for patients with symptoms that could be indicative of serious conditions.Community Health Centre Dec 1999 - 2003Government Of Haryana National Malaria Eradication Program. Revised National Tuberculosis Control Program. National Polio Eradication Program. Universal Immunization Program.TRAINING National Disaster Management Training, Government Of India Assessing the impact of various man-made and natural disasters Mitigating the impact of disasters Rehabilitating the affected people RNTCP Training, Government of Haryana, India Training on new trends in Tuberculosis and their management NMEP Training, Government of India Studying new guidelines from WHO on Malaria and the management of the disease HIPAA Training, Government of India Training by Haryana Institute of Public Administration Management of various health programs |