Vijayakumar .S

I have 9 years of experience in clinical research Good understanding of FDA and international regulations and Guidelines. Comprehensive knowledge of Medical terminologies, Disease conditions, Medications, Lab reference ranges, GCP, TMF, eTMF, drug safety, SUSAR, clinical trial, ICH, IEC, guidelines and regulations. In-depth knowledge of ICH safety reporting regulations and guidelines. Familiarity with the research process for drug trials and providing treatments to research patients. Good knowledge about the Clinical research standard operating procedures. Worked directly with CRA & assisting in close-out visits. Great ability to provide direction, to serve people, to develop a relation with the subjects and maintains the favorable public relation. Excellent communication and demonstration skills. Good analytical, problem-solving and time management skills