Knowledgeable and compassionate Nursing staff member with 2+ years of medication administration experience with a strong medical background and a compound exposure to all phases of research from feasibility to close-out. Diligent about serving all facets of patient medical and personal needs while assisting medical staff with meeting critical needs. Comfortable working efficiently under pressure in team setting. Excellent communication and organizational skills combined with dependable, inquisitive and forward-thinking approach.
Training on Good Documentation practices according to the ICH-GCP guidelines.
Knowledgeable on the process of pre-screening, obtaining informed consent, and screening of subjects.
Handling and organizing regulatory binders.
Obtaining, recording and adequately reporting Adverse events and Serious adverse events
Knowledgeable on some essential FDA regulations such as 21CFR part 11, 21CFR part 50, 21CFR part 54, and 21CFR part 56.
Understands the description and various parts of a study protocol
Understands the roles of various players involved in a clinical trial
Achieved a strong background in fundamental sciences like biochemistry, Anatomy, Physiology, pathology, Molecular biology, Cytology/Histology, Genetics, Immunology, chemistry, biophysics, bio statistics and public health sciences
Developed Good and broad clinical knowledge and skills in disciplines like Internal Medicine, Surgery, Pediatrics, Obstetrics-Gynecology, Ophthalmology, Ear-Nose-Throat, Radiology and Anesthesiology.
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