Niharika Patel

Background

About Niharika Patel

Over 9 years of clinical research experience in a variety of roles, with 5+ years as a CRA • Experienced as a Lead CRA in Rare Disease and Gene Therapy trial • Trained in completing performance visit assessments for new CRAs and provide mentorship for those new to the role or CRO • Direct experience conducting all types of monitoring visits (i.e. PSV, SIV, IMV, and COVs) on phase pharmaceutical and post-market medical device and diagnostic studies as a blinded and unblinded monitor • Knowledge of and work in accordance with Federal Regulations, ICH Guidelines, and GCP • Proficient in various EDC, eRegulatory, CTMS and eTMF systems • Educated and experienced in proper study design, protocol development, and statistical analyses • Familiar with IRB submissions, correspondence, and reporting guidelines • Strong communication skills and attention to detail, fostering the ability to meet metrics and deadlines in a timely and consistent manner Therapeutic areas include: Gastroenterology, Infectious Diseases, Musculoskeletal, Oncology, Pediatrics, Psychiatry, Rheumatology, Rare Diseases, Vaccines, Gene Therapy