Amy Chinyere
Senior Clinical Research Associate @ Kato Pharmaceuticals | Health Informatics
- Role
- Senior Clinical Research Associate at Tenpoint Therapeutics, Ltd.
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Amy Chinyere
Over 10 years of clinical research experience in Phase clinical trials with excellent knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements. •Detail oriented, excellent organizational, communication and interpersonal skills. •Therapeutic experience: Autoimmune, Central Nervous System, Circulatory, Dermatology, Digestive, Endocrine, Metabolic, Musculoskeletal, Oncology/Hematology, Respiratory, Sense organs, Ophthalmology, Infectious Diseases, Vaccine and Women Health. Available for Contract monitoring, remote data entry/query resolution, SWAT team. •. Nine (9) years’ experience in a clinical research environment. • Therapeutic Experience with Phases I, II & • Progressive On-site monitoring experience with PSSV, SIV, IMV, COV • Strong experience with GCPs, FDA regulations and ICH guidelines • Strong leadership and interpersonal skills • Excellent oral and written communication skills • Strong problem-solving skills • Excellent self-management, organizational skills and detailed oriented • Computer Skills: MS Office, InForme, Datalabs, Rave, Safe, Trial Master (EDC), IMPACT, Homegrown, Siebel, Paper (CTMS
Experience
Senior Clinical Research Associate
Jan 2022 — Present · Irvine, CA, US
Education
The University of Texas Rio Grande Valley
Master's degree
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