Karla Mcnutt Email & Phone Number

Kansas City, Missouri Area

Kansas City, Missouri Area

Alcon, A Novartis Division Fort Worth, TX

Oversaw pharmacovigilance activities including: reviewing and processing of adverse event reports in safety database for post-marketed pharmaceutical products. Report types include: literature, spontaneous, and Health Authority reports, POP cases (Patient Oriented Programs) and Phase IV clinical trials.Evaluated and assessed reported adverse event and.

Dallas/Fort Worth Area

Coordinated the research and administrative activities in support of projects for the Regulatory Affairs department utilizing CTMS (Clinical Trial Management System).Tracked sponsor-specific queries and resolutions and worked with regional regulatory coordinators to obtain updated documents and/or resolve pending queries.Assisted with study related.

Dallas/Fort Worth Area

Coordinated multiple clinical trials (National Institute of Mental Health, private foundation, industry sponsored and investigator initiated) for Phase III and Phase IV human subject clinical research studies.Managed assigned clinical trials to ensure that timing of major milestones met the trial plan which included providing clinical oversight and.

Dallas/Fort Worth Area

Coordinated multiple clinical trials (National Institute of Mental Health, private foundation, industry sponsored and investigator initiated) for Phase III and Phase IV human subject clinical research studies in accordance with Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs) as applicable to United States Food and Drug.

Bachelor Of Science (B.S.), Psychology

Psychology