The following is an overview of what I would like to build upon. • Manage the Initiation, execution and development of Phase I-IV clinical trials including IND safety and efficacy, personal care, general safety testing, medical device testing, OTC efficacy testing, prescription/OTC pharmaceuticals, sensory testing to support claims substantiation and/or FDA submissions. • Ensures smooth and efficient study execution through the creation of detailed clinical study plans which include study flow, study setup, staffing, budget review, recruitment initiation, consent evaluation, creation of source documentation, binder setup and maintenance, study initiation and study closeout of clinical trials. • Applies FDA and GCP guidelines to all aspects of human clinical studies including but not limited to IRB submissions, informed consent procedures, handling of adverse events, statistical data analysis and interpretation to ensure safety and protection of study participants and intellectual property. • Provides study design consultation including protocol review to assist in determining what medical services and/or equipment are required for unique clinical trials e.g. EKG’s, Phlebotomy/processing specimens, vitals, medical staffing requirements/review of qualifications. • Reviews regulatory documents providing recommendations for simplification of documentation without compromising the capture of accurate data. • Determines and maintains study contractual resource needs through external liaisons with medical staffing services in order to deliver Sponsor agreed timelines. • Review, implemented and educate staff in state and federal workplace safety laws which resulted in 100% OSHA compliance. Specialties Sr. Clinical Research Associate/ Clinical Trial Manager, with extensive experience in the Medical Field. Experienced in managing, monitoring, coordinating, and executing Phase I-IV clinical trials for the Medical Device, Pharmaceutical and Consumer Products industries. Proficient in clinical trials management, study initiation, study execution, study documentation according to FDA and GCP guidelines. read more ...
  • University Of Phoenix
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  • Sr Cra At Monitorforhire.com

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