I have 15 yrs. experience performing all aspects of Pharmaceutical Drug trials in Phases 1 thru 4 and have conducted many types of trials such as: Diabetes, COPD, Hypertension, Depression, HIV, HRT therapy, Bipolar I and II, Psoriasis, Thyroid disease and Alzheimers

Responsible for the management and conduct of all clinical trials contracted, from the CDA to the final Closeout and archiving of CRF and Regulatory documents * Responsible for all Protocol training and Protocol performance of all research staff including the study coordinators, research nurse, research assistant and medical assistants * Directly responsible for the administration of all Regulatory Affairs including study submission to the sponsor, IRB and contracted vendors; also maintaining protocol amendments, ICF amendments, IND reports, creating the initial 1572 and maintaining any updates or changes, continuing reviews, close out reports and all sponsor mandated documents * Lab manager for all study related lab kits and equipment * certified OSHA trainer and IATA certified for shipping hazardous waste * Study CRC responsible for the conduct and performance of many trials including PT and Monitor scheduling, PT recruitment, advertising, etc. * Worked directly in meetings with Sponsor representatives, Monitors, etc.

Responsible for the management and conduct of all clinical trials contracted, from the CDA to the final Closeout and archiving of CRF and Regulatory documents * Responsible for all Protocol training and Protocol performance of all research staff including the study coordinators, research nurse, research assistant and medical assistants * Directly responsible for the administration of all Regulatory Affairs including study submission to the sponsor, IRB and contracted vendors; also maintaining protocol amendments, ICF amendments, IND reports, creating the initial 1572 and maintaining any updates or changes, continuing reviews, close out reports and all sponsor mandated documents * Lab manager for all study related lab kits and equipment * certified OSHA trainer and IATA certified for shipping hazardous waste * Study CRC responsible for the conduct and performance of many trials including PT and Monitor scheduling, PT recruitment, advertising, etc. * Directly responsible for the hiring or firing of the research staff * Worked directly in meetings with Sponsor representatives, Monitors, etc.

responsible for the conduct, management and performance of the CNS trials contracted for BBH. My duties included all monitor visits, Lab manager, CRF data collection, study visit scheduling, attending all INV and/or training meetings * I would also oversee the conduct of recruitment, advertising, regulatory affairs and clinical operations relating to the trials.

responsible for the conduct, management and performance of the CNS trials contracted for BBH. My duties included all monitor visits, Lab manager, CRF data collection, study visit scheduling, attending all INV and/or training meetings * I would also oversee the conduct of recruitment, advertising, regulatory affairs and clinical operations relating to the trials.

Clinical Conduct Specialist responsible to Collaborate with the clinic staff on all shifts to insure the assigned studies were prepared and performed according to the protocol specifications * Clinic Scheduler responsible to oversee and manage the conduct of approximately 4 -5 simultaneous Phase 1 studies to insure appropriate staffing and training of 40 - 50Staff members.

Managed the draw station with all aspects of Phlebotomy from patient registration to processing the specimens to handling the proper distribution of laboratory results.

Delivered a 6 month class with 20 attendees that qualified them to take the certification examination. Instructed both didactic and clinical aspects of both disciplines of Phlebotomy and EKG