Sufficient Bien

Background

About Sufficient Bien

Clinical Research Coordinator, experienced in patient informed consenting process and procedures (informed consent), patients study recruitment, prescreening and screening of subjects into clinical research studies. IP administration, subjects follow up and retainment, subject safety and adherence to study protocol. Data integrity, EDC data entry and Data management. Study start up and close outs. Regulatory processes, filing and proper documentation. Experienced with EMR and paper charts. Clinical Research Professional with diverse clinical and Health care background including: General Medical Practice, Clinical Health Care Management, IV Certified. Registered Medical Assistant, Registered Phlebotomy Technician, Registered Electrocardiography Technician, BLS/CPR and ACLS. Currently working with Florida Cancer specialist GDP Certified and TransCelerate Approved. I have experience in the ICH GCP E6 guidelines and the FDA regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46. I have knowledge and experience with management, training, compliance, and regulations pertaining to clinical research and general patient management. I aspire to improve public health and quality of life, through clinical research. I am Enthusiastic, detail-oriented Focused, great team player with excellent organization and problem-solving skills. A fast learner with a wide range of technological skills and experience in healthcare software programs.