Description
A Clinical Research Associate position with a pharmaceutical / biotechnology firm that utilizes my training and experience in clinical research to coordinate, monitor and manage all aspects of clinical studies in accordance with the ICH, Good Clinical Practices, FDA guidelines, local regulations and the standard operating procedures to work as part of a team to reduce the time it takes for a new drug or device to go from NID through NDA to the market. STUDY COORDINATORY EXPERIENCE * Previous Experience: Performed the duties of a Study Coordinator (CRC) with several SMOs, doing multi-specialty studies, Phases I-IV, prior to taking on the training and responsibilities of a CRA. 1994 - 2016 Employed in a Phase I facility for one year as a CRC. * Perform all functions necessary for accurate completion of research study protocols recruitment, scheduling, obtaining complete and accurate medical history, clinical assessment of study subjects, laboratory requirements/specimen collection and processing, procuring diagnostic procedures and reports for Investigator review and assessment. Any Regulatory Requirements for Studies. * Function as the primary point of contact between the investigators, site personnel and the pharmaceutical company/sponsor representatives, project managers and monitors delegated to each study. * Receipt, preparation, dispensing, and accountability of all investigational products received at the investigational site. * Laboratory collections of all specimens on my studies. Prep and shipping as necessary per the study guidelines. * Overall organization and logistics of all study related procedures and visits for up to twelve studies. EDC and paper CRFs data collection experience. HEALTH CARE EXPEREINCE: * RRT- worked in the field of Respiratory Therapy as a staff Respiratory Therapist, PFT Technician, Shift Supervisor and as a Department Head. Performed PFTs, Blood Gases, Blood Gas Machine calibration, monitoring Ventilators in the ICU, Pedi ICU, and NICU, machine calibration, Staffing Duties, etc. * Transport teams as well as a team member of Life Flight for the Neonatal Intensive Care and Trauma Transports. * Performed Home care tasks with Hospice and local healthcare companies. Home health with the Respiratory Care portion of the hospital to maintain home provided ventilators and oxygen therapy * Worked with a Plastic Surgeon on call in the operating room/surgery center performing face lifts, breast implants, tummy tucks and liposuction, Recovery room in the Surgical Center and private duty home care of surgical patients once they were discharged home. This was for (7) seven years. Also, administered medications via orally, injections, and Intravenous injections for pain and antibiotics. * Worked as the office nurse for an Urologist/Nephrologist for nine (9) years. Performed all office transcription during this time and all required procedures for the medical staff per the patient needs and Physician's orders, prostate ultrasounds and biopsies, ED testing, cauterization, stint removals, bladder ultrasounds. * Worked for several Family Practice/Internal Medicine physicians as the office nurse. Blood pressure checks, labs, OB-GYN procedures and ECG. Ordered required studies for diagnostic purposes, i.e. ultrasounds and phoned in orders for prescription refills to the pharmacy on file, call backs to patients when necessary. * Owner and Manager of a Portable X- Ray/EKG Company, Halter Monitoring, Respiratory In-services. Managed a staff of six to eight (6-8) employees while company was still working. Processed all medical claims, Medicare, Medicaid, second and third party billing and insurance. Liaison for office with Medicare and Medicaid.
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