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Title Sr. Clinical Research Coordinator
Target Location US-OH-Cincinnati
Email Available with paid plan
Phone Available with paid plan
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Candidate's Name
Street Address  Knollwood DriveTaylor Mill, KY Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLEOrganized and motivated employee with 18+ years experience in the healthcare profession. I have been employed by a Research facility for the last 7 years. I am able to apply organizational skills in various environments and seek employment in a professional atmosphere.EXPERIENCEFebruary 2019-CURRENTWellnow Urgent Care & Research, 10575 Springfield Pike Cincinnati, OH- Clinical Research CoordinatorInitiate research protocols, implement new technology, monitor patientsOversee the clinical trial protocol, CRFs, and informed consentUpdate departmental procedures and legal requirements to keep the team and department currentPrepares IRB submissions including continuing reporting, reportable events, amendments and follow ups to IRBMaintain confidential HIPAA standards with all Patient documentsAscertain all FDA and IRB policies are met in relation to various protocolsEnsure coordinator and investigator compliance with GCP and ICH guidelinesProduce site-specific advertising materials using Sponsor and IRB approved languageTrain CRCs, nurses, and clinical staff on clinical trial processes and protocol guidelinesCreate source documents for various protocolsMaintain all required documentation for the study protocol and for FDA regulations ensuring accurate completion of all technical requirements.Serve as main point of contact for study related questions including subject eligibilityProcess specimens study specific per protocols, package and ship specimens per protocolEnsure study medication is kept secure and under the appropriate temperature conditions and maintain accurate study drug accountabilityNovember 2015-February 2019Medpace, 5355 Medpace Way Cincinnati, OH- Sr. Research AssistantAssist with study participant screening, admission, orientation, informed consent, conduct, and dischargeDemonstrate technical skills in Phlebotomy, laboratory specimen collection, ECGs, vital signs, drug screens and other protocol related proceduresProcess specimens study specific per protocols, package and ship specimens per protocolPerform routine lab and exam room maintenance such as equipment calibration, waste disposal, and preparation of patient areasNotify appropriate project team members of study participant Adverse Events in a timely mannerFollow proper safety and emergency policies and procedures, and notify direct supervisor of potential work hazardsMaintain accurate and legible logs and tracking sheetsMaintain study specific documentsTrain new employeesWork side by side with Investigators and Pharmaceutical sponsorsAssist in the overall process of clinical trialsAugust 2005-February 2011St. Elizabeth Medical Center, 1 Medical Village Drive Edgewood, KY- PhlebotomistMaintained patient lab workOccupied positions at Inpatient, Outpatient, and Nursing HomesCollected blood and other specimens for multiple ranges of testingAugust 2001-July 2005Cardiology Associates, 900 Medical Village Drive Edgewood, KY-ReceptionistMaintained scheduling of patientsAssisted with co-pays, registration, and medical recordsEDUCATIONMay 2001-May 2002Southwestern College, Florence KY- PhlebotomyReferences Available Upon Request

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