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Job #02762

About our client Our client is a leading medical device company, which is focused on the development and commercialization of less invasive medical devices and procedures. Position Location Regional Clinical Research Associate (In-House) Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Track screening and enrollment 2) Identify issues and address them globally 3) Confirm (independently) that site regulatory documents match TMF and act as an expert on subject matter for junior staff 4) Contact sites on a consistent basis to assess study compliance and mentor junior colleagues 5) Address non-compliance issues at investigative sites and develop CAPA (if necessary) 6) Note global trends as a functional lead and report to project management 7) Develop a project plan for Long Term Follow-up (LTF) projects 8) Manage deliverables 9) Disseminate project information 10) Manage budgets 11) Lead Clinical Team meetings on LTF studies under the guidance of senior project management 12) Track metrics data 13) Monitor CRFs against medical records on complex trials 14) Prepare and assist the CRA on the preparation of confirmation letters, site-visit reports and follow-up letters 15) Mentor junior staff on the conduct of site closeout visits 16) Conduct site initiation and qualification visits along with mentoring junior staff on completing these visits 17) Assist junior staff in scheduling monitoring visits to ensure that project timelines are met and the monitoring plan is followed 18) Participate in study-specific teleconferences and investigator meetings 19) Mentor junior staff in conducting device accountability at investigational sites and assist in resolving issues 20) Train new study coordinators and junior monitors on ICH/GCP guidelines and study-specific requirements 21) Coach junior staff in identifying adverse events during monitoring and ensure that sites complete appropriate reporting 22) Review summaries of medical publications and previous study summaries 23) Deliver high-quality clinical input to core teams 24) Prepare portions of protocol under the guidance of Project Manager 25) Utilize clinical knowledge to improve clinical compliance across departments and at external sites having compliance issues 26) Mentor CTC, CRAs and new employees 27) Guide the development of new employees and junior staff 28) Handle site CAPA process and re-training 29) Lead more complex studies 30) Participate in start-up activities Requirements 1) Bachelor’s degree in Science/healthcare-related field (Master’s degree preferred) 2) 3 – 8 years of experience in clinical/scientific research or as a medical professional 3) 1 – 2 years of monitoring experience in medical device preferred (Pharmaceutical/Biotechnology can be considered) 4) Willingness to travel (20% to 25%)