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Job #02809

About our client Our client is a leading medical device company, which is focused in the development and commercialization of less invasive medical devices and procedures. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Regional CRA (Home-Based) Missouri, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Track screening and enrollment as well as identify issues to be addressed globally 2) Confirm (independently) that site regulatory documents match TMF 3) Act as an expert on subject matter for junior staff and mentor junior colleagues 4) Contact sites on a consistent basis to assess study compliance 5) Address non-compliance issues at investigative site, develop CAPA (if necessary) and mentor junior staff 6) Note global trends (as a functional lead) and reports to the project management 7) Develop project plan on Long Term Follow-up (LTF) project 8) Manage deliverables 9) Disseminate project information 10) Perform budget management 11) Lead Clinical Team meetings on LTF studies under the guidance of the Senior Project Management 12) Track metrics data 13) Monitor CRFs against medical records on complex trials 14) Write/make confirmation letters, site-visit reports, follow-up letters as well as assist the CRA on these tasks 15) Mentor junior staff on the conduct of site closeout visits 16) Conduct site qualifications visits and initiation along with mentoring junior staff on completing these visits 17) Assist junior staff in scheduling monitoring visits 18) Ensure that project timelines are met and the monitoring plan is followed 19) Maintain presence at study-specific teleconferences and Investigator meetings 20) Mentor junior staff in conducting device accountability at investigational sites 21) Assist in resolving issues 22) Train new study coordinators and junior monitors on ICH/GCP guidelines and study-specific requirements 23) Review summaries of medical publications and past study summaries 24) Train junior staff in identifying adverse events during monitoring 25) Ensure that sites complete appropriate reporting 26) Deliver high-quality clinical input to core teams 27) Write portions of protocol under guidance of the Project Manager 28) Utilize clinical knowledge to improve clinical compliance across the department and at external sites 29) Mentor CRAs, clinical trial coordinators and new employees 30) Guide the development of new employees and junior staff 31) Handle site CAPA process and re-training 32) Lead complex studies 33) Participate in start-up activities Requirements 1) Bachelor's degree in Science or healthcare-related field (Master’s preferred) 2) 3 – 8 years of experience in clinical/scientific research 3) 4 – 5 years of monitoring experience 4) Previous experience in working as a medical professional 5) Medical device experience preferred (pharmaceutical/biotech experience can be considered) 6) Willingness to travel – up to 50%