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Job #02862

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 Clinical Research Associate/Telephone Monitor (Home-Based) East Coast and Southeast Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform monitoring (telephonic) visits to sites that have studies in the long-term follow-up stage 2) Prepare and send visit preparation worksheet to the site prior to visiting so as to facilitate visit activities 3) Perform site management in conjunction with the Field CRA assigned to the same site 4) Facilitate the collection of expired regulatory documents 5) Work closely with site personnel and study personnel on meeting project timelines 6) Facilitate quality, accuracy and complete reporting of clinical events as well as data by the investigational sites 7) Take initiative in identifying project-specific site training needs to ensure site compliance 8) Perform (independently) investigational site training on study and regulatory requirements related to the conduct of a clinical trial and investigator obligations through monitoring visits, query resolution and deviation reporting 9) Assist data management/safety in collecting trial data from the investigational sites 10) Contribute actively to the resolution of CEC and DSMB required information 11) Perform (independently) investigational site qualifications, initiations, monitoring and closeout visits (as per SOP, GCP, etc.) within the timelines required by the clinical divisions 12) Write reports and send follow-up letters to the site after the visit Requirements 1) Bachelor’s degree in Science or a healthcare-related field (Master’s degree preferred) 2) 3 – 6 years of experience in clinical/scientific research 3) Medical professional experience 4) 3 – 4 years of monitoring experience in medical devices (pharma/biotech can be considered) 5) Knowledge of CRF 21 6) Proficiency in computers 7) Willingness to travel (5% – 10%)