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clinical research coordinator
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CLINICAL RESEARCH COORDINATOR II

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Envision Physician ServicesPlano, TX
Full-time
  • We currently have a great opportunity for a Clinical Research Coordinator II opportunity at our corporate offices in Plantation.
  • The Clinical Research Coordinator II is responsible for conducting pharmaceutical sponsored studies and overseeing the work of other clinical research coordinator I. Responsibilities Conduct pharmaceutical sponsored studies in accordance with FDA regulations and Good Clinical Practice guidelines.
  • Established in 1953, our organization provides anesthesia, emergency medicine, hospital medicine, radiology, primary/urgent care, surgical services, and women’s and children’s health services to hospitals and health systems nationwide.
  • Responsible for overseeing recruitment and screening activities to ensure enrollment goals are met and budget items are reported to the Project Manager for invoicing and collection Ensure that all study Regulatory documents are filed properly and timely throughout duration of the trial Quantify and prepare Site for CRC readiness for site visits (SQV, SIV, IMV).
  • Communicate with monitor/IRB/lab on assigned protocols Participates in monitoring visits scheduled by sponsor for assigned protocols Read, respond and file all information regarding assigned protocols, including regulatory documents, and Sponsor correspondence and data clarification requests.
  • Recognize and report AE’s and SAE’s to physicians, supervisor, IRB and to Sponsor as required by protocol Prepare and submit additional reports: serious adverse events, screening logs etc.
  • Supervise daily operations of CRC at their site and report entity activity to the Project Manager daily.
  • Handle all responsibilities of patient recruitment (call patients back in a timely manner from ad responses, hangs IRB approved posters in community areas, visit referring doctors for recruitment and health fairs etc.)

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