Principal

3 weeks ago

Bluffton, United States Medix Full time

We are seeking a Physician to work as a Principal Investigator at a clinical research site in Bluffton, SC. This person will have the opportunity to serve as a Principal Investigator as well as run their own private practice at this location

  • Maintain thorough knowledge of clinical trial protocols, HIPAA, GCP and ICH guidelines.
  • Maintain all Essential Documents in Investigative Site Files, whether electronic or paper filing systems.
  • Participate in recruitment and pre-screening activities including record review and mailing of Informed Consent Forms to potential subjects utilizing all resources available.
  • Carry out the Informed Consent Process and document as required by SOP.
  • Conduct study procedures in accordance with protocol, including measurement of vital signs, performance of ECG, questionnaires assessments, evaluation of subject diaries, adverse events, concomitant medications.
  • Create source documents and record all necessary clinic visit procedures and notes in these documents.
  • Dispense investigational medication, calculate compliance and maintain accountability records.
  • Report all adverse events, so that immediate patient care can be implemented and appropriate Safety Reporting can be documented.
  • Provide medical advice or care to participants as it pertains to the study.
  • Ensure that all the documentation for a trial has been recorded properly and accurately;
  • Help to identify research opportunities, assisting in preparation, application submission and ensuring study compliance and execution occurs once the study is approved.
  • Analyzes, recommends and supports practices seeking to improve performance on Quality Assurance (QA) measures to engage in work redesign, changes in research systems, policies and procedures, and quality improvement process within the department and organization.

Requirements:

  • MD or DO
  • Active SC medical license
  • Board Certification

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