UNIV - Research Program Coordinator II - Department of Medicine: Division of Infectious Diseases

Medical University of South Carolina-posted 2 days ago
Full-time • Mid Level
Charleston, SC
5,001-10,000 employees
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Under the direct supervision of the MUSC-based Principal Investigator, the Research Program Coordinator II (PCII) will work with a study team located in South Africa to ensure rigorous conduct of clinical research trials of new therapeutics for tuberculosis. This position will involve international travel, mainly to South Africa. The duration and frequency of international travel is estimated at one 7-to-10-day trip approximately every 4 months, on average. This position requires independent decision-making and a high degree of professionalism. Entity Medical University of South Carolina (MUSC - Univ)

  • Lead an integrated quality management/quality assurance program for tuberculosis clinical trials conducted at the clinical site in South Africa.
  • Implement processes for monitoring study quality and progress, with emphasis on mycobacteriology laboratory results.
  • Oversee that protocol-prescribed processes are being implemented and adhered to among all sites.
  • Work with study team members to identify and resolve quality issues that are encountered.
  • Perform regular quality control for reported test results from the mycobacteriology laboratory to ensure accuracy and validity of reported results.
  • Serve as a liaison between the sponsor and the study team in South Africa in order to address issues and facilitate implementation of the clinical trial(s).
  • Lead regular video meetings between the sponsor, MUSC team, and South Africa-based teams.
  • Collaborate with the South Africa-based regulatory manager to prepare regulatory submissions to the South Africa-based ethics committees.
  • Organize and prepare regulatory submissions to the MUSC IRB.
  • Serve as the main point of communication with the MUSC IRB.
  • Manage and perform study-specific training for international site teams.
  • Participate in semi-annual meetings and other activities required by the sponsor (US Centers for Disease Control and Prevention).
  • Maintain appropriate certifications and credentials.
  • Conduct all research in adherence with the FDA Code of Federal Regulations "Good Clinical Practices" as well as MUSC IRB regulations.
  • Other duties as assigned which includes general duties to include answering phones, copying, filing.
  • A bachelor's degree and two years of relevant program experience.
  • At least 2 years of experience with study coordination and submissions to Institutional Review Boards/Ethics Committees.
  • Experience working in international settings is preferred.
  • Knowledge of tuberculosis is highly desirable.
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