UNIV - Research Program Assistant - Surgery: Clinical Trials

Medical University of South Carolina•Charleston, SC
•$37,944 - $60,690•Onsite

About The Position

The Clinical Research Assistant is responsible for coordination of investigator-initiated transplant studies for the Department of Surgery as directed by the Principal Investigator. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices", and adhere to the MUSC IRB regulations for the protection of human subjects.

Requirements

  • A high school diploma and four years of relevant program experience.
  • A bachelor's degree may be substituted for the required program experience.

Responsibilities

  • Ensure study-required clinical elements and tests are conducted and collected according to the protocol.
  • Conduct simple study visits per study protocol.
  • Obtain and document informed consent under the direction of the Principal Investigator.
  • Maintain accurate informed consent documents for later review.
  • Screen and prescreen potential patients for their assigned research studies.
  • Maintain screening and enrollment logs, as required, and provide periodic updates to the study team.
  • Complete case reports forms and other source documents in a timely manner.
  • Create simple data collection forms, when required, to capture protocol specific data.
  • Perform simple data entry to study databases in a timely manner.
  • Be responsible for the resolution of study specific queries within the EDC system.
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