Job Title:
Clinical Research Auditor
Job ID:
438643
Location:
College of Medicine
Department:
COM-Office of Research
Full/Part Time:
Full-Time
Regular/Temporary:
Regular
Shift:
Shift Varies
FTE %:
100
Salary Range Min:
$18.57
Salary Range Max:
$27.36

Position summary

Clinical Research Auditor (Job Opening 438643) - The Clinical Research Auditor audits the accuracy of clinical research to ensure protocol and regulatory compliance for the College of Medicine clinical trials program and investigator initiated clinical research; conducts compliance assessments of research conducted within the college; provides feedback to key stakeholders regarding audit results and may recommend necessary steps to resolve any identified compliance issues and development of correction action and preventative action plans; keeps detailed records of all audits conducted along with audit results, recommendations, and follow-up activities to ensure action is taken; works in conjunction with the College of Medicine Office of Research to develop training materials and conduct training workshops as needed; maintains detailed knowledge of applicable University, State, Federal, International regulations and Good Clinical Practice (GCP) guidelines pertaining to research in human subjects; disseminates educational materials, regulation and policy updates; collects and analyzes data to support the research compliance plan; and performs other duties as assigned to support the COM Office of Research compliance activities.

Education and experience

Bachelors degree in biological sciences, health sciences or equivalent combination of education & experience required; experience in a progressively responsible clinical research or administrative capacity required; considerable knowledge of clinical research regulations, guidelines & compliance issues required; travel required approximately once per month initially with potential for more travel in the future; experience developing informed consent documents & preparing regulatory documents desired; experience & knowledge of IRB, federal & industry sponsor processes & requirements preferred. Requires successful completion of a background check; qualified candidates may be asked to complete a pre-employment physical including a drug screen.