Research Compliance Analyst I
About the position
Requirements
• Bachelor's degree
• 2 years of experience in research regulatory compliance
(e.g., Clinical Research Coordinator), human subject protection, institutional review board, research ethics, research compliance and/or a related field.
• Proficiency with all Microsoft Office programs.
• Strong computer proficiency including experience with research-related databases and software systems.
• Critical thinking, analytical, and problem-solving skills with exceptional attention to detail to apply specialized expertise to achieve results.
• Excellent verbal and written communication along with excellent interpersonal skills to cultivate relationships & produce optimal results.
• Self-driven- taking initiative for continuous quality improvement and professional development.
• Assessment/analysis/evaluation of complex clinical research protocols and accompanying regulatory materials.
• Ability to manage multiple tasks concurrently - prioritizing & executing. Accountability to set and meet timelines/deadlines.
• Ability to thrive in both a heads-down, independent work environment as well as work on team projects collaboratively.
• Understanding of the multiple regulatory frameworks governing conduct of research (e.g., OHRP, FDA, HIPAA, NIH).
• Understanding of regulations and their application in research.
Nice-to-haves
• Master's degree in Biological/Life Sciences or other field related to research and/or health care
• Clinical experience or working knowledge of clinical medicine (e.g., terminology, workflows)
• Experience in a healthcare/health system centralized/shared service infrastructure environment.
• Academic and/or academic medical center work experience.
• Experience conducting and/or formal oversight of human subject's research.
• Post approval monitoring.
• Project management.
• Policy development.
• Current research professional certification (can be any certification, but these are preferred: Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified in Healthcare Research Compliance (CHRC), or Certified IRB Professional (CIP))
• Proficiency with research-related platforms/software (e.g., REDCap, Qualtrics, IRB submission systems) Epic proficiency - specifically research functionality
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