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Posted: Wednesday, April 26, 2017 12:56 AM

The Research Compliance & Education Specialist position will be responsible for supporting the Director of Research Compliance in the oversight, administration and management of the HCA-HealthONE research compliance program. The Research Compliance Specialist will cultivate and maintain relationships with internal administrators and researchers as well as with external constituencies, agencies and relevant organizations. The Research Compliance Specialist effectively communicates regulations, policies, and associated requirements to IRB members and staff, investigators and research staff, facility administrators and the general HCA-HealthONE research community. The Specialist also works with the IRB Administrator to ensure that the HCA-HealthONE IRB operates within regulatory compliance.
  • Responsible for assisting the Director in the development, implementation, and management of the Research Quality Improvement Program (RQIP) for the protection of human participants in research. RQIP is a training/education program for investigators and research personnel.
  • Develop processes to ensure that new investigators, and investigators without access to professional research support, have ready access to a knowledgeable person to help them navigate the HCA-HealthONE system and comply with federal, state, and institutional requirements.
  • Responsible for performing quality improvement initiatives and audits of IRB approved protocols. Conducts random and for cause audits of investigator sites and monitors the informed consent process.
  • Revises and updates RQIP policies and procedures in response to changes in federal and state regulations. Develops and maintains audit reporting forms and implements revisions as necessary.
  • Responsible for generating written audit notification to investigators, scheduling audits, communicating with research staff of all levels, compiling the final audit report, and presenting audit findings to the Director of Research Compliance, IRB and Chair, and other HCA-HealthONE Administrators as appropriate. Maintains reports, electronic records, investigator correspondence, and findings of audits conducted.
  • Generates correspondence and technical reports for investigators, sponsors, IRB members and other facility personnel on research protocol and compliance issues, as requested.
  • Maintains software system for management of IRB protocol submissions. Assists in the development of the forms utilized in the software system to ensure that all regulatory requirements are satisfied.
  • Responsible for maintaining up-to-date information regarding federal regulations, ethical consideration, and IRB policies related to the use of human participants in research.
  • Assists IRB administrative staff with the day to day processing of electronic study submissions.
  • Assists the Facility Ethics and Compliance Officers with research and compliance related issues.
Other non-manual administrative duties as assigned

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• Location: Denver

• Post ID: 35461498 denver is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017