POSITION PURPOSE: Administers a clinical research quality assurance and compliance program as part of the overall Aurora Health Care Compliance Program. Monitors and conducts internal reviews of clinical research quality and protocol adherence for all studies using Aurora facilities or studies overseen by Aurora’s Institutional Review Board (IRB). Collaborates with external auditors to monitor the quality level and protocol adherence of Principal Investigators, the Aurora Clinical Research Department Staff and others conducting human subject research under the oversight of the Aurora IRB. Conducts training by designing and developing instructional materials, training schedules, training modules, and providing training to investigators and their staff for all studies using Aurora facilities or overseen by the Aurora IRB.
Reports to the Director & Deputy Chief Compliance Officer who in turn reports to the Vice President & Chief Compliance/Integrity Officer.
Matrix reporting relationship to the Aurora IRB, its Chair(s) and the Institutional Official.
As part of the Aurora Compliance Program, administers a comprehensive research compliance program, including a quality assurance and protocol adherence function, to ensure that clinical research at Aurora is being conducted in an ethical and safe manner following the applicable protocol, all federal and state laws and regulations, and Aurora-specific policies and procedures, including Aurora’s Institutional Review Board policies and procedures.
Monitors and conducts reviews of clinical research within the appropriate regulatory framework.
Audits individual research trials and research administration functions.
Responds to and investigates complaints related to fraud and abuse, research misconduct and conflicts of interest.
Works collaboratively with staff in the Aurora billing office, IRB office, investigators’ offices, and Division of Research (Clinical Trials Office, Biorepository, Center for Urban Population Health, Biomedical Research, and Nursing Research) to review and assess the quality of records or files, as required by protocol.
Works with internal and external auditors, as required, to regularly monitor appropriateness of billing practices, the quality level and adherence to protocol for research conducted at Aurora facilities.
Routinely works with and reports to the Institutional Review Board in assessing research risks to human subjects and any required corrective action.
Administers baseline knowledge and skill assessment to investigators and research coordinators as directed. Based on the assessment outcomes, develops and/or updates individual curriculum/content/training modules and trains investigators and/or coordinators as needed.
Provides one-on-one or group training and quality improvement strategies to create unique solutions for specific research compliance and quality needs.
Participates in post-competency assessments of Research Coordinators at the completion of the training process and on an as needed basis
Maintains records and prepare documentation of training programs, employee attendance and training program effectiveness.
Staffs the Research Quality & Compliance Committee.
NON-ESSENTIAL FUNCTIONS: The following non-essential job functions are listed to inform you of significant duties and/or skills that form some of the bases for evaluation for merit increases of employees in this position. This does not exclude consideration of applicants who do not possess the ability to perform those skills or duties upon application:
Performs other duties as assigned or as necessity dictates.
Knowledge of clinical research, compliance, nursing, science and health care administration, equivalent to that which would be acquired by completing a regionally accredited bachelor’s degree program.
Knowledge, skills and abilities required to perform this job are typically acquired through a minimum of 5 years experience in Clinical Research with a minimum of two years experience as a clinical research study coordinator and two years experience in quality assurance, either as a study monitor, research educator, and/or research project manager.
Demonstrated knowledge of adult education principles and educational strategies, and quality improvement principles and strategies.
In depth knowledge of Medicare reimbursement regulations, Food and Drug Administration (FDA) and Dept of Health and Human Services (DHHS) regulations and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.
Strong planning, problem-solving and change management skills. Demonstrated leadership skills and abilities, including the ability to lead diverse work teams.
Demonstrated personal traits of a high level of motivation, team orientation, professionalism and trustworthiness, and placing a high value on treating others with dignity and respect.
Strong written and oral communication skills.
Strong skills in personal diplomacy with demonstrated ability to handle sensitive communications with leadership, physicians, management, legal counsel and regulatory agencies.
Demonstrated proficiency in the Microsoft office (Word, Excel, and PowerPoint) suite of applications.
Ability to work independently with good organizational and time management skills, with ability to manage multiple projects and maintain attention to detail.
Knowledge of or experience in research quality and compliance auditing and indicator development.
Must be able to drive to various sites so therefore will be exposed to weather and road conditions.
Operates all equipment necessary to perform the job.