| Research Quality & Compliance Specialist -- Milwaukee, WI |
Author: Lori Roesch
Date: 04-07-08 14:07
The Research Subject Protection Program (RSPP) of Aurora Health Care has an opening for a Research Quality & Compliance Specialist.
This position is responsible for administering a clinical research quality compliance and improvement program. Incumbent monitors and conducts internal reviews of clinical research quality and compliance for all studies using Aurora facilities. Collaborates with external auditors to monitor the quality level and compliance performance of the Aurora Clinical Research Department Staff. Responsible for conducting training by designing and developing instruction materials, training schedules, training modules, and providing training to investigators and their staff for all studies using Aurora facilities. Reports to Manager of Research Subject Protection Program who in turn reports to the VP of Operations who is the Institutional Official.
Qualifications (not complete list): Knowledge of clinical research, nursing, science or 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 (2) years experience as a clinical research study coordinator and (2) years experience in quality assurance, either as a study monitor, research educator, and/or research project manager; certified as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) through ACRP or eligible for certification within one year of hire; demonstrated knowledge of adult education principles and educational strategies, and quality improvement principles and strategies is required; in depth knowledge of FDA and DHHS regulations and guidance, as well as International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines is required; demonstrable ability to interact on a professional level with medical staff, community physicians, and representatives of national and pharmaceutical groups is required. Position requires travel among Aurora sites; will be exposed to road and weather conditions.
Interested applicants can apply online at www.AuroraHealthCare.org. For more information about the Research Subject Protection Program, please visit www.aurora.org/irb.
Specific questions regarding this position can be directed to Lori Roesch, CIP, Manager, at 414.219.7740 or e-mail: lori.roesch@aurora.org.
Aurora Health Care, a not-for-profit Wisconsin health care organization, was created around a single idea: There is a better way to provide health care. The 26,000 people of Aurora are working together to give people better access, better service and better results than they can find anywhere else. Our president and CEO is Dr. Nick Turkal. Established in 1984, Aurora has become a nationally recognized leader in efforts to improve the quality of health care. Aurora has sites in more than 90 communities throughout eastern Wisconsin, including 13 hospitals, more than 100 clinics and over 130 community pharmacies. More than 3,400 physicians are affiliated with Aurora Health Care, including more than 700 who make up Aurora Medical Group. Working together, the people of Aurora are determined not only to provide services of the highest quality, but also to make those services affordable and accessible to every person in every community we serve.
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Research Quality & Compliance Specialist -- Milwaukee, WI new |
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Lori Roesch |
04-07-08 14:07 |
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