The Quality Assurance Auditor will conduct routine and focused audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines and research site specific SOPs. The incumbent in this position will advise researchers and appropriate institutional officials of deficiencies and will recommend necessary corrective and preventive actions.Primary Duties and Responsibilities:Conducts routine and focused audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines and research site specific SOPs.Advises researchers and appropriate institutional officials of deficiencies and recommends necessary corrective and preventive actions.Conducts audit follow-up visits to ensure that corrective and preventive actions have been implemented, as necessary. Assists the Executive Director or QA Manager with investigations and/or inquiries as requested by institutional leadership.Prepares reports of audits, investigations/inquiries for internal and/or external use.Assists Executive Director in the preparation and presentation of educational programs to groups and individuals in the University research community.Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research, recommending changes to administrative policies and procedures, as appropriate.Interacts with appropriate persons/agencies (e.g., Offices of Environmental Health and Safety, Human Subjects Research Office, HIPAA Office, Billing Compliance, etc.) to resolve research-related compliance problems.Assists Executive Director in the creation and maintenance of internal policies and SOPs as well as University-wide policies intended to assist University researchers in maintaining compliance with research standards and guidelines.Maintains RCQA related databases and electronic and paper audit files.Other duties as assigned. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Knowledge, Skills, and Abilities:Excellent English (verbal and written) communication skills and interpersonal skills with the ability to deal professionally with all types of information, including that of a confidential nature, required. Excellent organizational skills with strong attention to detail/accuracy and set priorities and effectively perform a variety of tasks simultaneously.Proficiency using Microsoft Office products (Microsoft Word, Excel, PowerPoint, and SharePoint) with excellent data management skills.
Education Requirements (Essential Requirements):Bachelor's Degree in science, health care, or related field; Master’s degree preferred. Any appropriate combination of relevant education and/or work experience may be considered. Work Experience Requirements (Essential Requirements):A minimum of three (3) years of effective work-related research experience, including study coordination, research compliance or auditing experience.Experience in the nursing field is highly desirable. Working knowledge of federal regulations in regards to clinical research and Good Clinical Practice (GCP) is required.
Professional certification in at least one of the following areas: clinical research, research compliance, auditing, GCP-related field is highly preferred.Apply online. Position #P100038110
The University of Miami is home to some of the brightest minds in the world. We are committed to educating and nurturing students, creating knowledge, and providing service to our community and beyond. The University of Miami offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. The University of Miami is an Equal Opportunity/Affirmative Action Employer. Come join us! ]]>