Major Responsibilities:Works with the Research Compliance Analyst II in providing review of post approval materials (modifications, significant new information, unanticipated problems, noncompliance reports). Works with IRB coordinator to route items to convened board as needed. Writes IRB meeting minutes of convened board post approval actions.Assists the Research Compliance Analyst II and Director in conducting Human Subject Research (HSR) determinations and evaluations of institutional engagement in Human Subject Research.Serves as the point of contact and resource for submissions ceded to external IRBs. Reviews 'Requests to Cede IRB Oversight'. Works with Director to execute institutional reliance agreements. Establishes institutional worksheets and consent/HIPAA boilerplate language used in studies ceded to external IRBs.Coordinates the researcher Conflict of Interest process for the RSPP. Conducts Significant Interest relatedness reviews as needed.Assists the Research Compliance Analyst II in the development and presentation of RSPP educational materials to research community and IRB members.Assists in conducting the gap analysis evaluation of RSPP SOPs/policies versus accreditation standards. Assists in creation of accrediting body (AAHRPP) application process and development of education materials for site visits.Develops and maintains electronic communication tools to include email blasts/list serve and websites for research community and IRB members.Serves as a resource for research community and IRB members in the use of the electronic submission system. Develops training modules and FAQs as needed.Serves as a resource for the research community and IRB members on the HSR training program (CITI).Coordinates RSPP Quality Programs and reviews activities as needed.
Licensure, Registration, and/or Certification Required:None Required.
Education Required:High School Graduate.
Experience Required:Typically requires 2 years of experience in human subject research environment or IRB office.
Knowledge, Skills & Abilities Required:Working knowledge of Belmont Report, Declaration of Helsinki, and the Nuremburg Code as they apply to the ethical conduct of research involving human subjects.Working knowledge of the basic considerations of engagement in human subject research and regulations governing human subject research, HIPAA regulations, and IRB processes/actions.Ability to transfer regulatory knowledge into informational and practical applications.Ability to work independently or as a team.Ability to handle complex problems with flexibility, creativity, and patience.Ability to effectively communicate with all professional levels. Must have good customer service aptitude.Must be proficient with word processing, excel spreadsheet, email, database and presentation software programs.Knowledge of medical and scientific terminology.Ability to travel to Advocate Aurora Health research sites.
Physical Requirements and Working Conditions:Ability to sit, walk, stand, bend and lift frequently throughout the workday. Occasionally lifts items weighing up to 20 lbs.Must have functional speech, vision, and hearing.Exposed to normal office environment.Operates all equipment necessary to perform the job. Position will require travel among Aurora sites and therefore there is exposure to road and weather conditions.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.