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Compliance Quality Assurance Specialist


Posted: 11/13/2018
Job Status: Full Time
Job Reference #: 183367
Keywords: database

Job Description

POSITION INFORMATION: Reports to the Director,Office of Compliance.  Assistswith the development, implementation, and management of the Quality ImprovementProgram for assigned programs or areas. Communicates policies and procedures, trains personnel, and evaluatesall aspects of assigned program(s); prepares written reports includingrecommendations, as required. 



  1. Works closely with the Director of Compliance to ensurethat the components of the OU HSC HRPP/IRB are compliant with all aspects offederal, state and local regulations as well as institutional, accreditationand other policies and procedures that govern human research. 
  2. Performs post-approval monitoring of research approvedby OU HSC IRB.  Conducts both routine andfor-cause audits to ensure compliance with the approved protocols and allapplicable aspects of human research protections.  Performs quality improvement initiatives andclinical study evaluations of approved protocols.  Conducts evaluations of clinical and/orresearch protocols and associated records for adherence to federal and stateregulations, program and institutional guidelines governing research.  Reviews research and medical records on sitefor evaluation data. Conducts evaluations of investigator sites on acase-by-case basis and performs queries of program database for randomselection of protocols identified for Quality Improvement evaluations.
  3. Assists with the development of curriculum for training researchers, researchassistants, graduate students, post-docs, and others in the program.  Records and tracks educational activities andensures that educational certifications have been met prior to initiation ofresearch. Develops and implements educational materials and providesinstruction on all aspects of conducting research within assigned program.
  4. Maintains reports, electronic records, and findings ofevaluations conducted. Maintains correspondence to investigator andinvestigator responses.
  5. Develops reports of results of records evaluation forpresentation to the appropriate Director(s). Prepares written reports and presents evaluation findings to theExecutive Committee on a case by case basis.  Generates writtenevaluation notification to investigators and communicates with research staffof all levels.
  6. Maintains updated Quality Improvement policies andprocedures in line with current federal and state legislation and institutionalregulations and policies.
  7. Performs various other duties as assigned by theDirector of Compliance to successfully fulfill the function of theposition. 



Education:  Bachelor's Degree in related field


Experience: 12months experience with federal regulations in a clinical and/or regulatoryenvironment.


Equivalent/Substitution:  Will accept 48 months related experience in lieu of theBachelor's Degree for a total of 60 months related experience. 


Skills:  Knowledge of federal regulations governing clinical researchand experience in a clinical/regulatory environment .

Department Preferences: Experience working within a University setting.