COMPLIANCE SPECIALIST I Location:
Columbia Full/Part Time:
Full-Time Job ID:
School of Medicine - Office of Medical Research
The primary role of the Quality Assurance Auditor is to confirm School of Medicine investigator compliance with clinical research protocols according to applicable regulations and Good Clinical Practice (GCP), interfacing with Principal Investigators, study team members, and other research personnel in order to carry out this responsibility.
Perform audits as a quality assurance tool that is used to evaluate the effectiveness of monitoring to ensure human subject protection and data integrity within the University of Missouri School of Medicine (SOM).
Review SOM research protocols and operational processes selected at random, upon request, or based on risk assessment, including Industry funded, Federally funded, National Cancer Institute’s National Clinical Trials Network studies, and Investigator Initiated Trials.
Conduct in depth reviews of IRB approved SOM research studies for compliance with federal/state regulations, IHC-GCP, IRB and institutional requirements, and best practices; ensures adherence to the institutional Data and Safety Monitoring Plan (DSMP).
Support SOM study teams with preparing for audits conducted by sponsors, CROs, FDA, and local, state, and federal authorities.
Work with SOM researchers to formulate Corrective and Preventive Action Plans (CAPAs) based on audit findings, deviations, and events; conducts follow up audits to assess if the desired effect/change was achieved.
Prepare audit reports, as well as initial and follow-up communications to sites.
Perform other job-related duties as assigned.
Salary Range: $15.29 - $26.11/hour
University Title: COMPLIANCE SPECIALIST I
Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.
Monday – Friday
8:00 a.m. – 5:00 p.m.
Associate's degree or an equivalent combination of education and experience and at least 1 year of experience from which comparable knowledge and skills can be acquired is necessary.
Two years of human subject clinical research experience is preferred. Certification as a Clinical Research Auditor is preferred.
Application must include CV/Resume and cover letter.
Columbia Missouri Information
Columbia, Mo., is known as an ideal college town, combining small-town comforts, community spirit and low cost of living with big-city culture, activities and resources. Home to nationally renowned public schools and other colleges and educational centers, Columbia is packed with restaurants and entertainment venues and hosts more than a dozen annual cultural festivals.
This position is eligible for University benefits. The University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, and educational fee discounts. For additional information on University benefits, please visit the Faculty & Staff Benefits website at http://www.umsystem.edu/totalrewards/benefits
The University of Missouri is fully committed to achieving the goal of a diverse and inclusive academic community of faculty, staff and students. We seek individuals who are committed to this goal and our core campus values of respect, responsibility, discovery and excellence.
Equal Employment Opportunity
Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, pregnancy, sexual orientation, gender identity, gender expression, age, disability, protected veteran status, or any other status protected by applicable state or federal law. This policy shall not be interpreted in such a manner as to violate the legal rights of religious organizations or the recruiting rights of military organizations associated with the Armed Forces or the Department of Homeland Security of the United States of America. For more information, call the Vice Chancellor of Human Resource Services/Affirmative Action officer at 573-882-4256.
To request ADA accommodations, please call the Disability Inclusion and ADA Compliance Manager at 573-884-7278.
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