JOB SUMMARY:

This position resides within the Colorado Multiple Institutional Review Board in the Office of Regulatory Compliance. The Quality Assurance and Education Specialist conducts educationally focused Quality Assurance Reviews, including audits of human research studies conducted at the University and its affiliates. This individual works closely with investigators and their teams to review research records to verify compliance with federal regulations, state laws, and institutional policies. This activity includes identifying opportunities for improvement and providing expert guidance and support, based on regulations and policies, to the research teams for ongoing compliance. The Quality Assurance and Education Specialist writes reports detailing the findings and recommendations and discusses them with investigators and their teams. In this position, there is also the opportunity to provide education and training to researchers on an individual basis or in large group settings.
Key Responsibilities:

50%

• Works extensively with individuals in all areas of the University and UCD affiliates to promote collaboration and to further the University’s research mission.
• Conducts Quality Assurance Reviews and audits of human research studies being done at the University of Colorado Denver | Anschutz Medical Campus and its affiliate institutions as per written policies and procedures to ensure all departments and divisions are in compliance with applicable local and federal laws, regulations, polices, and guidelines.
• Assures adherence to all research standards as set forth by the FDA, OHRP, NIH, ICH-GCP, University of Colorado Denver | Anschutz Medical Campus, and its affiliates, IRBs, and other related regulatory agencies.
• Communicates compliance reviews and audit findings both in person and in writing to the investigator and their research teams.
• Provides guidance documents, templates, and advice on process improvement and best practices as they relate to the conduct of human subject research.

30%

• Under the direction of the COMIRB Assistant Director – Quality Assurance & IRB Reliance, assists in the development of educational tools and activities based on compliance review and audit findings.
• Provides educational training to individual study teams, departments, and to the campus-at-large on topics including, but not limited to, human subjects protection, informed consent, study documentation practices, and FDA-regulated research.

20%

• Serves as an internal resource to address and resolve any questions or issues of a regulatory or quality assurance nature.
• Remains informed of evolving regulatory revisions and guidelines that are relevant and ensures that the information is communicated to appropriate parties.

MINIMUM QUALIFICATIONS:

• A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
• One (1) year of professional-level experience in clinical research.
  Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis.

PREFERRED QUALIFICATIONS:

• Experience with academic center regulatory processes as related to clinical trials.
• Experience conducting audits/quality assurance reviews.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Working knowledge of FDA and OHRP regulations for human subject research, ICH-GCP guidelines, and sponsor operating procedures.
• Knowledge of criteria that meet non-compliance, including serious and/or continuing non-compliance.
• Familiarity with research and regulatory infrastructure and professional staff at the University and our affiliate institutions.
• Demonstrates accuracy in all details, able to record and report effectively.
• Excellent interpersonal and human relations skills.
• Able to work independently.

Please refer the Job description for details