This position is responsible for conducting comprehensive research audits and monitoring of clinical trials to ensure faculty, staff, employees and students engaged in research activities are compliant with all aspects of federal, state and local policies and regulations governing clinical research. This position reviews internal regulatory documentation, protocols, amendments, correspondence, case report forms, study data, research billing reports, and adverse event reports. This position also determines overall protocol compliance which includes review of the consent process and eligibility criteria. Medical records, laboratory data, and other source documentation is utilized to examine study data accuracy and completeness. This position prepares audit and monitoring reports based on findings, works with research management to create corrective and preventative action plans, and assists in the development of education and training with respect to the conduct of clinical trials. The Clinical Trials Compliance Analyst is an integral member of the Office of Research. Under the direction of the Director, Research Operations, the Clinical Trials Compliance Analyst promotes and facilitates a culture of compliance through audit activities designed to identify risk and support adherence with Federal, State, and Local Regulations and Guidelines. This includes but is not limited to providing educational programming and tools to facilitate compliant research, conduct quality assurance reviews of data to support reporting and working with the research community to establish standards. The Clinical Trials Compliance Analyst works closely with the Manager of Clinical Research to develop quality/compliance training programs and assists with the delivery of training programs.

• Under the direction of the Director, Research Operations, schedules, prepares and conducts audits and assessments of clinical research studies.
  
  a. Audits and monitors clinical research studies from inception through closure. Interprets regulations and guidance documents governing FDA, OHRP, ICH/GCP and applies the interpretation to daily work.
  b. Provides timely feedback by means of the audit report and ensures timely completion of all audit related activities.
  c. Ensures that all human subject or clinical trial audit reports are accurate and of the highest professional quality.
• Develops, executes and maintains audit schedules according to the needs of the department.
  
  a. Participates in selection of protocols based on risk matrix.
  b. Evaluates the potential risk of compliance deficiencies related to audit outcomes.
• Assists in the development of corrective and preventative action plans and in the review of completed action plans.
  
  a. Works with research management to develop plans based on audit/monitoring findings.
  b. Tracks, collects and reports responses to action plans. Monitors for completion.
• Works closely with the Manager of Clinical Research to develop quality/compliance training programs and assists with the delivery of training programs.
  
• Performs miscellaneous job related duties as requested.
  

To advance hope, healing and the best healthcare for children and their families

Phoenix Children's will be the leading pediatric health system in the Southwest, nationally recognized for exceptional care, innovative research and advanced medical education.

We realize this vision by:

• Offering the most comprehensive care across ages, communities and specialties
• Investing in innovative research, including emerging treatments, tools and technologies
• Advancing education and training to shape the next generation of clinical leaders
• Advocating for the health and well-being of children and families

• We place children and families at the center of all we do
• We deliver exceptional care, every day and in every way
• We collaborate with colleagues, partners and communities to amplify our impact
• We set the standards of pediatric healthcare today, and innovate for the future
• We are accountable for making the highest quality care accessible and affordable