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.
- Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
- Excellence in clinical care, service and communication
- Collaborative within our institution and with others who share our mission and goals
- Leadership that set the standard for pediatric health care today and innovations of the future
- Accountability to our patients, community and each other for providing the best in the most cost-effective way.
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.