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.
Bachelor’s Degree in a related field (Required)
Masters Degree in a related field (Preferred)
Five (5) or more years of clinical research experience (Required)
Two (2) or more years of clinical trials auditing/monitoring experience (Required)
GCP and human subjects protection training (Required)
Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines (Required)
Knowledge of IRB and federal regulations as they pertain to human subject research and the ability to interpret and apply laws and regulations to ensure the overall protection of human participants (Required)
Project management skills, including the ability to identify needs, develop action plans, and manage projects to completion. Ability to multitask and to work efficiently and independently (Required)
Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care (Required)