Essential Duties: This position reports to the IRB Director and serves as the primary contact for compliance issues involving human subject research.
The position is responsible for the continued development and implementation of a post-IRB approval monitoring program of research studies involving human subjects, as well as other quality improvement activities. As auditor, develops and implements the research audit plan to include the performance of audits of research studies to ensure compliance with federal and state law and regulations as well as institutional standard operating procedures relating to the conduct of research studies.
1.Conducts reviews in response to allegations and findings of noncompliance with federal and state regulations and standard operating procedures as well as sponsor requirements (protocol).
2.Conduct systematic reviews that evaluate researchers' and their study team's compliance with approved protocols.
3.Compile reports on audit/monitoring findings. Recommends corrective actions to researchers and the IRBs as required. Reports the findings when appropriate to IRB leadership and others as appropriate.
4.Receives and handles compliance issues and complaints, and may refer such items when necessary to the appropriate reporting manager.
5.Ensures that the implemented research audit program is appropriate in scope, that identified issues are corrected and that all investigators are educated.
6.Conducts audits to ensure compliance with study or sponsor Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and expectations for data accuracy and completeness. Develops, executes and maintains audit schedules according to the need(s) of the project.
7.Works with the investigator and study team to identify root cause and implements corrective and preventive action plans for identified areas of noncompliance.
8.Assists in the preparation for external audits by regulatory agencies or sponsors. Develops reports for management as requested.
9.Participates in training on the research process. Interprets regulations and guidance documents governing GCP and applies the interpretation to daily work.
10.Reviews adverse events reported by the research teams. Assures that forms are complete and signed by the investigator and that the risk/benefit ratio is not increased. Makes appropriate notifications if risk is increased.
11.Maintains current knowledge of applicable federal and state laws, standard operating procedures, GCP, etc.
12.Assists in the development and implementation of appropriate organizational policies and operating procedures and review of the monthly submission and preparation of IRB agenda (if appropriate).
13.Attends IRB meetings to ensure compliance and to report any pending compliance issues and/or their remedy.
14.Assist with all other duties as needed.
Moderate travel, day and night, (up to 25%) for compliance auditing in the Regions as required, by land and air.
.Bachelor's degree; and/or Master's degree preferred
.A minimum of five (5) years clinical research experience; with two (2) years of IRB, audit and compliance experience.
Trinity Mother Frances Health System