Sr. Auditor, Human Subjects Protection Office
Beth Israel Lahey Health · Boston, Massachusetts, US
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. Conduct not-for-cause and for-cause audits o...
Job description
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. Conduct not-for-cause and for-cause audits of approved human subjects' research. As part of the audit process, identify a corrective action plan, and provide any necessary education. The HSPO works collaboratively with the research community, IRB, and HRPP to serve as a resource for conducting human subjects research safety and meeting all regulatory requirements. Serve as a resource for education and monitoring of investigators who hold Investigational New Drug (IND) applications, and Investigational Device Exemptions (IDE). Responsible for overseeing the institutional training for human subjects' research through the development and management of monthly rounds, recorded trainings, and documentation tools. Job Description: Primary Responsibilities: - Conduct not-for-cause and for-cause audits as part of the post approval monitoring program of the Human Research Protection Program (HRPP); Complete a thorough review, report the findings, and develop an appropriate corrective action plan based on the audit findings. - Provide education to the research community on the con...