Sr. Auditor, Human Subjects Protection Office

Beth Israel Lahey Health•Boston, MA

3d•$75,005 - $172,182•Hybrid

About The Position

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.

Requirements

Bachelor's degree in Nursing or Allied Health Professional required.
Minimum of 3-5 years related work experience required.
Familiarity with medical terminology and a medical center environment.
Knowledge of regulations and guidelines governing human subjects research (e.g. Common Rule, FDA regulations.
Ability to work as a team player with investigators, the HSPO staff, IRB, and other members of the HRPP is crucial.
Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.

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 conduct of human subjects' research; this may be done in the setting of HSPO Clinical Research Team Rounds, study team group meetings, or one-on-one.
Review protocol submissions to the Institutional Review Board (IRB) for consistency related to IND/IDE requirements.
Monitor investigators' adherence to FDA requirements for IND/IDEs, including completion of annual progress reports and submission of safety reports.
Provide a pre-FDA inspection service to meet with the research staff to review regulatory and study files. Provide assistance throughout the inspection process, as needed.
Manage process of providing continuing education credits to nurses and physicians for HSPO education programs.
Provide observation and feedback regarding the informed consent process to investigators and research teams.
Develop written educational materials for PIs and clinical research team members; provide targeted education to members of the research community on how to use these written materials; develop and deliver presentations on IND/IDE requirements and other aspects of required regulatory knowledge to the research community, IRB members, and other Human Research Protection Program (HRPP) staff.
Responsible for monitoring and primary triage of calls into the HSPO Help-Line; when appropriate, address concerns raised by the callers or will obtain background information to discuss with the Director of the HRPP and Principal Investigator.