Sr. Auditor, Human Subjects Protection Office

About the role

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.

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.
• Maintain oversight of 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.
• Support the process of providing continuing education credits to nurses and physicians for HSPO education programs.
• Monitor investigators' compliance with informed consent processes and provide feedback.
• 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.
• Respond to inquiries from the HSPO Help-Line and address concerns raised by callers or obtain necessary background information.

Requirements

• Bachelor's degree in Nursing or Allied Health Profession 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.

Qualifications

• Decision Making: Ability to make decisions that are guided by precedents, policies and objectives.
• Problem Solving: Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.
• Independence of Action: Ability to set goals and determine how to accomplish defined results with some guidelines. Manager/Director provides broad guidance and overall direction.
• Written Communications: Ability to summarize and communicate in English moderately complex information in varied written formats to internal and external customers.
• Oral Communications: Ability to comprehend and communicate complex verbal information in English to medical center staff, patients, families and external customers.
• Knowledge: Ability to demonstrate in-depth knowledge of concepts, practices and policies with the ability to use them in complex varied situations.
• Teamwork: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.
• Customer Service: Ability to provide a high level of customer service and staff training to meet customer service standards and expectations for the assigned unit(s).
• Social/Environmental Requirements: Work requires close attention to task for work to be accurately completed. Intermittent breaks during the work day do not compromise the work. Work routine is fairly consistent, but employee needs to be able to use judgment to respond to events several times a week. No substantial exposure to adverse environmental conditions.
• Physical Requirements: Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally. This job requires constant sitting, Keyboard use, frequent walking.

Benefits

The benefits package includes health insurance, retirement plans, paid time off, and more. Beth Israel Lahey Health is committed to fostering a diverse and inclusive workplace where all employees feel valued and respected. We believe that a healthy work-life balance is essential for employee well-being and productivity. We offer flexible scheduling options and encourage employees to take advantage of their vacation time.

Pay

$79,997.00 USD - $119,995.00 USD. The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.