Regulatory Manager

Site: The General Hospital Corporation

At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.

At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.

Reporting to the Director of Quality Assurance, the sIRB Liaison Regulatory Manager (sIRB RM) will be responsible for liaising between the study teams and the Mass General Brigham Human Research Committee/ Institutional Review Board.

Job Summary
Reporting to the Director of Quality Assurance, the sIRB Liaison Regulatory Manager (sIRB RM) will be responsible for liaising between the study teams and the Mass General Brigham Human Research Committee/ Institutional Review Board.

Qualifications

Responsibilities include, but are not limited to the following:

• Act as the key liaison between the sIRB, investigators, relying investigational sites and the Project Management Team.
• Oversee and manage the sIRB submission process according to institutional policies and procedures, applicable federal regulations, and guidelines.
• Review related human research protocols and consent forms for completeness and accuracy and for adherence to institutional policies and procedures, applicable federal regulations, and guidelines governing protection of human subjects in research.
• Review consent forms to ensure that they contain all the basic required elements for informed consent, as required by federal regulation, and work directly with study teams with editing/rewriting for readability at an 8th grade reading level using principles of "plain language."
• Identify requirements for ancillary committee reviews, and other departments, groups, or individuals within each site that share responsibility for human subject protection.
• Keep current on federal, state, local laws and regulations governing human-subject research through attendance at conferences, workshops, seminars, or lectures pertaining to human-subject protection.
• Act as a resource for the study teams regarding federal, state, local laws and regulations governing human-subject research.
• Answer sIRB-related questions, resolve problems and ensure timely and accurate sIRB submissions and approvals to ensure adherence to study timelines.
• Act as a liaison with MGH Legal Counsel, the sIRB and investigational sites to coordinate the finalization and execution of sIRB Reliance Agreements.
• Train and mentor Assistant Regulatory Managers.
• Take on additional tasks and responsibilities, as requested.

Additional Job Details (if applicable)

Skills and Competencies:

• A solid understanding of clinical research methodology, FDA and OHRP regulations as well as ICH GCP is required.
• The ability to multi-task as well as to set and achieve appropriate goals required.
• Excellent verbal and written communication skills.
• Ability to work independently and display initiative.
• Ability to identify problems and develop potential solutions.
• Sound interpersonal skills and the ability to mentor/supervise others.
• Good leadership, presentation, and organizational skills.
• Previous experience with electronic IRB submissions preferred but not required.

Experience (Required):

• A bachelor's degree is required.
• At least three years of experience working in clinical research or similar environment required.

Remote Type

Remote

Work Location

399 Revolution Drive

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

EEO Statement:

The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.