The Mass General Brigham (MGB) Human Research Affairs Compliance and Education Office was established in June 1999 as the Human Research Quality Improvement Program within MGB Human Research Affairs which oversees human research at all MGB institutions. The Human Research Compliance and Education Office (C&E) provides education and support to the MGB research community. In addition, the C&E Office is required and has the authority to conduct compliance audits (routine and for cause) of human subject research studies at MGB institutions to ensure compliance with relevant federal, state, and local regulations and institutional policies. The C&E Office is also responsible for oversight of Clinical Trials.gov registration and reporting by MGB investigators. The C&E Office is committed to promoting an environment in which human subject research will be conducted according to the highest standards. The C&E Office works closely with clinical research investigators/staff, MGB Human Research Office (IRB), and Research Compliance offices at MGB institutions to ensure optimal conduct of human research within the framework of federal regulations, institutional policies, and Good Clinical Practice.
The Human Research Compliance Specialist provides education and support to researchers and conducts compliance audits under the direction of the Director of the Human Research Affairs Compliance and Education Office.
Use/s the Mass General Brigham values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration
Performs regulatory compliance audits of IRB-approved clinical research protocols at MGB institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice guidelines (GCP), as well as with MGB clinical research policies. The compliance audit process includes but is not limited to:
Communicating with Principal Investigator (PI) and designated study staff,
Performing remote and onsite review of study regulatory and subject files,
Providing education and study management support to the PI and research team,
Providing a written report and assessment of noncompliance,
Completing follow up to ensure corrective actions are implemented and the needs of the study staff are fully addressed.
Perform Study Start Up Assessments of clinical research protocols prior to study initiation
Perform audits of MGB IRB to ensure compliance with applicable regulations, institutional policies, and Good Clinical Practice guidelines
Conduct consultations pre-audit and as needed/requested with investigators and study staff on human subject research
Provide human research education at MGB institutions to large and small groups as assigned
Assist with the development of study management tools and study document templates for use by the MGB research community
Assist with development of clinical research education, support, and outreach activities at MGB institutions
Provide guidance and education to investigators and clinical research staff regarding relevant federal and state regulations as well as institutional policies and procedures
Provide education to investigators regarding:
Clinical Trials.gov registration and reporting requirements
Responsibilities of sponsor-investigators related to IND and IDE regulatory requirements and annual reporting to the FDA
Provide education, support/guidance, and resources to MGB research teams regarding all aspects of human subject research
Represent the Compliance and Education Office on local/national regulatory work groups and committees as appropriate
Provide guidance and education to MGB investigators and research teams on use of research-related electronic platforms used at MGB
Remain current on federal, state, and local laws governing human subject research including attendance at conferences, workshops, seminars, or lectures pertaining to human subject research
Other education, support, or oversight activities as assigned
Other duties as assigned
BS required; Master’s degree in related field preferred (e.g., MS, MSN, MSW, MPH, MPA, MSCI)
Minimum of 5-7 years’ experience in human subject/clinical research including at least 1-2 years of experience clinical trial monitoring/auditing, research compliance, or regulatory oversight/project management of human subject research protocols including Clinical Trials.gov
Extensive knowledge of federal and state regulations governing clinical research, and GCP guidelines;
Proficient in the full suite of Microsoft Office and the ability/affinity to learn new technology applications
A combination of education and experience may be substituted for requirements
As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.We’re focused on a people-first culture for our system’s patients and our professional family. That’s why we provide our employees with more ways to achieve their potential. Mass General Brigham is committed to aligning our employees’ personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development—and we recognize success at every step.Our employees use the Mass General Brigham values to govern decisions, actions and behaviors.... These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.