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Job Description
Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
General OverviewThe Human Research Affairs (HRA) Compliance and Education (C&E) Office provides education and support to the Mass General Brigham 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 Mass General Brigham institutions to ensure compliance with relevant federal state and local research regulations and institutional policies.
The C&E Office works closely with clinical research investigators/staff Mass General Brigham Human Research Office (IRB) and Research Compliance offices at Mass General Brigham institutions to ensure optimal conduct of human research within the framework of federal regulations institutional policies and Good Clinical Practice. The C&E Office is committed to promoting an environment in which human subject research will be conducted according to the highest standards Clinical research trials are required to be registered and reported in a publicly-accessible database under Section 801 of the Food and Drug Administration Amendments Act (FDAAA). This database is called .
The C&E Office is responsible for oversight of registration and reporting by Mass General Brigham investigators. This position within the C&E Office will develop and manage a program to ensure adherence to registration and results reporting requirements across Mass General Brigham. This individual will report to and work closely with the Director and Assistant Director of the C&E Office to develop mechanisms that will ensure ethical standards scientific integrity and regulatory compliance with . This will involve working with a variety of tools and databases writing Standard Operating Procedures (SOPs) writing training manuals and communicating with MGB Leadership Principal Investigators (PI) and their research staff to assist with compliance.
The Compliance Specialist serves as the PRS administrator for registration and results reporting for Mass General Brigham Investigators. All activities are conducted under the direction of the Director of the Human Research Affairs Compliance and Education Office. This role will interpret NIH FDA International Committee of Medical Journal Editors (ICMJE) and other federal requirements along with our organizations policies to make independent decisions regarding federal registration and results reporting of clinical trials critical for our compliance with federal law and regulations.
The ideal candidate will have a strong understanding of regulations and experience in implementing a oversight program. The candidate must be able to work collaboratively with stakeholders and subject matter experts to develop high-quality training materials that help ensure compliance with .
Principal Duties and Responsibilities
1. Oversee registration maintenance and compliance of records for Mass General Brigham.
2. Act as an education and compliance expert concerning and the corresponding federal regulations Institutional Review Board (IRB) requirements and our policies and procedures.
3. Develop and coordinate procedures and programs to enhance investigator understanding and compliance with regulations and requirements.
4. Review new protocols and identify which protocols require registration in accordance with FDAAA-801 NIH CMS International Committee of Medical Journal Editors (ICJME) or other policies or regulations.
5. Work jointly with other departments such as IT to enhance existing notification systems and develop reports/metrics/tracking mechanisms to review and monitor records for compliance.
6. Design and implement a communication plan for facilitating researchers compliance with registration and reporting requirements.
7. Notify investigators of non-compliance and raise persistent non-compliance to HRA leadership.
8. Identify gaps in knowledge; develop implement and evaluate educational programs and materials aimed at enhancing the efficiency and compliance of registrations and results reporting at our institutions.
9. Generate and maintain internal policies and SOPs intended to forge institution-wide compliance with . This will include the development of recommendations for corrective actions and ensuring appropriate follow-up.
10. Interact with appropriate entities or agencies to resolve -related compliance problems.
11. Serve as a Liaison with the NIH team to support across our organization
12. As appropriate participate in the National Clinical Trials Registration Taskforce and other conferences meetings and working groups.
13. Provide outstanding customer service to investigators and research teams in response to access requests password reset requests requests for training or assistance in updating records requests for clarification and resolution of problems.
14. Serve as the Ancillary Review Committee lead during the IRB review process.
15. Facilitate Awareness associated with federal regulations and any new requirements.
16. Use Mass General Brighams 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 - Other responsibilities/duties as assigned
Qualifications
- Bachelors degree in related field required; Masters degree in related field preferred (e.g. . MS MSN MSW MPH MPA MSCI);
- Minimum of 3-5 years of proven experience in a research setting with experience in human research protocols and at least 1 to 2 years of direct oversight/management experience.
- Expert knowledge of related regulations registration and results reporting requirements and knowledge of curriculum development Learning Management Systems and adult learning principles.
- Proficient in the full Microsoft Office suite and the ability/affinity to learn new technology applications.
- A combination of education and experience may be substituted for requirements.
Additional Job Details (if applicable)
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
EEO Statement:
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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
