ClinicalTrials.gov Specialist

Job Description:

Job Summary

General Overview

The 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 ClinicalTrials.gov.

The C&E Office is responsible for oversight of ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov. 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 ClinicalTrials.gov compliance.

The ClinicalTrials.gov Compliance Specialist serves as the PRS administrator for ClinicalTrials.gov 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 organization's 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 clinicaltrials.gov regulations and experience in implementing a ClinicalTrials.gov 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 ClinicalTrials.gov.

Principal Duties and Responsibilities

1. Oversee registration, maintenance, and compliance of Clinicaltrials.gov records for Mass General Brigham.
2. Act as an education and compliance expert concerning ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov 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 ClinicalTrials.gov registrations and results reporting at our institutions.
9. Generate and maintain internal policies and SOPs intended to forge institution-wide compliance with ClinicalTrials.gov. This will include the development of recommendations for corrective actions and ensuring appropriate follow-up.
10. Interact with appropriate entities or agencies to resolve ClinicalTrials.gov-related compliance problems.
11. Serve as a Liaison with the NIH ClinicalTrials.gov team to support ClinicalTrials.gov across our organization.
12. As appropriate, participate in the National Clinical Trials Registration Taskforce and other ClinicalTrials.gov 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 ClinicalTrials.gov Ancillary Review Committee lead during the IRB review process.
15. Facilitate ClinicalTrials.gov Awareness associated with federal regulations and any new requirements.
16. Use Mass General Brigham's 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

• Bachelor’s degree in related field required; Master’s degree in related field preferred (e.g., M.Ed., 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 ClinicalTrials.gov oversight/management experience.
• Expert knowledge of related regulations, clinicaltrials.gov 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.