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Compliance Specialist for Human Subject Research
2 months ago
Job Summary
The Human Research Compliance Specialist provides education and support to researchers and is responsible for performing audits of IRB-approved clinical research protocols across our institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice (GCP) guidelines, as well as with our organization's clinical research policies.
Key Responsibilities
- Performing remote and onsite QA/QI audits of study regulatory and subject files, including providing a written report and assessment of noncompliance, and completing follow-up to ensure corrective actions are implemented and the needs of the study staff are fully addressed.
- Providing education and study management support to the PI and research team.
- Performing proactive education/support (Study Start-Up Assessments, Consultations, Guidance of clinical research protocols before study initiation and as needed as requested by Investigators and MGB leadership.
- Assisting with the development of study management tools and study document templates for use by our research community.
- Assisting with the development of clinical research education, support, and outreach activities across our institutions.
- Providing education to investigators regarding responsibilities of sponsor-investigators related to IND and IDE regulatory requirements, annual reporting to the FDA, and Clinical registration and reporting requirements.
- Representing our team on local/national regulatory work groups and committees as appropriate.
- Remaining current on federal, state, and local laws governing human subject research including attendance at conferences, workshops, seminars, or lectures.
- Utilize 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.
Qualifications
- BS required; Master's degree in related field preferred (., 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
- Extensive knowledge of GCP guidelines, and federal and state regulations governing clinical research
- 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
