- 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 etc.) 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.
- Use/s the Mass General Brigham values to govern decisions, actions, and behaviors.
- Other education, support, or oversight activities 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
- 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
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Mass General Brigham Somerville, United States RegularHuman Research Compliance and Auditing Specialist Description Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and ...
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Human Research Compliance and Auditing Specialist - Somerville, United States - Partners Healthcare System
Description
Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standardsOur Team
Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quality Assurance/ Quality Improvement (QA/QI) Program within the Office of Human Research Affairs at Mass General Brigham.
We provide education and support to our research community and conduct both routine and for-cause compliance audits of human subject research studies across all our institutions.
We ensure compliance and optimal conduct of human research with relevant federal, state, and local regulations, Good Clinical Practice, and institutional policies.
We collaborate closely with our clinical research investigators and staff, our Institutional Review Board Office (IRB), and Research Compliance offices.
Our team is also responsible for oversight of Clinical registration and reporting by investigators across our system.Role Overview
The Human Research Compliance Specialist (compliance auditor) 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.
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.
