Human Research Compliance and Auditing Specialist
Human Research Compliance and Auditing Specialist
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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
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 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.
The Opportunity
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 organizations clinical research policies.
The responsibilities of the Compliance Specialist include but are not limited to:
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. These values guide how we get our work done: Patients Affordability Accountability & Service Commitment Decisiveness Innovation & Thoughtful Risk; and how we treat each other: Integrity & Respect Learning Continuous Improvement & Personal Growth Teamwork & Collaboration.
Other education support or oversight activities as assigned.
Qualifications
- BS required; Masters 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 application
- A combination of education and experience may be substituted for requirements
- Onsite required as needed for audits
Additional Job Details (if applicable)
Working Conditions Required
- M-F Full Time Eastern Business hours required
- Hybrid /onsite required for audits as needed and as planned in Somerville or MGB Local Sites
- Must be open to business needs required for multiple days onsite for FDA needs as needed per month with short notice for audits
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
