Clinical Research Compliance and Quality Assurance Specialist
5 days ago
About the Role
The Clinical Research Compliance and Quality Assurance Specialist plays a pivotal role in ensuring that human subject research is conducted according to the highest standards at Mass General Brigham.
Key Responsibilities:
- Performing remote and onsite quality assurance/quality improvement 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 Principal Investigators and research teams.
- Assisting with the development of study management tools and study document templates for use by our research community.
- Representing our team on local/national regulatory work groups and committees as appropriate.
Requirements
- Bachelor's degree required; Master's degree in a related field preferred.
- Minimum of 5-7 years' experience in human subject/clinical research, including at least 1-2 years of experience in clinical trial monitoring/auditing, research compliance, or regulatory oversight/project management of human subject research protocols.
- Extensive knowledge of Good Clinical Practice guidelines and federal/state regulations governing clinical research.
- Proficient in Microsoft Office and the ability/affinity to learn new technology applications.
Estimated Salary Range: $85,000 - $110,000 per year
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