Research Regulatory Affairs Specialist at Dartmouth, Apply Now!
Join Dartmouth’s Clinical and Translational Science Institute (SYNERGY) as a Research Regulatory Affairs Specialist and contribute to cutting-edge research that helps advance translational sciences. As a Quality Assurance & Compliance Specialist, you’ll be responsible for ensuring compliance with NIH’s National Center for Advancing Translational Sciences (NCATS) requirements while supporting critical projects, including pilot and trainee research. Your work will directly impact the success of translational research initiatives, focusing on human subjects research and data management security.
About Company:
Dartmouth’s Clinical and Translational Science Institute (known as SYNERGY) is seeking a Quality Assurance & Compliance Specialist (QACS) to join their team. The QACS will play a crucial role in ensuring compliance with NIH’s National Center for Advancing Translational Sciences, working collaboratively with the SYNERGY team to monitor and evaluate research projects and maintain regulatory standards. If you are passionate about research regulatory affairs, this role offers an exciting opportunity to contribute to cutting-edge projects in the medical field.
Responsibilities
Quality Assurance and Regulatory Compliance
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- Serves as the internal subject matter expert on quality, compliance, and regulatory matters related to SYNERGY-supported research projects.
- Performs quality reviews of CTSA-related submissions to NIH NCATS and eRA Commons Human Subjects System (HSS).
- Tracks and manages human subjects reporting obligations in collaboration with investigators and the evaluation team.
Education & Training
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- Provides guidance on NIH and NCATS policies, human subjects research approvals, and compliance obligations.
- Curates and maintains QA/QC components of the SYNERGY website.
- Works in collaboration with SYNERGY leadership and program managers to oversee event and training registration processes within WebCAMP.
Data Monitoring & Reporting
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- Assists in monitoring data quality and compliance of SYNERGY-supported projects.
- Works with SYNERGY evaluation team to track program performance, pilot progress reports, and project outputs.
- Collects mid-year and final progress reports from all awardees.
Qualifications
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- Bachelor’s degree in one of biological sciences, nursing, or related health.
- Minimum of five years of experience supporting clinical trial initiation and conduct, and related regulatory work, or equivalent in education and experience.
- Demonstrated experience working with data collection and a thorough understanding of clinical trials regulatory requirements.
Keywords: Research Regulatory Affairs Specialist, Dartmouth, SYNERGY, Quality Assurance, Compliance, NIH, Clinical Trials, Regulatory Compliance
