Research Regulatory Affairs Specialist

Quality Assurance and Regulatory Compliance:

• 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.
• Monitors and ensures NIH Public Access Policy compliance for research publications acknowledging CTSA funding.
• Monitors processes and outcomes to determine the most common errors that occur during the submission of prior approval documents to NCATS. Additionally, develops new procedures and/or modify existing procedures to address these errors in future submissions, ultimately aiming to improve the turnaround time of prior approval and other regulatory submissions to NCATS.
• Assists with updating, compiling, and submitting RPPR materials, including progress reports, evaluation templates, and required documentation for awardees in eRA Commons. Manages overall NCATS Human Subjects Research (HSR) Prior Approval (PA) process for SYNERGY submissions. This position will serve as liaison between NCATS and SYNERGY awardees.
• Reviews documents posted by NCATS regarding human subjects research policies and best practices.
• Assists with training early career investigators on regulatory and administrative processes. This position will provide targeted education on IRB and NCATS submissions that covers study design, regulatory and ethical concerns, informed consent, and data and sample collection and storage.
• Participates in NCATS/CTSA QA/QC groups, forums, and meetings.
• Assists with the development of outcomes dashboards and reports in WebCAMP.
• Monitors pilot project progress, including IRB/regulatory compliance and data safety monitoring.

Tracks publications associated with pilot projects.

Education & Training:

• 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.
• Deploys and manages feedback surveys to assess training and event effectiveness.
• Creates and updates policies and procedures to ensure fulfillment of current and new regulatory obligations, develops and conduct mandated training and education for SYNERGY-affiliated faculty and staff to support adherence.
• Provides training support and guidance for pilot awardees, CTSI affiliated faculty on NCATS and local IRB requirements

Data Monitoring & Reporting:

• 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, and assist in generating data reports for RPPRs and other stakeholder needs
• Collects mid-year and final progress reports from all awardees (e.g., pilots, trailblazers, KL2s) using appropriate forms and required appendices.
• Shepherding protocols through IRB approval processes, and setting up Data Safety & Monitoring Board requirements.

Project & Program Management:

• Coordinates submission reviews for IRB modifications to ensure alignment with NCATS and eRA Commons requirements.
• Supports quality assurance evaluations and contributes to External Advisory Committee meetings and CTSA reporting obligations.
• Engages in NCATS/CTSA QA/QC working groups and forums to ensure alignment with best practices.
• Assists with updating and compiling RPPR preparation materials.
• Assists with the annual required RPPR compilation and submission to eRA Commons.

Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.