Research Regulatory Affairs Specialist

Overview

The Quality Assurance & Compliance Specialist (QACS) of Dartmouth’s Clinical and Translational Science Institute (known as SYNERGY) will be responsible for developing and implementing appropriate monitoring and evaluation programs to ensure compliance with the requirements of NIH’s National Center for Advancing Translational Sciences. Specifically, the QACS will work in collaboration with the SYNERGY Administrative Director, project managers, and evaluators to develop, implement and oversee processes and procedures to monitor compliance associated with new pilot projects, trainee projects, and research projects, including IRB requirements and data management security compliance. The QACS will utilize SYNERGY’s centralized data management system (WebCAMP) to track research outputs.

 

The QACS will assist SYNERGY’s leadership comply with the NIH Public Access Policy Compliance process for manuscripts and the Administrative Director with the annual required Research Performance Progress Reporting (RPPR). The QACS will also work with the SYNERGY Evaluation Team in aligning data collection and metrics relevant to quality assurance processes.

Responsibilities

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.

Qualifications

●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 the equivalent in education and experience. ●Demonstrated experience working with data collection and ●A thorough understanding of clinical trials regulatory requirements is essential, in particular related to investigator-initiated research and FDA ●Proficiency with MS Word, Excel and Access is Proficiency with creating, managing and troubleshooting relational databases is desired but on-site training can be done. ●Excellent organizational skills and attention to detail skills Ability to follow multiple, detailed directions. Knowledge of medical terminology required. ●Must have excellent time management skills including the ability to prioritize time-sensitive Must have excellent oral and written communication skills. ●Must be able to understand and discuss specific research-focused material with Investigators and professional research staff.