Research Regulatory Affairs Specialist

at  Dartmouth Hitchcock Medical Center

Overview
Develops and implements procedures and programs for SYNERGY, Dartmouth’s Clinical and Translational Science Institute (CTSA), to ensure institutional and investigator compliance with federal regulations and other standards guiding Good Clinical Practice (GCP) in human research. Develops, conducts, and oversees the operational functions that support SYNERGY, in particular its research program. Develops and implements educational programs and materials to ensure efficient and compliant processes related to CTSA operations.

Responsibilities

• Serves as the internal subject matter expert on quality and safety matters related to SYNERGY-supported research.
• Performs quality reviews of CTSA-related submissions to NIH’s National Center for Advancing Translational Sciences, submissions to NIH’s eRA Human Subjects System (for prior approval of research with Human Subjects), submissions of proposed live vertebrate animal research for prior approval, and management of the overall quality review and submission process. Quality reviews of protocols involving vertebrate animals will be conducted with guidance from the Institutional Animal Use and Care Committee of Dartmouth College.
• Participates in the NCATS QA/QC discussion forum.
• Reviews all documents posted by NCATS pertaining to human subjects research and review.
• Proactively tracks and manages SYNERGY-related quality and human subjects reporting obligations in collaboration with investigators and appropriate research staff.
• Develops, reviews, and maintains SYNERGY QA/QC-related policies, educational offerings, templates, tools, and guidance documents.
• Curates the QA/QC components of the SYNERGY website.
• Monitors changes to the federal requirements regarding clinical trials, updates SOPs and communicates impact to stakeholders within SYNERGY’s research community.

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.

• Serves as the internal subject matter expert on quality and safety matters related to SYNERGY-supported research.
• Performs quality reviews of CTSA-related submissions to NIH’s National Center for Advancing Translational Sciences, submissions to NIH’s eRA Human Subjects System (for prior approval of research with Human Subjects), submissions of proposed live vertebrate animal research for prior approval, and management of the overall quality review and submission process. Quality reviews of protocols involving vertebrate animals will be conducted with guidance from the Institutional Animal Use and Care Committee of Dartmouth College.
• Participates in the NCATS QA/QC discussion forum.
• Reviews all documents posted by NCATS pertaining to human subjects research and review.
• Proactively tracks and manages SYNERGY-related quality and human subjects reporting obligations in collaboration with investigators and appropriate research staff.
• Develops, reviews, and maintains SYNERGY QA/QC-related policies, educational offerings, templates, tools, and guidance documents.
• Curates the QA/QC components of the SYNERGY website.
• Monitors changes to the federal requirements regarding clinical trials, updates SOPs and communicates impact to stakeholders within SYNERGY’s research community