Provides regulatory expertise, guidance, and administrative support to the Dartmouth-Hitchcock (D-H) Human Research Protection Program (HRPP), and acts as the primary liaison between institutions and external IRBs, managing the administrative and regulatory processes for multi-site research.

Responsible for processing submissions according to the policies and procedures outlined in the D-H Human Research Protection Program (HRPP) Toolkit and serves as a regulatory resource to support IRB reviews. Has the primary responsibility of moving reliance submissions through the office workflow in a timely manner, ensuring that submissions are review-ready prior to reliance, conducting reliance reviews, and generating correspondence after the reliance review process is complete.

• Complies with the D-H HRPP Toolkit, which includes applicable local and federal regulations, rules, guidelines, and ethical principles, and performs duties as specified in the D-H HRPP Toolkit.
• Processes submissions to the IRB Office as assigned, including New Studies, Modifications, Continuing Review, and Reports of New Information. Conducts pre-review to ensure that submissions are review-ready, and communicates review results to investigators and others as needed.
• Escalates matters of concern to the HRPP Director or IRB Manager as appropriate.
• Review, negotiate, and facilitate the execution of reliance/authorization agreements (IAAs):
  • Acts as the primary contact between the institution and the external “Reviewing IRB”.
  • Guides investigators through the submission process for multi-site studies, ensuring proper documentation is filed.
  • Maintain records of reliance and ensure adherence to institutional policies and federal regulations, and collect and convey local site information (e.g., state laws, investigator qualifications) to the external IRB and IRB staff.
• Serves as a resource to researchers and key personnel by providing support for the preparation of research reliance applications, including guidance on applicable regulations, and subsequent submission in the electronic IRB protocol system.
• Maintains D-H Collaborative Institutional Training Initiative (CITI) Training account and provides guidance to researchers and research staff needing assistance with CITI training.
• Assists leaders in researching, developing, and conducting continuing education opportunities for the research community, ensuring continual and up-to-date awareness of the federal regulations that govern human subjects research.
• Monitors, evaluates, and provides feedback to leaders regarding updates/edits needed to the D-H HRPP Toolkit and educational needs (deficiencies) of the research community, and IRB staff.
• Maintains current working knowledge of the regulations for the safety and protection of human subjects in research and stays current on any changes to the regulatory landscape that may affect the research community.
• Performs other duties as required or assigned.

• Bachelor’s degree in a related field or the equivalent in education and experience with a minimum of two (2) years of directly related experience.
• Other combination of education and work experience that provides required knowledge, skills, and abilities deemed necessary for this position allowed.
• Certified IRB Professional (CIP) Certification preferred
• Prior IRB experience preferred
• Expertise in regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA.
• Knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, Outlook; Internet Functions.
• Strong knowledge of protocol processes and approval mechanisms included in ongoing human subject research oversight.
• Strong communication (written and oral), interpersonal, and customer service skills needed to work closely and effectively with researchers, committee members and administrative personnel.
• Detail-oriented with the ability to multi-task and prioritize workload.