Reporting directly to the Director of Research Quality & Safety, provides coordination for the administration, support, quality assurance, and management of research compliance functions for Dartmouth Health (DH). This position participates in all essential aspects of research compliance, led by the Office of Research Operations, including quality assurance activities, training and education on research compliance topics, and supports institutional policy and procedure development.

1. Interprets and applies federal (US, EMA, or other) regulatory laws and guidance when conducting quality assurance activities and education of the performance of complex clinical research operations



2. Interprets and applies the requirements of ICH GCP, the approved study protocol, and sponsor study related SOPs.



3. Demonstrates an understanding of current events that have in?uenced guidelines and regulatory processes with regards to FDA regulations and guidelines as well as those on a global scale.



4. Mentors and educates research teams in the planning and conduct of research



5. Provides study and study team preparation assistance for an audit/inspection conducted by a sponsor or regulatory authority.



6. Provides comprehensive regulatory guidance to the DH research community.



7. Develops and/or provide guidance related to corrective action and preventative action (“CAPA”) plans.



8. Analyzes, creates, and modifies strategies, policies and procedures, and quality assurance activities to ensure regulatory compliance for studies conducted at DH and implementation of new initiatives.



9. Develops and revises research related policies, SOPs, and educational opportunities in response to audit/inspection ?ndings, requests from D-H o?ces or departments or the Research Policy Committee.



10. Initiates and manages Research Quality & Safety initiatives relating to research compliance, regulatory affairs, and the protection of the rights, safety, welfare of research participants.



11. Conducts quality assurance activities including auditing, monitoring, and quality assurance assessments.



12. Identifies internal control and research compliance risks to the organization, designs and executes related audits /quality assurance assessments, reports findings and results and recommends interventions to mitigate risks identified through the work.



13. Develops and implements the audit/quality assurance review plans in order to complete review process.



14. Creates study-speci?c monitoring plans that assure su?cient resources are allocated to ensure timely review of data while maintaining established standards for study participant safety and data integrity.



15. Reports observations and corrective action recommendations to investigators and study teams. Provides senior leadership with Executive Summaries as necessary.



16. Manages educational/training initiatives, including the DH CITI program by serving as DH’s Collaborative Institutional Training Initiative (CITI) Administrator.



17. Updates and maintaining research training and education resources on the Research Quality & Safety intranet webpages; develops guidance documents and collaborates with SMEs to deliver current, and accurate resources.



18. Reviews current Human Subjects Research Training requirements per DH policy; reevaluates and revises policy as needed or as determined by Research Policy Committee.



19. Coordinates and conducts Research Quality & Safety human subject research, regulatory affairs and research compliance educational initiatives.



20. Presents and discusses research compliance related issues and ?ndings with all levels of stakeholders, including preparing reports and presentations for the Office of Research Operations, while demonstrating an understanding of the cross functional team in developing a communication plan.



21. Performs other duties as assigned or required.

• Bachelor’s degree in business or healthcare administration, requisite professional training and experience in healthcare/clinical research compliance and quality assurance.



• Minimum of three (3) years of management experience in a clinical research compliance environment; 10 years of research experience



• Knowledge of the code of regulations and GCP for human subjects’



• Strong competency in Microsoft Office programs (Word, Excel, and PowerPoint).



• Ability to assess and resolve unprecedented problems that require research and review of policy, procedures, and



• Effective communication skills; communicates accurate and complete information; maintaining strict confidentiality when necessary.



• Working knowledge of applicable Federal and State of New Hampshire



• Preferred Qualifcations include:



• Certifcation in healthcare compliance or clinical research compliance.



• Clinical research experience.



• Effective organizational skills and a strong attention to detail.



• Effective professional written and oral communications skills.



• Strong interpersonal skills.

• Certified Clinical Research Coordinator (CCRC) or Certified Research Professional (CCRP) preferred.



• 
  Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.