Reporting directly to the Dept Director of Research Operations, provides coordination for the administration, support, quality assurance, and management of research compliance functions for the Office of Clinical Research (OCR). This position participates in the essential aspects of research compliance activities, educates stakeholders on research compliance topics, and supports policy and procedure development.

1. Manages OCR compliance initiatives by:
2. Interpreting and applying federal (US, EMA, or other) regulatory laws and guidance during the monitoring and education of the performance of complex clinical research operations;
3. Interpreting the requirements of ICH GCP, the approved study protocol, and sponsor study related SOPs;
4. Demonstrating an understanding of current events that have influenced guidelines and regulatory processes with regards to FDA regulations and guidelines as well as those on a global scale;
5. Mentoring and educating research teams in the planning and conduct of clinical trials;
6. Providing study and study team preparation assistance for an audit/inspection conducted by a sponsor or regulatory authority;
7. Providing comprehensive regulatory guidance to the DH research community;
8. Overseeing, where appropriate, creation and planning of study-specifc monitoring plans that assure sufficient resources are allocated to ensure timely review of data while maintaining established standards for study participant safety and data integrity;
9. Overseeing, where appropriate, the writing and dissemination of reports (i.e. monitoring / auditing).
10. Assessing new investigator-initiated studies for investigational drug / investigational device exemption applicability.
11. Analyzing, creating, and modifying strategies, policies and procedures to ensure regulatory compliance for studies conducted at DH and implementation of new industry-wide initiatives; and
12. Developing and revising research compliance policies, SOPs, and educational opportunities in response to audit/inspection findings or requests from study teams or
13. Conducts and coordinates human subject research educational initiatives.
14. Initiates and manages compliance initiatives relating to the protection of the rights, safety, welfare of subjects.
15. Serves as OCR's Collaborative Institutional Training Initiative (CITI) Administrator.
16. 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
17. Presents and discusses research compliance related issues and findings with all levels of management and prepares reports and presentations for the OCR.
18. Identifies and facilitates the activities of the key contacts essential to ensuring effective team operations during a clinical
19. Demonstrates an understanding of the cross functional team in developing a communication
20. Performs other duties as assigned

• 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
• Working knowledge of applicable Federal and State of New Hampshire
• Preferred Qualifications include:
• Certification 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.

• None