Position Summary: A brief description of the overall primary duties
Serves as strategic and operational leader in quality & safety for Research Operations across the Dartmouth-Hitchcock system. Provides quality and compliance management programs and oversight to the Research Operations team and other stakeholders.
A listing of the key responsibilities
Leads the Clinical Research Quality and Safety (Q&S) function in the Research Operations Dept. Defines the strategic direction for Clinical Research Quality and Safety and provides functional direction for team.
Establishes and maintains quality management system requirements in accordance with GCP, GLP and Human Subject Protection standard regulations. Responsible for developing and managing ongoing quality measurement and tracking systems and reporting to senior and executive leadership.
Directs Q&S staff under their direction to effectively execute the operating plan, including annual audit plan, approved by senior leadership. Oversees and performs audit processes, including managing audit resources, tracking status of audit findings to closure, and audit record retention
Serves as lead contact for inspections by regulatory agencies and sponsor audits. Develops, plans and leads readiness for inspections and audits at D-H by GCP, GLP and regulatory authorities, clinical investigator sites, and contract organizations.
Establish team/individual goals and expectations for each Q&S staff member to clarify roles and responsibilities supporting all departmental SOPs and corporate policies.
Serves as primary reviewer for quality assurance and compliance sections of contracts and agreements. Develops bid estimates and oversight for regulatory project efforts.
Serves as advisor and consultant to principal investigators, colleagues, and all levels of leadership on the interpretation of regulations and guidance documents to remain compliant..
Provides Quality compliance impact assessments for all change requests; assesses Clinical Research compliance with standard operating procedures, applicable regulations and guidelines and clinical study protocols. Conducts data auditing and review in support of regulatory submissions and periodic safety reports.
Chairs and coordinates quality management review meetings and oversees action items.
Investigates, tracks, and trends all deviations and checks for effectiveness. Identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
Assists with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries
Provides effective oversight of systems (e.g. CTMS, Safety Desk, EMR) cross-functionally in clinical research and development in collaboration with matrixed team members.
Partners with D-H Office of Quality and Safety and other stakeholders to align Research Clinical Quality & Safety to organizational efforts.
Performs other duties as related to providing quality program direction and to the mission, goals, and values of D-H.
Master's degree required, PhD preferred.
Five (5) years of experience in an academic health system or AMC related industry or similar quality roles preferred.
Demonstrated leadership experience required
Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
Demonstrated and thorough understanding of US clinical trials regulations, Good Clinical Practice
Demonstrated ability to identify, evaluate, and communicate risks to trial processes and data with recommendations for resolution.
Demonstrated understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies and clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred.
Experience supporting inspection-readiness activities resulting in successful agency (FDA, etc.) inspections
Ability to analyze challenging and complex research and business issues and opportunities and be proactive in proposing/implementing solutions.
Ability to travel across the D-H system, as needed. Expected travel up to 10%
Demonstrated experience identifying areas for improvement and implementing solutions; ensuring compliance with standards, regulations and company procedures; and administering successful programs within appropriate timelines
Experience conducting training for quality assurance and/or regulatory affairs
Ability to communicate effectively with all levels of management and staff across the D-H system and strong oral and written communications skills required.
Proficiency in Microsoft Word, Outlook, Excel and PowerPoint
Excellent verbal and written communication skills