Research Compliance Specialist
Full-time
Others
Lexington - 1800 Nicholas...
8 months ago
Job Description:Baptist Health is looking for a Research Compliance Specialist to join our team in Lexington, KYThe Research Compliance Specialist wil.....
Job Description:
Baptist Health is looking for a Research Compliance Specialist to join our team in Lexington, KY
The Research Compliance Specialist will work autonomously with limited supervision. The Research Compliance Specialist will serve as an expert resource for Baptist Health Research system on regulatory standards and expectations for compliance. This role demonstrates a culture of quality and professionalism. The primary responsibility is to assure Baptist Health Research is compliant with all federal and local laws, regulations, guidelines, and policies to ensure quality research conduct and timely data submission are delivered through a thorough audit process. Also includes the development of institutional guidelines and policies that enable the conduct of research while ensuring compliance with regulatory requirements. Will serve as the primary point contact for FDA audits and other relevant organizational and/or quality audits. This position is responsible for the supervision of audit preparation, implementation and site readiness for external audits and the planning and coordination of internal research compliance audits at all sites associated with the Baptist Health Clinical Research. This position will ensure the facility is always audit ready. Understands and contributes to the health system’s vision, mission, and values in the commitment to patients and families. Acts as a leader in compliance and staff education within Baptist Health Research and impacted departments. Assists the research leadership in the oversight of clinical trial education and compliance areas as they relate to the Baptist Health Research.
Minimum Education, Experience, Training, and Licensures Required:
Bachelor’s degree in clinical research, biology, communications, nursing or related field.
Minimum five years' experience in a research environment and/or significant experience in clinical research and or compliance.
Healthcare Research Compliance (CHRC) certification required or must be obtained within 2 years of hire date.
Current Clinical Research certification recommended.
If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now!
Baptist Health is an Equal Employment Opportunity employer.
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