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The Clinical Research Training Specialist supports the Clinical Research Quality Management System by developing, administering, coordinating, and evaluating education and training for investigators, clinical research personnel, and supporting departments. The position develops and administers role-based training requirements, training matrices, competency assessments, research readiness activities, and training documentation to promote compliance with applicable regulatory requirements, institutional policies and procedures and Good Clinical Practice (GCP) standards.
Working closely with the Manager of Clinical Research Quality, department leaders, and organizational learning partners, the specialist supports staff onboarding and ongoing professional development, co-chairs the Quality Management Committee, and translates regulatory and quality requirements into practical guidance and educational resources. The specialist applies principals of adult learning to develop clear, engaging, and effective educational content and learning experiences. The position uses training outcomes, quality findings, and performance metrics to identify learning needs and support continuous improvement across the clinical research enterprise.
The specialist collaborates with organizational learning and training partners to develop interactive and technology enabled educational approaches, as appropriate, to support knowledge retention, competency, and compliant research conduct. JOB DUTIES AND RESPONSIBILITIES:
Supports the clinical research Quality Management System and its compliance with federal, state, and local regulations, Good Clinical Practice (GCP), as well as institutional policies and procedures, including IRB and Network Compliance under the direction of the Manager of Clinical Research Quality.
Co-Chair the departmental Quality Management Committee in collaboration with the Manager of Clinical Research Quality, including planning and facilitating meetings and work sessions; developing agendas; coordinating the review approval, and implementation of policies, Standard Operating Procedures (SOPs), and training initiatives; tracking action items; presenting quality and training metrics; and communicating committee decisions and required follow-up.
Translate complex regulatory requirements into practical operational guidance for research teams including training materials, tools, and educational resources related to clinical research regulations, institutional policies and procedures, and research best practices in alignment with Standard Operating Procedures (SOPs) that are compliant with all applicable regulations, policies, and Good Clinical Practices (GCP).
Develop, implement, and maintain clinical research education and training programs on Good Clinical Practice (GCP), Human Subject Protection requirements, FDA regulations, institutional policies, Standard Operating Procedures (SOPs), and other applicable research requirements.
Administer the clinical research training program and training matrix, including role-specific training, knowledge assessments, and competency checks to verify understanding, identify learning gaps, and promote consistent knowledge and compliant research conduct across study teams, investigators, and supporting departments.
Develop and deliver education on investigator oversight, appropriate delegation of study responsibilities, documentation of delegated duties, and verification that study personnel are qualified and…