Promotes the ethical conduct of clinical research and ensures compliance with all institutional, federal, state, and local regulations. Assists in the management of the day-to-day operations, personnel and processes of the Office of Research Integrity and Compliance (ORIC). Develops and implements systems for ongoing process improvement and program expansion in a manner that facilitates the ethical conduct of research and ensures compliance with all relevant governmental, Institutional, and other applicable regulations related to the protection and rights of human subjects, HIPAA, conflict of interest management, etc.
Manages activities related to the development, implementation and evaluation of clinical research educational programs and tools consistent with institutional policies, standards of required accrediting agencies (AAHRPP, etc.) and all applicable local and federal regulations (DHHS, FDA, OHRP, ICH-GCP, etc.).
1. Supports the strategic plan for growth and development of the Institution�s research program.
2. Assists in the management of the day-to-day operations, staff, and processes of the Office of Research
Integrity and Compliance (ORIC). Participates in the recruitment, orientation, training, supervision, and
evaluation of clinical research education staff.
3. Conducts periodic needs assessment to establish priorities for clinical research education initiative
throughout the Institution. Develops standards for required clinical research professional competence.
4. Develops, delivers, and/or coordinates mandatory orientation, ongoing training programs, targeted
education, and resources/materials for investigators and staff to enhance the conduct of clinical research,
optimize clinical research operations, and promote compliance with applicable regulations and Institutional
5. Maintains records of training and demonstrated proficiencies. Tracks metrics to evaluate effectiveness and
outcomes of educational programs.
6. Utilizes findings from Post-Approval Monitoring and regulatory audits to identify knowledge gaps and
develops educational programs to address them. Assists investigators and study teams in preparing for
regulatory audits (FDA, etc.).
7. Uses appropriate interpersonal styles to establish effective relationships; interacts with others in a way that
promotes openness, trust, and confidence. Facilitates the adult learning process, creating a climate
conducive to learning and serving as a change agent.
8. Participates in Institutional committees and workgroups which focus on issues relating to research
compliance and/or human subjects protections.
9. Performs job functions adhering to service principles with customer service focus of innovation, service
excellence and teamwork to provide the highest quality care and service to our patients, families, co-workers
10. Other job functions as assigned.
1. Bachelor�s degree in a related field required. Master�s degree preferred.
2. Minimum of 5 years of experience in human subjects research in a hospital, university or other research setting; experience at Lurie Children�s preferred.
3. Demonstrated project leadership skills; capable of performing the majority of Assistant Director responsibilities. A minimum of two years management, teaching or leadership experience required.
4. Professional Certification (Education and/or Research) required.
5. Detailed knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research.
6. Specialized training or experience applying principles of adult education preferred. For example, needs assessment, training material design and development, delivery and evaluation.
7. Excellent interpersonal, communication, and organizational skills to work effectively with different disciplines within clinical research.
8. Exceptional writing skills in order to prepare written and electronic training materials in compliance with Institutional policies and requirements.
9. Sufficient computer proficiency to effectively develop and prepare various educational presentations (Microsoft Office Applications including PowerPoint, Captivate, etc.).
10. Ability to perform multiple tasks with a high level of accuracy and attention to detail.
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