Director, Regulatory and Quality Assurance

2 weeks ago

Chicago, United States Nrharural Full time

General Summary of Position Responsibility: The Director, Regulatory & Quality Assurance, assumes a critical role in the research enterprise at Stanley Manne Children’s Research Institute by ensuring investigators and study teams have the knowledge and tools to conduct research in compliance with federal and state regulations, promoting an environment in which research is conducted according to the highest standards, and facilitating high-quality, uniform education for the clinical research community. The Director is responsible for continuously assessing the research community’s needs and developing new initiatives in response to them. The Director is responsible for creating an environment that promotes and fosters the highest legal, ethical, and operational standards for the research community. .

Essential Job Functions: Work with the Research Compliance Officer and other leaders to develop and implement policies in response to clinical research operations improvement needs as related to federal, state, or local regulations or initiatives.

Conduct on-site research study/investigator audits (routine/not for cause for compliance with International Conference on Harmonization and Good Clinical Practice (ICH-GCP), Food and Drug Administration (FDA) policy/guidance regulation. As requested, collaborate with the HRPP on directed/for cause audits.

Analyze and present results of the on-site study/investigator audits. Monitor trends in noncompliance with GCP standards and identify opportunities for improvement in oversight of clinical research operations.

Review, investigate and create reports with recommendations relevant to determinations and Corrective and Preventative Action (CAPA) for incidents that occur in research and research operations, including but not limited to unanticipated problems involving risks to subjects or others, unanticipated adverse device effects, noncompliance, and participant complaints.

Draft, track, and manage required reports to federal funding agencies associated with the conduct of research.

Build curriculum for investigators and study teams in coordination with the Office of Research Development on best practices in study management. The curriculum should be continuously updated and informed by the findings and observations from the on-site study/investigator audits.

Collaborate with leadership of the Human Research Protection Program (HRPP), the Office of Clinical and Community Trials (OCCT), and other areas to identify opportunities that would benefit from compliance and educational support and other QI initiatives.

Provide guidance to Clinical Research Leadership and the IRB on applicability of regulatory requirements and pathways for research protocols (e.g., whether a particular study needs an IND/IDE, if a study can be considered exempt from investigational regulations, etc.).

Provide support and be an acting resource to all investigators and study teams in the event of external audits and inspections (e.g., FDA) and in addressing specific issues of noncompliance. Provide business development advice to Investigators and the organization, if needed.

Collaboratively interact with clinicians, investigators, staff, and all levels of management, including senior leadership.

Promote and encourage a high-quality customer service experience.

Ongoing oversight and assessment of regulatory and educational activities for the research community, including: On-site research study/investigator audits (routine/not for cause for compliance ICH-GCP, FDA policy / guidance / regulation. As requested, collaborates with the HRPP on directed/ for cause audits).

Assistance with study startup, conduct, and closeout, including Regulatory binder and electronic Regulatory binder.

Hospital-wide clinical research education program.

Support for FDA IND/IDE Sponsor Investigators including application consultation and education.

Support for n-of-1 and Expanded Access Program (EAP) clinical trials, including operational management.

Oversight of FDA inspections of clinical research studies for investigator/sponsor responsibilities.

ClinicalTrials.gov registration and reporting program.

Establishment and management of Data Safety Monitoring activities, including related committee activity.

Coordinate and support monitoring activities and centralized documentation of oversight activities within other areas of the Research program, including animal and basic sciences.

Manage and initiate other institutional initiatives and duties as assigned.

Knowledge, Skills, and Abilities: Bachelor’s degree required. Master’s degree preferred.

Minimum of 8 years of experience in clinical research support and oversight.

Relevant federal human research regulations experience.

Experience supporting FDA-regulated drugs and/or devices and previous experience interacting with FDA.

Ability to analyze complex regulatory pathways and to devise regulatory strategies for complex medical products.

Experience growing compliance programs or leading and supporting organizational change.

Significant experience in managing a diverse staff.

Interpersonal skills necessary to interact effectively with physicians, principal investigators, medical center personnel, and external funding agencies and to maintain a variety of internal and external contacts.

Must possess strong written and verbal communication skills and be detailed oriented.

Demonstrated ability to work constructively, collaboratively, and diplomatically with many diverse individuals and groups within and outside the organization.

Ability to communicate with all levels of faculty and staff within the institution in an accurate, helpful, and customer service-oriented manner.

Ability to be flexible, effectively prioritize tasks, exercise good judgement, and be decisive under pressure, including in stressful situations and under deadlines.

Excellent command of the English language. Knowledge of medical terminology is required.

Organizational skills, including the ability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations. Ability to work effectively under pressures of various deadlines.

Candidate must be able to make independent decisions and function independently with minimal supervision. Candidate should be able to function with a high level of discretion and confidentiality.

Must maintain current knowledge of federal, state, and local regulations and standards pertaining to the conduct of research and research compliance, such as GCP, DHHS, OHRP, FDA, OLAW, and USDA.

Must have working knowledge of Windows applications (e.g., Excel, MS-Office/Word, ACCESS).

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