1. Serves as the primary specialist on regulatory affairs processes for clinical research studies. 2. Maintains knowledge of changing regulations and policies governing clinical research. 3. Manages, implements, and evaluates all aspects of regulatory activities including submissions and responses at time of study initiation, execution/maintenance and close out. 4. Creates reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulation, and institutional processes. 5. Ensures study protocol submissions, reviews and reporting requirements are met per ICH/GCP, applicable federal regulations, and institutional and sponsor policies and procedures. 6. Oversees the maintenance of attributable, legible, contemporaneous, original, accurate and complete regulatory documentation to substantiate the essential documents for clinical research trials. 7. Identifies instances of noncompliance and deviations from the protocol and regulatory requirements, evaluates each instance to determine appropriate corrective and preventative action, and compiles information to draft reports to the appropriate parties and committees. 8. Collaborates with Investigators and Regulatory Managers in the preparation and execution of corrective and preventative action plans and ensures implementation and adherence to stated plan. 9. Provides feedback to the Quality Education Unit to contribute to the design of Regulatory Specialists trainings and continuing education. 10. Initiates preparation for interim monitoring visits, internal audits and external audits/inspections for complex clinical research studies. 11. Monitors, interprets, applies, and communicates federal and state regulations, and local policies for new guidance, updates, or policies. 12. Maintains established departmental policies and procedures, objectives, quality assurance programs, safety, and compliance standards. 13. Prepares written documentation as required by the profession and the department; maintains, distributes, analyzes, and projects information for required records, reports and statistics as directed. 14. Performs other duties as assigned.

Preferred Education:  Experience in clinical research in an academic setting preferred.

Preferred Education, Experience and Skills:  Experience in clinical research in an academic setting preferred.

Required Skill/ability 5:  Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.

Posting Position Title:  Regulatory Affairs Specialist 1

Required Skill/ability 3:  Independent worker with ability to multi-task and remain focused in a fast-paced environment. Takes initiative to plan, research and manage complex studies using advanced understanding of clinical research processes across the study lifespan. Works under minimal supervision and understands when to inform others of developments or issues with a specific study.

Work Week:  Standard (M-F equal number of hours per day)

University Job Title:  Regulatory Affairs Specialist 1

Required Skill/ability 1:  Ability to interpret and apply broad knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, institutional and sponsor practices, standards, policies, and procedures at the unit/functional level.

Required Skill/ability 4:  Analytical in nature and assignments involve a significant degree of complexity.  Decisions are guided by various factors including expertise, context, independent judgment, and clear to obscure guidelines and policies and can have an impact to the areas of which they are accountable.

Required Skill/ability 2:  Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information. Advanced oral, and written communication skills and ability to work effectively with a wide variety of external and internal stakeholders.

Bachelor's degree in life sciences or other health related discipline required and a minimum of two (2) years of clinical research support experience.

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