Serves as the primary specialist on regulatory affairs processes for clinical research studies. Maintains knowledge of changing regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department. Manages, implements, and evaluates all aspects of regulatory activities and strategies including submissions and facilitation of responses at time of study initiation, execution/maintenance and close out. Explains regulations, policies and procedures to guide others on regulatory and compliance matters. Creates reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes. Ensures study protocol submissions, reviews and reporting requirements are met per ICH/GCP, applicable federal regulations, and institutional and sponsor policies and procedures. Oversees the maintenance of attributable, legible, contemporaneous, original, accurate and complete regulatory documentation to substantiate the essential documents for clinical research trials.  Identifies instances of noncompliance and deviations from the protocol and regulatory requirements, evaluates each instance to determine appropriate corrective and preventative action, and drafts reports for submission to the appropriate parties and committees. Assesses regulatory activities program wide and identify areas for improvement or that require correction and provides recommendations, as needed. Collaborates with Investigators and Regulatory Managers to prepare and execute corrective and preventative action plans and ensure implementation and adherence to stated plan.  Provides input to the Quality Education Unit to design Regulatory Specialist trainings and continuing education. Initiates preparation for interim monitoring visits, internal audits and external audits/inspections for highly complex clinical research studies. Monitors, interprets, applies, and communicates new and revised federal and state regulations, and local/institutional policies and guidance.  Maintains established departmental policies and procedures, objectives, quality assurance programs, safety, and compliance standards.  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. Assists in mentoring and training of Regulatory Affairs Specialists I. Performs other duties as assigned.

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

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

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

Posting Position Title:  Regulatory Affairs Specialist 2

Required Skill/ability 3:  Independent, organized worker capable of multitasking and remaining focused in a fast-paced environment with competing priorities. Takes initiative to plan, research and manage multiple complex studies using advanced understanding of clinical research processes and procedures across the study lifespan.

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

University Job Title:  Regulatory Affairs Specialist 2

Required Skill/ability 1:  

Interprets and applies advanced 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. Experience interpreting highly complex clinical trial protocols.