Regulatory Assistant

Overview

The primary purpose of this position is to provide regulatory document support within the Regulatory staff the Lineberger Clinical Protocol Office. The Regulatory Assistant prepares and ensures the completion of essential documents by clinical research personnel, accurately maintains the regulatory binder for clinical research studies, and communicates regularly with study sponsors, investigators, and LCCC staff regarding the status and completion of essential regulatory documents.

This work is performed in order to comply with federal, state, and local laws, regulations, and guidance applicable to the conduct of oncology clinical research. Regulatory Assistants participate in the collection, compilation, and management of data/information; quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. Regulatory Assistants are expected to use considerable judgment and research skills in performing their work assignments.

Work may include the training of staff and others.

Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

The role involves providing regulatory document support across clinical research activities, maintaining regulatory binders, and coordinating with study sponsors, investigators, and clinic staff to ensure completion of essential regulatory documents. It includes participation in data collection/management, quality assurance and quality control, analysis, generation of new data/information, and editing/formatting of reports. The role requires judgment and research skills and may include training other staff.

• Required Qualifications, Competencies, and
  
  Experience:
  
  Working knowledge of information technology, including Microsoft Outlook, Word, Excel, and PowerPoint; ability to organize, record, and present information; ability to lead exchange of information through dialogue, instruction, and demonstration; ability to develop working knowledge of regulatory requirements and procedures relating to essential document collection for oncology clinical research; ability to communicate professionally both verbally and in writing.
• Preferred Qualifications, Competencies, and
  
  Experience:
  
  Knowledge of regulatory policy relating to clinical research and institutional review boards.
• Minimum
  
  Education and Experience:
  
  Bachelor’s degree or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Special Physical/Mental Requirements:
Position requires sitting for extended periods of time. Ability to move 25 pounds with or without reasonable accommodations. Ability and willingness to push a cart with files between 4-5 buildings.

• Campus Security Authority Responsibilities:
  Not Applicable.
• Position/Schedule Requirements:
  Evening work occasionally, Overtime occasionally, Weekend work occasionally.

Contact Information:
Office of Human Resources at  or employment. The Office of Human Resources will not be able to provide specific updates regarding position or application status.

Equal Opportunity Employer Statement:
The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.

University of North Carolina