Clin Trials Regulatory Spec.
Emory University 215 reviews - Atlanta, GA

This job posting is no longer available on Emory University. Find similar jobs:Clin Trial Regulatory Specialist jobs - Emory University jobs

Job Title
Clin Trials Regulatory Spec.

Job Requisition ID

School Of Medicine

737500:SOM: Radiation Oncology

Full/Part Time


Minimum Hourly $

Midpoint Hourly $

Minimum Annual $

Midpoint Annual $

Job Description
JOB DESCRIPTION: Supports clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining regulatory compliance throughout the trial's duration for research studies involving human subjects. Establishes and maintains processes and monitors practices to ensure research involving Human subjects complies with regulations. Researches and analyzes problems and takes a leadership role in resolving identified issues. Disseminates information and coordinates or conducts training. Provides direction and feedback to coordinators to ensure quality standards are met and business practices are adhered to. Documents exceptions to compliance standards. Manages new submissions and continuing review activities. Reviews initial submissions to determine review category and action to be taken. Completes submission applications, and other required documentation, prepares protocol specific informed consent forms, HIPAA (Health Insurance Portability and Accountability Act) authorization forms and lay summaries for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities. Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical). Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports. Attends research team meetings to report on regulatory issues. Responsible for administrative duties corresponding to budgets and contracts. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training. Knowledge of federal research regulations and a basic understanding of funding programs and clinical practices. Must be able to pass the Emory IRB's certification exam within three months of being hired.


This position involves:
Not Applicable

About this company
215 reviews