Clinical Trials Regulatory Specialist II- Division of Infectious Diseases, Hope Clinic

Emory University•Decatur, GA

3d•Onsite

About The Position

The Hope Clinic of the Emory Vaccine Center is an international Center of Excellence in clinical and translational research in infectious diseases vaccines, treatment, and prevention. The mission of the Hope Clinic is to conduct human research studies and clinical trials for infectious diseases of public health importance. The clinical studies encompass vaccines, treatments, prevention, community-based research, and laboratory-based translational human immunology. The Regulatory Specialist II is an intermediate level position supporting regulatory affairs in clinical trial research. Incumbents are responsible for coordinating and supporting regulatory affairs activities for non-interventional and interventional trials for IRB submission. Incumbents may support an extensive and complex portfolio of trials.

Requirements

Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training.
Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
Must obtain all required training courses within one month of hiring date.
Must possess an applicable research certification.

Responsibilities

Supports clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
Documents any exceptions to compliance standards.
Manages new submissions, amendments, safety reports, and continuing review activities.
Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports, deviations, and review of safety reports.
Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
Serves as primary contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
Provides direction and feedback to research team to ensure awareness of business practices and quality standards.
Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
Attends research team meetings to report on regulatory issues.
Responsible for administrative duties corresponding to budgets and contracts.
Performs related responsibilities as required.