Clinical Trials Regulatory Specialist II - School of Medicine - Infectious Diseases
- Atlanta, GA
- Permanent
- Full-time
- 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.
- 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.