Senior Compliance Manager driving compliance risk management in wealth management at TD Bank. Overseeing regulatory compliance and managing a team for branch inspections and investigations.
About the role
- Clinical Trials Regulatory Specialist at Winship Cancer Institute managing regulatory affairs and supporting clinical trials research with a focus on regulatory compliance and communication.
Responsibilities
- Support regulatory affairs in clinical trials research
- Manage study activation process
- Serve as internal project manager for assigned oncology disease group(s)
- Provide timely updates on submissions and regulatory guidance
- Liaison between stakeholders such as sponsors and IRBs
- Independently prepare IRB documents and maintain regulatory files
- Facilitate regulatory oversight of safety reporting
- Prepare and review IND submissions and communicate with the FDA
- Ensure regulatory documentation complies with IRB policies and procedures
- Maintain study regulatory binders and electronic files
- Coordinate protocol activation/maintenance process
- Lead study start-up/maintenance
- Participate in the development of standard operating procedures
- Perform internal audits and quality assurance checks on regulatory documents
- Maintain correspondence and regulatory documentation required by the IRB, FDA, and other institutional and federal oversight committees
Requirements
- Bachelor's degree and five 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 within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.)
Benefits
- Emory is an equal opportunity employer
- Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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