Regulatory Coordinator, Research

l research studies are conducted ethically and in accordance with regulatory requirements. If you have a keen attention to detail, strong communication skills, and a desire to make a positive impact in the medical field, we want to hear from you!

Oversee and manage the regulatory compliance of all medical research studies conducted at Prisma Health.
Ensure that all research studies are conducted ethically and in accordance with regulatory requirements, including but not limited to FDA regulations and Institutional Review Board (IRB) guidelines.
Develop and maintain a thorough understanding of current regulations and guidelines related to medical research.
Serve as a liaison between the research team, IRB, and other regulatory bodies to ensure timely and accurate submission of all required documents and reports.
Facilitate the preparation and submission of research protocols, informed consent forms, and other necessary documents to regulatory bodies.
Conduct regular audits to ensure compliance with regulatory requirements and identify areas for improvement.
Collaborate with research teams to ensure that all research documents and records are accurate, complete, and up-to-date.
Monitor and track progress of research studies to ensure timely completion of required regulatory activities.
Communicate any changes in regulations or guidelines to research teams and provide guidance for implementation.
Maintain accurate and organized records of all regulatory documents and correspondence.
Train and educate research team members on regulatory requirements and best practices for compliance.
Participate in continuous quality improvement efforts to enhance the regulatory compliance process.
Stay updated on new and emerging regulations and guidelines related to medical research and incorporate them into the compliance process.

Prisma Health is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.