Regulatory Coordinator, Research

ntion to detail, strong organizational skills, and the ability to work independently. If you are passionate about research and making a positive impact on the health and well-being of others, we encourage you to apply for this exciting opportunity.

Ensure compliance with all regulatory requirements: The primary responsibility of the Regulatory Coordinator is to ensure that all research studies conducted by Prisma Health comply with the regulatory requirements set forth by governing bodies.

Monitor and track regulatory documentation: The Regulatory Coordinator will be responsible for monitoring and tracking all regulatory documentation for each research study, including protocols, consent forms, and adverse event reports.

Review and approve study documents: The Regulatory Coordinator will review and approve all study documents to ensure they are in compliance with regulatory requirements and institutional policies.

Facilitate communication with regulatory agencies: The Regulatory Coordinator will serve as the main point of contact for all communication with regulatory agencies, ensuring timely and accurate submission of required documents and reports.

Develop and implement regulatory processes: The Regulatory Coordinator will develop and implement processes and procedures to ensure compliance with regulatory requirements and streamline the regulatory approval process.

Maintain knowledge of relevant regulations: It is the responsibility of the Regulatory Coordinator to stay up-to-date on all relevant regulations and guidelines related to research, including FDA, ICH, and local requirements.

Train and educate staff: The Regulatory Coordinator will be responsible for training and educating research staff on regulatory requirements, policies, and procedures to ensure compliance.

Conduct internal audits: To ensure ongoing compliance, the Regulatory Coordinator will conduct internal audits of research studies and documentation.

Support study start-up and close-out activities: The Regulatory Coordinator will assist with study start-up activities, including preparing and submitting regulatory documentation, and will also assist with study close-out activities, including final regulatory submissions.

Maintain accurate records: The Regulatory Coordinator will maintain accurate and up-to-date records of all regulatory documents, submissions, and communications.

Collaborate with cross-functional teams: The Regulatory Coordinator will work closely with other members of the research team, including investigators, study coordinators, and data managers, to ensure timely and successful completion of research studies.

Adhere to ethical standards: The Regulatory Coordinator

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.