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Neuroscience Regulatory Affairs Specialist

2 months ago

Edison, New Jersey, United States Hackensack Meridian Health Full time

Become a Part of Hackensack Meridian Health

At Hackensack Meridian Health, our dedicated team members play a vital role in our mission to enhance the health and well-being of our patients. We cultivate a culture of teamwork and collaboration, where employees uplift one another and contribute to the community. Together, we aim to innovate healthcare and lead positive transformations in the industry.

Position: Regulatory Affairs Coordinator

The Regulatory Affairs Coordinator is essential in maintaining adherence to Federal Regulations, Good Clinical Practice (GCP), and institutional guidelines at Hackensack Meridian Health. This role serves as a key link between investigators, various divisions, departments, and regulatory bodies.

Key Responsibilities:

  • Manage and organize regulatory documentation, ensuring all essential papers are filed and signatures obtained.
  • Review Informed Consent Forms to guarantee compliance with GCP standards.
  • Assist in the preparation and submission of documentation related to clinical studies.
  • Ensure timely submission of protocol modifications and other necessary items to the Institutional Review Board (IRB).
  • Facilitate effective communication between the research team and the IRB.
  • Stay informed about GCP and federal regulations relevant to clinical research.
  • Support the development of procedures to ensure regulatory compliance.
  • And additional related tasks...

Qualifications:

  • Bachelor's degree in a science or healthcare-related field, or equivalent experience.
  • Strong attention to detail and a focus on customer service.
  • Excellent communication, organizational, and interpersonal abilities.
  • Capability to work independently or collaboratively in a fast-paced environment.
  • Proficiency in Microsoft Office Suite and other pertinent software applications.

Preferred Qualifications:

  • A minimum of 3 years of relevant experience.
  • Certification in clinical research is advantageous.
  • Familiarity with clinical trials and scientific methodologies.

If you are eager to join a committed team focused on making a significant impact in healthcare, we welcome your application.