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Regulatory Affairs Coordinator
2 months ago
Become a Vital Part of Hackensack Meridian Health
At Hackensack Meridian Health, our team members are essential to our vision of enhancing 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 revolutionize healthcare and foster positive advancements as pioneers in the industry.
Position: Regulatory Affairs Coordinator
The Regulatory Affairs Coordinator is pivotal in maintaining adherence to Federal Regulations, Good Clinical Practice (GCP), and institutional protocols at Hackensack Meridian Health. This role serves as a key point of contact for investigators, various divisions, departments, and regulatory bodies.
Key Responsibilities:
- Organize and oversee the regulatory documentation, ensuring essential documents are filed and signatures are secured.
- Evaluate and confirm that Informed Consent Forms comply with GCP standards.
- Contribute to the preparation and submission of clinical research documentation.
- Guarantee the prompt submission of protocol modifications and other necessary items to the Institutional Review Board (IRB).
- Facilitate effective communication between the research team and the IRB.
- Remain informed about GCP and federal regulations pertinent to clinical research.
- Assist in the formulation of procedures to ensure regulatory compliance.
- And additional related tasks...
Required Qualifications:
- Bachelor's degree in a science or healthcare-related field or equivalent professional experience.
- Exceptional attention to detail and a strong customer service orientation.
- Outstanding communication, organizational, and interpersonal abilities.
- Capability to work autonomously or collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office Suite and other relevant software applications.
Preferred Qualifications:
- A minimum of 3 years of relevant experience.
- Certification in clinical research.
- Familiarity with clinical trials and scientific methodologies.
If you are eager to join a dedicated team focused on making a significant impact in healthcare, we welcome your interest.
