Clinical Regulatory Coordinator

Our client, a leading non-profit healthcare system in New Jersey, is looking to add a Clinical Regulatory Coordinator to support the Quality team by ensuring clinical trials are compliant with business standards and Federal regulations. This individual will act as a POC between team members, investigators, and other vendors.

This Role Offers:

• Competitive wage plus great benefits – medical/dental/vision, 401(k) match, etc.
• A company viewed as leader in healthcare humanitarianism, taking pride in serving those in need.
• Opportunities for top-tier learning programs that inspire, connect, and develop their team.
• Culture of high performance and quality customer care.
• Work to provide the motivation, tools, steps, and community that will produce lasting outcomes.
• High level of involvement in cutting edge clinical research that is set to change the way healthcare providers approach and care for cancer.

Focus:

• Support clinical trials through document submission for regulatory reviews.
• Ensure regulatory files and processes are up to date and submitted for internal audits and site inspections.
• Maintain compliance by reviewing materials provided by sponsors and regulatory agencies.
• Stay abreast with changes to GCP, clinical, and federal requirements along with recommending actions required to maintain compliance.
• Upload all trial paperwork and data collection into electronic databases.
• Follow all Standard Operating Procedures to ensure safety and quality standards.
• Work alongside team of group leaders to create and implement strategy and initiatives for growth and overall operational excellence.

Skill Set:

• 3+ years of regulatory or quality experience in a medical environment.
• Bachelor’s degree in related science field.
• ACRP or SOCRA certification preferred.
• Prior experience with research and clinical trials, as well as knowledge of best practices for HIPAA, consent, GCP, FDA, SOP, safety monitoring, and others.
• Commitment to helping others, while displaying a positive attitude.
• Proficient knowledge of the Google Suite of applications and other data capture systems.