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Regulatory Specialist

Company: Blue Signal Search
Location: Teaneck
Posted on: June 22, 2022

Job Description:

Our client, a leading non-profit healthcare system in New Jersey, is looking to add a Regulatory Specialist 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 supply 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.
    • Evaluate materials provided by sponsors and regulatory agencies and ensure compliance.
    • 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 SOPs 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.

Keywords: Blue Signal Search, Paterson , Regulatory Specialist, Other , Teaneck, New Jersey

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