Company: Blue Signal Search
Posted on: June 22, 2022
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
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.
- Support clinical trials through document submission for
- 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
- Upload all trial paperwork and data collection into electronic
- 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
- 3+ years of regulatory or quality experience in a medical
- 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
- 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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