Demo

Regulatory Specialist

Advance Sourcing Concepts, LLC
Pittsburgh, PA Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 5/4/2025

Advance Sourcing Concepts is looking for a Regulatory Specialist for a position in Pittsburgh PA.

In this position, you will have the opportunity to prepare and coordinate protocol-related documents for clinical trials. You will also serve as a resource to staff and member institutions.

You would have a direct impact on the success of this company by :

  • Preparing documents such as drug applications, protocols, amendments, progress reports, as well as preparing information for submission to applicable agencies and review boards.
  • Researching regulatory issues pertaining to clinical trial protocols, consent forms, progress reports, IRB and drug approval processes to ensure adherence to regulations and guidelines.
  • Serving as a regulatory resource to member institutions, pharmaceutical partners and staff. Provide support to the protocol development team and sites.
  • Developing tools and conducting training presentations to educate staff about issues related to trials.

Skills & Requirements

SKILLS AND REQUIREMENTS

  • Bachelor's degree required, preferably in the sciences. Advanced degree or equivalent experience preferred
  • Minimum of 3 years of regulatory clinical trial experience within the clinical research environment
  • Familiarity with Federal regulations and Good Clinical Practice principles
  • Excellent written and verbal communication skills
  • Able to multi task and meet tight deadlines
  • Strong attention to detail with high level of accuracy
  • Ability to participate as a team member and work independently within established guidelines
  • This position is full-time, Monday-Friday daylight hours. Competitive salary plus an outstanding benefits package. Employee focused company that offers work-life balance and opportunity for long-term professional growth.

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