What are the responsibilities and job description for the Regulatory Specialist position at Advance Sourcing Concepts, LLC?
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
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.