Regulatory Specialist

Regulatory Specialist

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 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.