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 & 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. #J-18808-Ljbffr