- 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.
- 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
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Regulatory Specialist - Pittsburgh, United States - Advance Sourcing Concepts, LLC
Description
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:
SKILLS AND REQUIREMENTS
