Skills:

Company: Piper Clinical Solutions

Location: Washington D.C.

Industry: Life Science

EmploymentType: Full-Time

Salary: 60,000

Description:

Piper Clinical Solutions is looking for a motivated Regulatory Associate to join a well-established health care organization in the Washington D.C. area. The Regulatory Associate will support the cardiovascular team in all aspects of various clinical research projects.

 

Responsibilities for the Regulatory Associate:

·          Prepare standard documentation supporting regulatory filings

·          Distribute regulatory documentation among teams to ensure timely regulatory submittals

·          Submit appropriate documentation to the FDA

·          Develop and maintain Standard Operating Procedures (SOP's)

·          Ensure studies are compliant with various agency standards and regulations

·          Communication with sites to ensure submissions to the IRB are timely and accurate

 

Requirements for the Regulatory Associate:

·        2+ years of experience in regulatory affairs

·        Experience supporting a high volume of submissions and projects

·        Experience handling clinical research regulatory documentation (IRB, GCP, FDA)

·        B.A./B.S. degree

 

 Compensation for the Regulatory Associate:

·        Salary Range: $50,000-60,000 based on experience 

·        Benefits: Health, Dental, & Vision insurance and 401K

Please send all qualified resumes to Michael Epstein: mepstein@pipercompanies.com