Clinical Regulatory Specialist

Piper Clinical Solutions is seeking a motivated Regulatory Affairs Specialist in Bethesda, MD to support an established research firm supporting both commercial and government clients with ongoing clinical research trials.

Responsibilities for the Regulatory Affairs Specialist:

• Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary reports
• Regulatory correspondence with PI’s and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates
• Prepare investigator/pharmaceutical company meeting minutes
• Analyze preclinical/clinical research data, perform literature searches and extract information to support regulatory documents and prepare reports on findings
• Maintain TMF related to ongoing studies and all regulatory documentation
• Update, review, and maintain electronic databases for clinical trials

Requirements for the Regulatory Affairs Specialist: 

• 3+ years of experience managing and submitting regulatory documentation for clinical trials (IRB/GCP/FDA)
• Advanced knowledge of medical terminology
• Working knowledge of database management programs, analytical tools, and CTMS
• Ph.D. in science-related field preferred, Master’s Degree accepted

Compensation for the Regulatory Affairs Specialist:

• Salary up to $100,000 based on experience
• Benefits: Health, Dental, & Vision insurance and 401K