Clinical Regulatory Specialist
- Employer
- Piper Companies
- Location
- Bethesda, MD
- Posted
- May 25, 2021
- Ref
- CR
- Discipline
- Clinical, Clinical Research, Clinical Trials, Regulatory, Regulatory Affairs
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
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