Regulatory Specialist

Location
Bethesda, MD
Salary
Based Upon Experience
Posted
Mar 15, 2021
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 women-owned research firm supporting clinical research trials that are supporting medical breakthroughs.

 

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 all Trial Mastery Files related to current studies

·       Update, review, and maintain electronic databases for clinical trials

 

Requirements for the Regulatory Affairs Specialist: 

·       1+ 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. or Masters (3+ years of experience) in science-related field

 

Compensation for the Regulatory Affairs Specialist:

·       Salary up to $75,000 based on experience

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

 

 

Keywords:

Good Clinical Practice, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf, trial master file, standard operating procedures, protocols, adherence, sop, IRB, case reports, eIRB, e-submissions, emergency submissions, SAE, severe adverse events