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Clinical Research Regulatory Specialist

Job Attributes

Job Id:

34204

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20877

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

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


Responsibilities for the Clinical Research Regulatory Specialist:

·       Responsible for preparing scientific and regulatory documents such as study protocols (SOPs), investigator brochures, ICF/CRF forms, annual reports, IND applications, and summary/annual reports

·       Responsible for analyzing preclinical and clinical research data, perform literature searches and extract information to support regulatory documents and prepare reports on findings

·       Create, distribute and track IND applications and prepared IND sponsors reports

·       Prepare scientific and regulatory documentation for submission to FDA or IRB

·       Prepare regulatory correspondence with PI’s and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates

·       Participate and attend scientific meetings and prepare meeting minutes as necessary for company

·       Maintain database systems such as TMF related to ongoing studies and all regulatory documentation

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


Requirements for the Clinical Research Regulatory Specialist: 

·        2+ 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, EDC, REDCap

·        PharmD, Ph.D. in science-related field preferred, Master’s Degree accepted


Compensation for the Clinical Research Regulatory Specialist:

·       Salary up to $75,000 based on experience

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


Keywords:

regulatory; regulatory affairs; clinical; clinical research, 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, REDcap, EDC


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New Search

Job Id:

34204

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20877

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions