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Regulatory Specialist (Clinical Research)

Job Attributes

Job Id:

33411

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Clinical Solutions is seeking motivated candidates for Regulatory Affairs Specialist positions in Montgomery County, Maryland for immediate assistance with an established research firm supporting critical COVID-19 research trials. The Regulatory Affairs Specialist will have direct oversight of regulatory affairs operations and support staff for ongoing COVID-19 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., MD, or PharmD preferred, Master’s Degree accepted


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, institutional 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, COVID-19, COVID, MD, PHD, IND, Investigational New Drug,  infectious disease, vaccine, drug, regulatory submission, electronic submission, medical research data, icf, crf, protocol review, document compiling, timeline tracking, amendment, annual report, continual review

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New Search

Job Id:

33411

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions