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Regulatory Affairs Specialist

Job Attributes

Job Id:

24921

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is currently seeking a Regulatory Affairs Specialist in Bethesda, MD to work with one of the region’s most well-established Research Organization. The Regulatory Affairs Specialist will provide expert regulatory knowledge throughout the life-cycle of a clinical trial to a variety of supporting roles including data management, quality assurance, human safety and clinical operations. 

Responsibilities of the Regulatory Affairs Specialist:

·       Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms (ICF), annual reports, investigational new drug (IND) applications, investigational device exemption (IDE) applications, and summary reports

·       Lead the documentation of investigator and pharmaceutical company meeting minutes throughout interdepartmental collaboration

·       Utilize CTMS (Clinical Trial Management Systems) to successfully organize clinical research data, perform documentation searches and identify supporting information to regulatory documents by citing reports on each finding

·       Maintain the TMF (trial master file) for multiple clinical trials related to ongoing studies

 

Requirements for the Regulatory Affairs Specialist: 

·       1+ years of Clinical Research Experience

·       Knowledge of database management programs, analytical tools, and CTMS

·       Ph.D., PharmD, or M.D. with 1 year of experience or Master’s Degree with 3 years of experience required

 

Compensation for the Regulatory Affairs Specialist:

·       Salary Range:  $65,000 - $80,000 commensurate with experience

·       Benefits Include: Medical, Dental, Vision, 401(k)

 

Please send resumes to Sarah Castle at scastle@pipercompanies.com

 

Keywords:

Good Clinical Practice, GCP, IRB, institutional review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, regulatory affairs, data management, database management programs, analytical tools, CTMS, trial master file, data management, quality assurance, human safety, specialist, clinical operations, management, standard operating procedures, protocols, sop, skillset, leadership, human resources, medical, dental, vision, 401k, 401(k), paid time off, benefits, Clinical Research, Regulatory Affairs, Clinical Research organization, Clinical Research Organization, CRO, research trials, clinical research trials, phd, pharmd, medical doctorate, md, maryland

 

 

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Job Id:

24921

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20817

Security Clearance:

No Clearance

Business Unit:

Piper Companies