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IRB Administrative Coordinator

Job Attributes

Job Id:

16998

Job Category:

Clinical & Life Sciences

Job Location:

Hyattsville, MD  20782

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is seeking a motivated IRB Administrative Coordinator to support an established and well respected Office of Integrity in the Prince Georges County Area (MD).  The IRB Regulatory Coordinator is responsible for overseeing the regulatory operations of clinical research studies in multiple therapeutic areas.

Responsibilities for the IRB Administrative Coordinator:

  • Assist with functions related to regulatory and ethical review process for the external Institutional Review Board
  • Serve as a resource to the human subjects protection program to questions for triaging of related research study documents
  • Initial review of incoming research submissions for clarity and regulatory compliance
  • Request additional revisions or documents as needed prior to forwarding submissions to regulatory committees
  • File regulatory documents appropriately to maintain accurate and complete records of all IRB activities and maintain databases for tracking studies and IRB submissions
  • Assign regulatory files to internal IRB administrators via document tracking systems
  • Coordinate and track contract review processes with internal and external Grants, Contract and Legal Affairs offices
  • Primary Point of Contact for relying institutions in collaborative research

 

Requirements for the IRB Administrative Coordinator:

  • 3+ years of Administrator  or Assistant experience
  • Experience working with large databases
  • Experience triaging incoming calls and emails from clients and other outside sources
  • Bachelors of Science in related field preffered

Compensation for the IRB Regulatory Coordinator:

  • Benefits: Health, Dental & Vision Insurance, 401K

KEYWORDS:

IACUC, GCP, good clinical practice, Investigational Device Exemptions, IDE, Investigational New Drug, IND, protocols, Food and Drug Administration, FDA, clinical research, clinical trials, research trials, IRB,  institutional review board, CMS, regulatory affairs, regulatory documents, progress reports, final reports, cardiology, cardiovascular, protocol submissions, medical device, human factors studies, behavioral health, 21 CFR 50, 56, and 312; 45 CFR 46, 45 CFR 164,

 

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Job Id:

16998

Job Category:

Clinical & Life Sciences

Job Location:

Hyattsville, MD  20782

Security Clearance:

No Clearance

Business Unit:

Piper Companies