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IRB Administrator

Job Attributes

Job Id:

16967

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 Administrator to support an established and well respected Office of Integrity in the Montgomery 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 Regulatory Administrator:

  • Assist with functions for IRB related to the regulatory and ethical review process for the external Institutional Review Board
  • Serve as a resource to the human subjects protection program to questions on preparing submissions and compliance with study procedures, relating to IRB reviews
  • Utilize knowledge of federal, state, and local regulations, hospital policies as well as ethical standards to review requests to conduct research under a central IRB
  • Evaluate research submissions for clarity and regulatory compliance and requests additional revisions 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
  • Prepare, negotiate, 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
  • Coordinate all activities related to reciprocity agreements with other institutions and their associated IRBs

Requirements for the IRB Regulatory Administrator:

  • 1+ years of experience in regulatory processes related to clinical research studies 
  • Experience with handling of IRB regulatory protocols and submissions
  • Bachelors of Science in related field

Compensation for the IRB Regulatory Administrator:

  • Salary up to $70,000 based on meeting of requirements
  • Benefits: Health, Dental & Vision Insurance, 401K

 

Please send all qualified resumes to idusci@pipercompanies.com

 

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:

16967

Job Category:

Clinical & Life Sciences

Job Location:

Hyattsville, MD  20782

Security Clearance:

No Clearance

Business Unit:

Piper Companies