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Clinical Research Regulatory Coordinator

Job Attributes

Job Id:

24774

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19107

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is seeking a motivated Clinical Research Regulatory Coordinator to support a wide range of clinical research studies for a Research Company in Philadelphia, PA.  The Regulatory Coordinator will support multiple therapeutic research fields.

 

Responsibilities for the Clinical Research Regulatory Coordinator

  • Prepare and submit all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by each study protocol (Central and local IRB submissions)
  • Submitting new study, continual review and amendment IRB documents
  • Oversee the day-to-day activities of clinical trials in accordance with Good Clinical Practice (GCP)
  • Train and supervise research staff on the proper procedures and guidelines for conducting clinical trials
  • Maintain regulatory documents in various electronic documentation systems (EDC)
  • Interaction with PI’s and study members to assist with gathering missing regulatory documents and educating research members on any regulatory related questions
  • Tracking IRB submissions through approval process
  • Performs regular quality control assessments to ensure that clinical trial data is collected and stored
  • Organize and maintain regulatory documentation for all patient data
  • Design electronic capture databases and manage all of the data collected

 

Requirements for the Clinical Research Regulatory Coordinator

  • 2+ years of clinical research experience 
  • Experience with Regulatory/Protocol review and submissions (IRB, FDA, GCP)
  • Bachelor’s Degree in Science-related field

 

Compensation for the Clinical Research Regulatory Coordinator

  • Salary up to $75,000 based on meeting of requirements
  • Benefits: Health, Dental & Vision Insurance, 401K

 

Please send all qualified resumes to: dmanley@pipercompanies.com

 

 

Keywords: Clinical Research Coordinator, CRC, subject recruitment, patient recruitment, patient enrollment, EKG, blood sample testing, drug administering, data management, FDA, Food & Drug Administration, clinical research, clinical trials, specimen tissue, clinical documentation, informed consent, IRB, GCP, good clinical practice, SOP’s, cardiovascular, cardiology, pulmonary, Parkinson’s disease, infectious disease, HIV, AIDS, research, study coordination, EPIC, CTMS, ECD, regulatory documents, regulatory submissions, institutional review board, new study, amendments, continual review, regulatory document tracking, submissions

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New Search

Job Id:

24774

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19107

Security Clearance:

No Clearance

Business Unit:

Piper Companies