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Clinical Research Regulatory Coordinator I

2 months ago


Birmingham, Alabama, United States UAB Full time
Job Summary

The University of Alabama at Birmingham (UAB) is seeking a highly skilled Clinical Research Regulatory Coordinator I to join our team in the Department of Ped - Hematology/Oncology.

Key Responsibilities
  • Regulatory Documentation Management: Assist in maintaining accurate and up-to-date regulatory documentation, including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
  • IRB Submissions: Collaborate with the team to prepare and submit Institutional Review Board (IRB) submissions, ensuring all relevant documentation is prepared and necessary signatures are obtained to meet study timelines.
  • Informed Consent Documents: Assist in drafting initial informed consent documents, ensuring compliance with regulatory requirements.
  • Regulatory Binders: Prepare and maintain regulatory binders and associated documentation, ensuring accuracy and completeness.
Additional Duties
  • Data Entry: Enter protocol-specific data into required institutional systems (IRAP and OnCore).
  • Delegation of Authority Logs: Maintain accurate Delegation of Authority logs.
  • Training and Documentation: Track and maintain documentation of training, medical licenses, CVs, etc. for key personnel.
  • Investigator Registrations: Update investigator registrations in the CTEP RCR system.
  • Membership Registration: Assist with registration membership for new employees with Children's Oncology Group, CTEP RCR, and other external systems.
  • Document Scanning and Archiving: Scan and archive paper regulatory documents.
  • Other Duties: Perform other duties as assigned by the department.
Requirements
  • Education: High School diploma or GED required.