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Clinical Research Regulatory Coordinator I
2 months ago
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.
- 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.
- Education: High School diploma or GED required.