Administrative Assistant, Regulatory Affairs at Baylor College of Medicine Children’s Foundation

Provides regulatory affairs support with administrative maintenance and follow-up. The job holder is responsible for effective documentation and compliance monitoring of research studies.

Overall Responsibilities
• Administrative Support Services
• Review submission packages and facilitate submission to ethical and regulatory bodies.
• Develop and maintain tracking system to assess progress on submission.
• Develop Standard Operating Procedures that streamline regulatory procedures.
• Arrange the timely renewal of practicing license and registration certificates of researchers.
• Prepare payments to regulatory authorities in a timely manner.
• Research Monitoring Support
• Check that all study procedures and reporting are conducted in accordance to the site, protocol, and regulatory guidelines.
• Maintain and store all source documents for the study.
• Followup teams to confirm that SOP, protocol, and regulatory mandated timelines and IRB reviews are followed.
• Participate in internal, regulatory, and compliance monitoring as required.
• Communication &Capacity Building Support
• Correspond with Ethical and Regulatory bodies.
• Provide training for regulatory and protocol related policies to study staff.
• Record Keeping
• The job holder creates and maintains electronic regulatory binders, logging of safety reports, scanning and uploading regulatory documents as well as processing minor amendments.
• Maintain up-to-date regulatory binders.
• Ensure proper filing of study documents in properly labelled files while tracking documents coming and leaving the office.
• Archiving of completed studies documents.
• Reporting
• Provide feedback to regulatory affairs coordinator, about all documentation, submissions and communications.

Required Qualification, Experience and Competencies:
• A Degree in Nursing, Bioethics or related field
• Registered with the relevant professional body is key
• 2 Years Relevant Experience

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