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

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Location: Kampala, Uganda
Industry: Health Care
Category: Healthcare
Job Type: Full-time
Deadline: Wednesday, March 26, 2025
Base Salary: Not Disclosed

Job Description

The Administrative Assistant, Regulatory Affairs is responsible for providing administrative support in the regulatory affairs department. The role involves effective documentation, compliance monitoring, and follow-up on research studies, ensuring that they comply with ethical and regulatory guidelines.

Key Responsibilities

  1. Administrative Support Services
    • Review and submit packages to ethical and regulatory bodies.
    • Develop and maintain a tracking system to assess submission progress.
    • Create and maintain Standard Operating Procedures (SOPs) for regulatory procedures.
    • Ensure timely renewal of researchers’ practicing licenses and registration certificates.
    • Process payments to regulatory authorities on time.
  2. Research Monitoring Support
    • Ensure study procedures align with protocols and regulatory guidelines.
    • Maintain and store all study source documents.
    • Follow up with teams to confirm adherence to SOPs, protocols, and timelines.
    • Participate in internal and regulatory compliance monitoring as required.
  3. Communication & Capacity Building Support
    • Correspond with ethical and regulatory bodies.
    • Provide training to study staff on regulatory policies and protocols.
  4. Record Keeping
    • Maintain electronic regulatory binders and manage safety reports.
    • Archive completed study documents and ensure proper filing of study files.
    • Track incoming and outgoing documents effectively.
  5. Reporting
    • Provide feedback to the Regulatory Affairs Coordinator about all documentation, submissions, and communications.

Qualifications and Experience

  • Education: A degree in Nursing, Bioethics, or a related field.
  • Experience: At least 2 years of relevant experience in the health research sector.
  • Registration: Must be registered with the relevant professional body.

Work Hours

  • 8-hour shifts.

How to Apply

Interested candidates can apply by clicking here.