Ethics and Regulatory Officer

SUMMARY:
Clinical research relies on accurate documentation, regulatory compliance, and careful coordination to ensure that studies meet the required ethical and regulatory standards.
 
The UCT Lung Institute is seeking a Regulatory Officer to join its Clinical Research Centre (CRC) Unit, supporting regulatory submissions, clinical trial documentation, and compliance with applicable requirements.
 
This role is offered under the University of Cape Town Lung Institute’s own employment terms and conditions, which are separate from UCT conditions of service.

POSITION INFO:
Minimum Requirements:

• Grade 12 / Matric or equivalent qualification
• 3–5 years’ experience in clinical trial regulatory work
• Knowledge of applicable regulatory requirements, including local regulations and industry standards
• Understanding of a regulated clinical trial environment
• Knowledge of and ability to apply GCP, ICH, and applicable regulatory guidelines
• Effective communication and interpersonal skills
• Strong organisational skills, with the ability to prioritise tasks and work independently
• Ability to manage multiple projects simultaneously
• Ability to establish and maintain effective working relationships with colleagues, managers, and clients

• Prepare, review, and coordinate submissions to regulatory authorities and Ethics Committees, including applications, amendments, and progress reports.
• Monitor submission deadlines and assist with reporting adverse events, protocol deviations, and other safety-related matters.
• Maintain accurate Investigator Site Files, regulatory documentation, staff certifications, and informed consent records.
• Update regulatory documentation and study records on the EDGE system.
• Support audits, monitoring visits, regulatory inspections, and staff training.
• Collaborate with investigators, research teams, sponsors, and other stakeholders to maintain regulatory compliance throughout the clinical trial process.

• Fixed Term Contract (60 Months)
• Monday to Friday | 40 hours per week
• Based in Observatory, Cape Town