Clinical Research Quality Assurance Specialist
14 hours ago
We are seeking a highly skilled and experienced Quality Control Officer to join our team at the University of Cape Town Lung Institute. The successful candidate will be responsible for ensuring the highest standards of quality assurance and quality control in our clinical research setting.
Key Responsibilities:- Maintain and prepare Site Investigator Files (ISF) and Trial Master Files (TMF) to ensure compliance with regulatory requirements.
- Perform quality assurance and quality control of Investigator Site Files, including frequent monitoring and general oversight.
- Ensure superior quality assurance and quality control across participant folders by per-visit monitoring and utilization of department trackers.
- Escalate deviations and safety or general concerns timeously as per organisational chart.
- Support the QA department and Manager with administrative tasks as required.
- Assist with preparation and management of monitoring and auditing visits (internal and external) as required.
- Bachelor of Science Degree or Degree in Health Sciences (advantageous) OR Grade 12 / Senior Certificate with exceptional work experience.
- At least 2 - 4 years experience working in a clinical research setting.
- Valid GCP Certificate (compulsory).
- Experience in auditing, monitoring, and maintaining clinical trials according to GCP standards.
- Experience in obtaining and adhering to regulatory requirements (SAHPRA, HREC).
- Excellent work ethic, interpersonal, communication and time management skills.
- 6 to 12-month fixed term contract.
- Working hours - 40 hours per week, Monday to Friday.
- This position will be based in Mowbray, Cape Town.
Please note that only shortlisted candidates will be contacted. If you do not receive a response within 30 days of the closing date, please consider your application unsuccessful.
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