Clinical Trial Officer

SUMMARY:
The University of Cape Town Lung Institute (www.lunginstitute.co.za) requires applications for a CLINICAL TRIAL OFFICER*.
 
The Lung Institute, a subsidiary of the University of Cape Town, is a globally recognised medical research facility with a mandate to address priority health issues through Education, Research and Service.
 
The purpose of this position is to ensure the smooth running of clinical trials in the CLII through providing administrative support to the Clinical Trials Unit and research staff working on the studies.

POSITION INFO:
Essential Requirements:

• Tertiary degree or equivalent diploma in a related scientific or clinical field
• Valid GCP qualification
• 1 – 2 years clinical research essential
• Knowledge of TB and scientific vocabulary advantageous
• Computer Literacy (MS Office – Outlook, Word, Excel, PowerPoint including database competency - RAVE, EDC, REDCAP)
• An understanding of publication processes and procedures
• Excellent administrative, organizational and logistical skills
• Excellent report writing skills
• Excellent communication skills (verbal and written)
• Information monitoring and managing
• Research support skills
• Technical knowledge and skill
• Resource management
• Accuracy and attention to detail is essential
• Problem-solving
• Ability to self-motivate and take initiative for tasks
• Excellent interpersonal skills and ability to work well in a multi-disciplinary study team

• Prepare and submit all Ethics Committee documentation and correspondence on behalf of the Principal Investigator.
• Track submission deadlines, follow up on responses, and maintain accurate Investigator Site Files with updated study documents.
• Assist with SOP updates and ensure proper archiving of completed clinical trial files in line with GCP standards.
• Ensure investigators and pharmacist staff have valid malpractice insurance and registration certificates.
• Make sure all staff read and sign SOPs and Work Practice Guidelines.
• Track SOP review dates and ensure new staff complete required training.
• Keep signature and delegation logs updated and assist the team in preparing for new studies.
• Review and update site SOPs to align with operational systems, site processes, and regulatory requirements.
• Develop new SOPs as needed and ensure they comply with ICH GCP, SAGCP, and other guidelines.
• Circulate drafts to stakeholders for input, obtain Principal Investigator approval, and distribute final versions to staff for training and tracking.
• Liaise with Principal Investigators, team managers, and sponsor or CRO representatives.
• Attend unit meetings and perform other research-related duties as assigned.

• Position will be based in Mowbray
• 6 to 12-month Fixed Term Contract
• 40 hours per week, Monday to Friday (Additional Hours as required)