GCLP Quality and Training Coordinator at Stellenbosch University

Role Summary:     

• The GCLP Quality and Training Coordinator is responsible for the management of laboratory and clinical documentation across multiple research studies in CLIME.
• This role ensures that all research activities align with Good Clinical Laboratory Practice (GCLP) standards. The coordinator will oversee the entire document lifecycle - from drafting SOPs to version control - and lead the training initiatives required to ensure field and lab staff remain compliant with study protocols.

Duties/Pligte        

GCLP Documentation and Version Control 

• Document Development: Assisting with compiling and formatting GCLP-compliant documents for both laboratory and clinical field environments.
• Version Oversight: Implementing and maintaining a version control system to ensure only the most current SOPs and forms are in use. 
• Register Management: Maintaining and auditing document registers (e.g. Master Document Index, Equipment Logs, and Staff Signature Logs).
• Archive Management: Managing the secure storage and retrieval of superseded documents to maintain a clear audit trail.  

Training Oversight and Implementation 

• SOP Training Management: Monitoring the training status of all personnel, and ensuring that staff are trained on new or revised SOPs before they are implemented. 
• On-Site Technical Training: Conducting or facilitating in-person training sessions at both the laboratory and clinical field sites to ensure standardised practices. 
• Competency Assessments: Designing and documenting competency assessments to verify that staff can perform technical tasks according to GCLP standards. 

Quality Assurance and Audit Readiness 

• Compliance Monitoring: Performing regular internal "spot checks" of laboratory and field notebooks to ensure contemporaneous and accurate data entry. 
• Corrective Actions: Identifying gaps in compliance and assisting technical leads in developing Corrective and Preventive Actions (CAPAs). 
• Audit Support: Acting as a key liaison during external audits, providing requested documentation and evidence of staff training.

Job Requirements/Pos Vereistes        

• Msc in health science or related field, and/or at least two years work experience as a document manager/clinical research manager/in a quality assurance role.
• The ability to work independently as well as within a project team environment.
• Must be willing to travel to local off-campus clinic sites.
• The ability to communicate openly, clearly and rapidly in English, both verbally and in writing.

Recommendation/Aanbeveling        

• Knowledge of GCLP: A deep understanding of Good Clinical Laboratory Practice (GCLP) and/or Good Clinical Practice (GCP) guidelines. 
• Document Control Expertise: Prior experience in managing complex document filing systems and version control software or manual logs. 
• Technical Writing: The ability to translate complex technical procedures into clear, easy-to-follow Standard Operating Procedures (SOPs). 
• Attention to Detail: An eagle eye for inconsistencies in dates, signatures, and version numbers. 
• Software Proficiency: Advanced skills in Microsoft Word (specifically using styles, headers/footers, and tracking changes) and Excel/Google Sheets for maintaining registers.  

Closing Date  26-May-2026