Responsibilities:

• Internal monitoring of clinical trial data using approved protocols and standard operating procedures as per the clinical quality management plan 

• Review 100% informed consent forms and locators 

• Submit internal monitoring reports timeously and debrief study investigators and site staff on common findings and trends 

• Assist with preparation for external audits and monitoring 

• Review study related regulatory documentation including local ethics, SAHPRA and sponsor correspondence. 

Core requirements:

• A relevant 3-year degree or Diploma in Health/Social Science or similar relevant qualification or higher

• At least 3 years clinical research experience

• At least 1-2 years’ experience with quality assurance activities in clinical trials

Advantageous:

• Valid code 8 driver’s license

• Valid recent GCP and HSP certificate

• Willingness to work outside normal working hours when required

• Work with meticulous attention to detail to ensure good data quality

• Effective organizational, communication and interpersonal skills

• Excellent computer skills in MS Office packages

• The ability to maintain a high degree of professionalism and confidentiality