Study Coordinator at University of Cape Town

Job description

Job Summary

The Desmond Tutu HIV Centre (DTHC), based in the Faculty of Health Sciences, is committed to the pursuit of excellence in research, treatment, training and prevention of HIV and related infections in Southern Africa. The main purpose of this position is to oversee complete implementation of clinical trial protocols according to Good Clinical Practice.

Requirements:

• Health Sciences or Nursing degree or diploma with applicable registration
• Minimum 2 years’ study coordinating experience

Previous / current training of ICH/GCP guidelines

• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint and Internet)
• Data entry experience on clinical trial data entry systems
• Previous experience in the set up and maintenance of regulatory files
• Strong communications skills with proficiency in English
• Able to multitask and be flexible in terms of role and working hours
• Must be able to work independently and within a team
• Must have planning and organization skills and excellent attention to detail.

Advantageous:

• Xhosa speaking
• Experience with conducting Division of AIDS sponsored clinical trials
• Current GCP certification
• 2 years’ experience in line-management of study staff
• Experience in conducting study procedures (Phlebotomy, ECG’s, etc.)

Responsibilities:

• Establish and coordinate clinical trials from feasibility, through recruitment and enrolment, day-to-day management, data queries, monitoring to archiving.
• Manage all study documentation – including investigator site files and source documents
• Quality Control of study documents – source document and electronic Case Reports Forms (eCRFs)
• Study Procedures – ensure staff are trained appropriately and study protocols are followed
• Coordinate study monitoring visits
• Report on study updates and targets, including participation on conference calls
• Perform all activities according to Good Clinical Practice Standards