Study Coordinator Opportunities

Remuneration:	Market related
Location:	Stellenbosch
Type:	Permanent
Reference:	#TGB12/158/0515

 

Job description

Stellenbosch University

Desmond Tutu TB Centre (DTTC)

Two-year temporary contract (with option for extension)

(Ref.  TGB12/158/0515)

Apply online at www.sun.ac.za/english/careers

 

The paediatric tuberculosis (TB) research group at the Desmond Tutu TB Centre (DTTC), based at the Department of Paediatrics and Child Health in Stellenbosch University’s Faculty of Medicine and Health Sciences, requires the services of a study coordinator to assist with overall implementation of a clinical treatment trial on paediatric TB. Duties:

• Ensuring that general and study-specific regulatory-related processes for the clinical trial comply with standard operating procedures (SOPs) as well as with the requirements of ethics committees and sponsors;
• overseeing trial implementation at the various clinical sites;
• developing and maintaining knowledge of relevant regulations;
• training the study team regarding regulatory requirements and their implementation;
• producing satisfactory regulatory reports and associated documentation in accordance with timelines, SOPs and study-specific requirements;
• completing and presenting protocol-related documentation to the principle investigator for submission to the appropriate regulatory agencies;
• engaging with internal and external stakeholders as appropriate;
• maintaining and updating relevant progress reports regarding amendments, safety events, recruitment status, et cetera for the principle investigator for submission to ethics committees and funders;
• performing quality control and quality assurance, which includes drawing up a quality-management plan for conducting the trial;
• gathering, evaluating, organising, managing and collating of information in a variety of formats including basic analysis and reports;
• assisting with the management of  the research team.

Requirements:

• Experience of clinical research, preferably in paediatric populations, ideally as study coordinator;
• experience performing quality assurance and regulatory functions for clinical trials, preferably on infectious diseases (TB/HIV in particular);
• the ability to work accurately according to procedures, rules and regulations;
• the ability to work independently as a member of an interdisciplinary team;
• sound interpersonal skills;
• good written and verbal communication skills in English;
• the skills to solve problems independently and effectively;
• a goal-oriented disposition;
• computer literacy (MS Word, PowerPoint and Excel);
• a valid driver’s licence and own transport.

 

Recommendations:

• Knowledge of national and international regulatory requirements;
• a nursing or other medical degree, or an equivalent qualification, and registration with a relevant medical authority.

 

Commencement of duties: As soon as possible

Closing date: 30 June 2015         APPLY NOW