Job opportunities at the MRC

QA/QC Officer

Hiv Prevention Research Unit
1 year contract

Job holder will be jointly managed and report to the investigators and managers. Job holder will conduct internal monitoring to ensure compliance with SA and ICH GCP and HSP requirements. This will include reviewing corrective/preventative actions and providing ongoing feedback on trends and training based on internal review.  Quality assurance activities include working within the framework of approved protocols and study manuals. Officer will review participant binders, informed consent forms and regulatory documentation and ensure there is corrective and preventative action implemented within time frames. All quality assurance and quality control activities will be documented using approved templates and members will address study related queries with PI/Manager and the Study Coordinator to ensure clean and accurate data, while implementing CQMP.

Responsibilities:

• Internal monitoring of clinical trial data using approved protocols and standard operating procedures and  submit corrective action timeously and debrief site on common findings and trends
• Review 100% informed consents forms as per GCP guidelines
• Review implementation of study procedural documentation and logs
• Assist project team before, during and after the external review, to address corrective action of queries and prepare for audits and monitoring
• Assist with training plans and reports when addressing corrective action
• Update and maintain site regulatory and research documentation including local ethics, MCC and sponsor correspondence
• Assist with research administration

Requirements:

• A relevant 3 year degree in Health/Social Science or equivalent qualification
• At least 3 years clinical research experience in a similar position
• Valid GCP and HSP certificate
• Advanced computer literacy viz Ms Excel and MS Word
• Proficiency in written and spoken English
• Work with meticulous attention to detail to ensure  good data quality  
• Effective organizational, communication and interpersonal skills
• The ability to maintain a high degree or professionalism and confidentiality
• The ability to work independently and as part of a team
• The ability to work under pressure and meet deadlines
• Valid code 8 or code 10 drivers licence will be an added advantage

A total cost to company remuneration package of R176 139 – R189 349 per annum will be negotiated in accordance with qualifications and relevant experience.

In accordance with the MRC’s Employment Equity Plan, preference will be given to suitably qualified candidates from the designated groups. For this reason we require Race, Gender and Disability status to be specified. Disabled persons are encouraged to apply.

Closing date: 17 February 2012

Please quote the reference number: “R461” in your subject line of your e-mail, CV and all other communications. If it does not appear in the subject line, then your application/CV will not be considered. Certified copies of your ID and highest formal qualifications must be submitted with this application. Should your application not contain the required information and documents, it will also unfortunately not be considered.

Should no feedback be received within 30 days of the closing date,
kindly consider your application as unsuccessful.
The MRC retains the right not to make an appointment.