OrganisationMedecins Sans Frontieres
LocationKhayelitsha, Cape Town , South Africa
South Africa’s health, humanitarian, and socio-economic problems are characterized by extreme inequalities and uneven distribution of resources. Thirteen per cent of the population lives in “first world” conditions, while nearly 50% live in poverty, characterised by poor housing and limited access to basic services, such as water, sanitation, electricity and primary education. Worldwide, South Africa has the highest number of people living with HIV – at 6.8 million – and the largest antiretroviral therapy programme, the highest incidence of tuberculosis – with an increasing drug resistant TB epidemic.
The treatment outcomes for multidrug-resistant (MDR)-TB are poor, with treatment success rates of 50%. This is largely due to the use of less effective and more toxic second line antituberculosis agents. Recently, highly effective new and repurposed drugs have become available to treat TB. These provide an opportunity to design novel regimens for drug-resistant TB that are shorter and injection-free. Although a number of these drugs are available to selected patients through clinical access programmes and advocacy, they require a stronger evidence base to enter guidelines as first line therapy for drug-resistant TB, in order to broaden access.
The endTB project aims to find shorter, less toxic and more effective treatments for MDR-TB through access to new drugs, a clinical trial, and advocacy at national and global levels. Covering 15 countries, the project is a partnership between Partners In Health, Médecins Sans Frontières (MSF), Interactive Research & Development, and financial partner UNITAID. MSF South Africa has recently taken on the endTB clinical trial as a project at its Khayelitsha site.
The endTB clinical trial is a phase III randomized controlled trial of five novel, all oral, 9-month regimens compared to the current standard of care for MDR-TB. The trial will combine the first new TB drugs developed in almost 50 years — bedaquiline and delamanid —with other oral TB drugs such as clofazimine, linezolid, fluoroquinolones and pyrazinamide into experimental new treatments. The clinical trial is expected to enroll 750 patients across six countries: Georgia, Kazakhstan, Kyrgyzstan, Lesotho, Peru and South Africa. These are all countries with significant TB burdens, where MSF or Partners in Health support local MDR-TB treatment activities. At the South African site, the trial will take place at four MSF-supported clinics in Khayelitsha, where it aims to enroll 100 participants with a follow up period of two years. A team of trial staff will be employed specifically for the endTB project.
Purpose of the post
A pharmacy assistant will be employed to join the endTB trial team in Khayelitsha. The purpose of the post is to provide support to the endTB trial pharmacist and assist with management of the trial pharmacy, in accordance with South African Pharmacy Council (SAPC), Medicines Control Council (MCC), Good Clinical Practice (GCP), and Good Pharmacy Practice (GPP) guidelines.
Responsibilities of the endTB Research Pharmacy Assistant:
Pharmacy regulatory compliance
- Ensure that all study drugs are stored according to protocol/SOP/manufacturers instructions in restricted access area to prevent loss or use by unauthorised individuals.
- Maintain pharmacy temperature conditions and continuous temperature monitoring: record the storage temperature and relative humidity twice daily, except for the days off.
- Perform weekly uploads from the data logger records to an electronic device and USB key, and retain the printed version of data logger reports in the pharmacy site file.
- Assist with pharmacy quality assurance and quality control processes.
- Complete and maintain pharmacy records for the sponsor and regulatory audits.
- Assist monitors in drug accountability visits.
- Assist with procurement of trial medication.
- Receive trial drugs from suppliers; document receipt and resolve discrepancies.
- Maintain accurate and proper records for all drugs received and distributed by the trial pharmacy, according to trial SOPs.
- Verify investigator or designee has obtained informed consent from the patient.
- Prepare weekly medication blister packs for participants as per prescriptions from trial doctors, in accordance with trial SOP, under direct supervision of the trial pharmacist.
- Label trial medication before dispensing, in accordance with trial SOP, under supervision of the trial pharmacist.
- Dispense trial medication, as per specific protocol/SOP requirements, under the supervision of the trial pharmacist.
- Counsel and educate patients on drug administration, side effect, and adherence under direct supervision of the trial pharmacist.
- Receive and reconcile IP returns.
- Assist with pill counts and adherence monitoring.
- Return and/or properly dispose of trial drugs as per protocol/SOP.
- Maintain stock control and a record of dispensed medication, according to trial SOPs.
- Maintain IP accountability records.
- Maintain prescription records against which IP is dispensed.
- Maintain pharmacy sections of the Site Master File.
- Communicate with trial medical officers, nurses, and sponsors when needed.
- Attend regular meetings with the endTB trial team.
- Attend meetings related to the endTB trial, including at MSF, and community forums.
- Contribute to advocacy activities within the MSF endTB team, and Khayelitsha project as a whole.
Education & Registrations
- Formal Pharmacist assistant post basic qualification (registered as a Post Basic Pharmacist Assistant with the South African Pharmacy Council)
- South African citizenship or a valid work visa
- Minimum one years previous experience in drugs management preferable in clinics with high burden TB setting
- Knowledge and experience of current pharmaceutical stock control system
- Previous clinical trial experience (advantageous)
- GCP training (advantageous)
- Knowledge of applicable laws and regulations
- Word and all other basic office software (essential)
- Use of online databases
- Strong interpersonal and communication skills and the ability to work in a team
- Excellent organizational skills
- Able to function independently
- English (fluent, spoken/written required)
- isiXhosa (advantageous)
- One year fixed-term field contract (extendable)
- Salary according to MSF-OCB Field salary scale. Medical aid + 10% towards retirement
Expected starting date: November 2017
To apply please email a one page application letter, your comprehensive CV with details of 3 contactable referees to: [email protected]
|Contact person||Danielle Piet|