endTB Internal Monitor wanted urgently: APPLY HERE
Khayelitsha, Western Cape
Job title: endTB Internal Monitor
Work Location: Khayelitsha, Western Cape
Duration: 12 months
Start date: 1 October 2019 (asap)
Reports to: Medical Coordinator
South Africa’s health, humanitarian, and socio-economic problems are characterized by extreme inequalities and uneven distribution of resources. Thirteen percent 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.
Based in Khayelitsha: A suitably qualified internal monitor will be employed to work on the endTB clinical trial. The purpose of the post is to manage the day-to-day quality control and quality assurance activities across the sites and to ensure trial procedures are in accordance with the protocol and Good Clinical Practice (GCP).
South African citizenship or a valid work visa
Minimum of 2 years working as an internal monitor in the health research field (Essential)
Previous clinical trial or research experience (Essential)
Experience working on MDR-TB patient clinical documents (advantageous)
Experience managing staff (advantageous)
GCP training (advantageous)
Additional/Desired skills, attributes, and experience:
Computer proficiency in MS Word and all other basic office software (essential)
Good analytical skills, as ease with figures and medical data
Strong interpersonal, Excellent communication and diplomatic skills, including writing skills
Ability to work in a multi-disciplinary team environment
Time management and problem-solving skills, excellent organizational skills to independently manage workflow
Ability to work independently and show initiative
Great attention to detail
Prior experience with MSF or similar NGO will be an added advantage
English (fluent, spoken / written)
PRINCIPLE ACTIVITIES and RESPONSIBILITIES:
Undergo training in the protocol, trial procedures, and GCP.
Travel to trial clinic sites in Khayelitsha.
Review Case Report Forms and other trial documents daily
Review participants’ clinical files, and perform Quality Assurance (QA) and Quality Control (QC).
Ensure data quality is of a high standard
Retain and manage source documents
Assist with data entry when required to do so
Verify that the Informed Consent Forms are complete, dated, and signed by the study personnel who obtained informed consent and the patient, and, if applicable, the parent, guardian, or legal representative
Verify that consent withdrawals have been properly documented
Review and monitor the Investigator Site File and Central Investigator File content regularly
Assist with additional tasks as agreed upon with study management
Attend regular meetings with the endTB trial team.
Attend meetings related to the endTB trial, including at MSF, clinical, academic, and community forums.
Contribute to advocacy activities within the MSF endTB team and Khayelitsha project as a whole.
Performs, when requested, any other additional duties given by the immediate supervisor in order to allow the organization to function optimally
Comply with all aspects of the Mission and Project Standard Operating Procedures manual.
Ensures that all documentation is completed to standard and within agreed timeframes.
Job Advantages and Career opportunities:
Experience in a well-known and professionally recognized international medical humanitarian organization
Salary package comparable to other non-profit organizations
100% medical aid 13th Cheque 10% contribution to pension
Please submit a one-page motivation letter, your comprehensive CV with details of 3 contactable referees. MSF reserves the right not to make an appointment if a suitable candidate cannot be found. While MSF thanks all interested applicants, only shortlisted candidates will be contacted.
Closing date: 25 September 2019
Job Type: Contract
managing staff: 1 year (Preferred)
previous clinical trial or research: 1 year (Required)
working with MDR-TB patients clinical documents: 1 year (Preferred)
working as an internal monitor in the health research field: 2 years (Required)
Education: Diploma (Required)
Licence: GCP (Good Clinical Practise (Preferred)