Laboratory Advisor (EDCTP TRiAD multicenter cohort study) 66 views

KNCV Tuberculosis Foundation

KNCV Tuberculosis Foundation (KNCV) is one of the leading international non-profit organizations dedicated to fighting tuberculosis (TB) worldwide. We are an international center of expertise for TB control that stimulates effective, efficient and sustainable tuberculosis control strategies in a national and international context. We are an organization of passionate TB professionals, including medical doctors, researchers, training experts, nurses and epidemiologists.

Over the past century, we have built a wealth of knowledge and expertise, initially by successfully driving back TB in the Netherlands, and subsequently by partnering in the fight against TB in over 40 countries worldwide.

We operate from a central office in The Hague in the Netherlands and additional country offices worldwide. KNCV raises funds from individual, institutional and corporate donors.  In Ethiopia, KNCV has more than 13 years of experience in comprehensive TB program support of the national program.

Background

Ongoing transmission of drug-resistant tuberculosis (DR-TB) remains a major obstacle to the United Nations (UN) End-TB strategy. To reach targets of 90% reduction in tuberculosis (TB) incidence and mortality by 2035, implementation of new and improved diagnostic and treatment approaches are urgently warranted. This study will adopt a Triage-and-Treat approach using novel TB diagnostic technologies to guide implementation of short, all-oral regimens for DR-TB.

The TriAD study is a multi-center, multi-country Prospective Pragmatic Cohort study assessing the effectiveness, feasibility, acceptability, and cost-effectiveness of implementing the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB. The proposed study aims to screen approximately 4800 GeneXpert MTB/RIF or Ultra positive (irrespective of rifampicin resistance status) patients from 9 study sites in South Africa (2), Nigeria (2) and Ethiopia (5) to enroll 880 rifampicin-resistant (RR, cohort 1) and 400 isoniazid-resistant (HR, cohort 2) patients. The Xpert XDR assay that tests for resistance to isoniazid, fluoroquinolones and second-line injectable agents, will be implemented as a reflex test to provide rapid genotypic susceptibility testing for DR-TB detection and its result will be used for selection of appropriate, evidence-based all-oral DR-TB treatment regimens of shortest possible duration. In parallel, the molecular bacterial load assay will be used to provide bacillary load monitoring over the course of treatment to assess real-time treatment response.

Outcome data among patients enrolled in Cohort 1 of this study will be compared to historic outcome data of similar DR-TB patients diagnosed and managed at study sites 12-18 months before the proposed prospective study. Diagnostic data of Xpert XDR assay screening for HR, pre-XDR and XDR will inform optimal placement of Xpert XDR within the current DR-TB diagnostic algorithm. Furthermore, operational and cost-effectiveness research generated in this study will be used to inform policies and guidelines for programmatic implementation of the triage-and-treat model.

 Purpose of the position and organizational position

In Ethiopia, five DR-TB treatment initiation centers (TICs) will need to enroll approximately 220 patients for cohort 1 and 100 patients for cohort 2 over the course of 18 months for the main study. For these patients, baseline and follow-up data will be collected (demographic information, detailed information about all assessments done at baseline, clinical response to treatment, as well as any treatment changes, adverse events, etc.). Additional data will be collected for cost-effectiveness and feasibility and acceptability side studies.

In Ethiopia, this project is carried out by the Ethiopian Public Health Institute (EPHI)in collaboration with   KNCV.

As a Laboratory Advisor, you are expected to:

• Coordinate and monitor the laboratory aspect of the TriAD main and sub-study;
• Monitor appropriate laboratory testing as per the study protocol;
• Follow and monitor the laboratory aspect of the BPal wing of the study is on track;
• Work with the Project coordinator, EPHI and the five treatment sites and supervise the laboratory aspect of the TriAD study.
• The Laboratory Advisor works closely with the TRiAD in-country team (KNCV and EPHI), the focal person for TriAD at EPHI, with responsible laboratory personnel in the five centers enrolling patients for this study and the data management unit of EPHI.

Place in the organization

• The Laboratory Advisor reports hierarchically to the TriAD project coordinator; functionally to TriAD in country team and the TriAD study team at KNCV HQ.

Profile

As Laboratory Advisor you will:

• Coordinate the laboratory aspect of the main and the sub-studies;
• Closely collaborate and coordinate the laboratory activities with the EPHI focal person and the Project Coordinator for the TriAD study;
• Oversees installation of the 10 colored Xpert machines at the study sites;
• Do monitoring of the annual calibration schedule and facilitate the health facility level Gene Xpert machine calibration;
• In collaboration with EPHI, oversees the curative maintenance and replacement of modules at the selected sites;
• Monitor accuracy and completeness of site level TRiAD study related laboratory data;
• Monitor on time and appropriate testing of samples at five study sites takes place;
• Identify knowledge gap at the health facility level and initiate and guides further capacity building;
• Do joint site visits and monitoring to supervise site level performance together with the EPHI team and the Project coordinator;
• Ensure the timely implementation of the preventive maintenance of the Gene Xpert machines;
• Oversees the standard operating procedure is in place and being followed in sample collection and transport mechanisms;
• Coordinate and lead the sputum sample transport from the five sites to EPHI for culture/DST and MBLA;
• Collaborate and work with EPHI to facilitate the sample collection, storage and transportation of sub-cultures which will be shipped to Tuberculosis Supranational Reference Laboratory, San Raffaele Scientific Institute (OSR) for specialized tests such as MIC and WGS;
• Support EPHI in providing trainings on culture /DST and MBLA for NRL;
• Oversee the Xpert MTB/XDR testing at the five sites level in collaboration with EPHI;
• Coordinate trainings concerning the study for health professionals at the site level;
• Provide trainings for the Laboratory professionals from the five health facilities on Xpert MTB/XDR and MBLA;
• Participate in workshops prepared on the TriAD study;
• Attend the scheduled meetings on TriAD study and update the status of the laboratory aspect of the study to the team together with the EPHI focal person of the study;
• Participate in other scheduled activities;
• Ensure the laboratory aspect of the study is implemented according the study protocol;
• Get familiarized with the study protocol, data collection tools and consent form of the study;
• Maintain diplomacy and confidentiality;
• Other related necessary duties as per the supervisor’s request.

What does KNCV Tuberculosis Foundation offer?

• A full time (40 hours) fixed-term contract for one year, with the intention to extend the contract;
• An informal work atmosphere in an international environment, where initiative is appreciated;
• A highly motivated team of experienced, self-driven colleagues;
• The salary is dependent upon education and relevant working experience:
• The KNCV Tuberculosis Foundation has its own HR Manual.

Qualifications and experience

• B.Sc. in medical Laboratory Technology/Science and Master’s degree in Medical Laboratory Sciences or equivalent;
• Minimum of 7 years of post-qualification experience including experience working in the field of Tuberculosis;
• Sound knowledge of the basic principles, techniques and safety procedures and quality management in the GeneXpert and advanced TB laboratory system;
• Training on Gene Xpert equipment is mandatory;
• Knowledge on other molecular diagnostic;
• Training on Gene Xpert maintenance is desirable;
• Training and experience on culture and DST service;
• Experience with laboratory information systems;
• Able to pay close attention to detail;
• Excellent people skills;
• Ability to work as part of a team and independently;
• Ability to cope with stress and to organize and prioritize workload;
• Supervisory, training, management and monitoring skills of lab technicians;
• Excellent oral and writing skill in English.