Project Coordinator (TriAD multicenter cohort study) 100% FTE 85 views0 applications


 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), supported by KNCV.

As a Project Coordinator, you are expected to:

  • Coordinate and monitor all aspects of the main study and sub-studies, including qualitative and quantitative implementation research and you are responsible for day-to-day coordination and management of the project;
  • Coordinate and monitor the BPaL wing of the study according to the Operational research guideline of the project, WHO and the national TB/HIV guideline;
  • Supervise the lab advisor working as full-time staff for the project.

The Project Coordinator works closely with the TRiAD country team (KNCV and EPHI), the focal person for TriAD at EPHI with clinical staff in the five centers enrolling patients for this study and the data management unit of EPHI.

Place in the organization

The Project Coordinator reports hierarchically to the KNCV Country representative and EPHI; functionally to the TriAD study team at HQ.

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.

Job Requirements

As Project Coordinator you will:

  • Support  the protocol development process in consultation with KNCV and EPHI  and the submission process for ethical approval to EPHI IRB and National Ethical review board;
  • Closely collaborate and coordinate all activities with the EPHI focal person for TriAD;
  • Lead in-country study preparation and implementation in line with the study protocol;
  • Participate in the development of project plans for the implementation of the research protocols in collaboration with KNCV and EPHI;
  • Get familiarized with the research protocols and (DR-)TB treatment implementation at the country level and develop all the necessary implementation research tools;
  • Based on the approved research protocols and guidance from the TriAD Team, train research councilors, interviewers, transcriptionist and translators, and other study team members;
  • Supervise the research counsellors, focal persons and the interviewers, transcriptionists and translators;
  • Monitor patient enrollment at the 5 TICs ensuring that maximum progress and quality is achieved;
  • Support and monitor data collection and timely data entry including data quality in collaboration with the Project M&E advisor and EPHI data management team;
  • Conduct simple analyses to facilitate monitoring of the project;
  • Participate in scheduled activities;
  • Participate in weekly KNCV TriAD calls, contribute to reports and scientific articles on the basis of the research conducted, ensuring high quality and timely delivery on all contractual and study related obligations in line with the approved study budget, including reporting;
  • Participate in scheduled TriAD consortium calls, and report about study progress for Ethiopia in these meetings;
  • Facilitate the operational arrangements required to effectively implement the research activity;
  • Maintain diplomacy and confidentiality;
  • Other related necessary duties as per the supervisor’s request.

Qualifications and experience

  • MD preferable with additional postgraduate qualification in public health or clinical medicine is desired;
  • At least 3 years’ experience, primarily in the field of health research, preferably on DR-TB including experience with working in DR-TB clinical trials;
  • In-depth knowledge of TB and DR-TB from clinical and programmatic perspectives and based on local NTP and WHO policies;
  • Experience in Clinical Research and knowledge of ICH/GCP;
  • Having completed a GCP course and Human Protection course is an advantage;
  • Able to pay close attention to detail;
  • Basic skills in applying statistical software for data validation and simple data analysis (cross tabulations, analysis of trends, etc.);
  • Excellent people skills;
  • Ability to work as part of a team and independently;
  • Ability to cope with stress and to organize and prioritize workload;
  • Excellent oral and writing skills in English and Amharic.

More Information

  • Job City Addis Ababa
  • This job has expired!
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KNCV Tuberculosis Foundation is a Dutch NGO devoted to eliminating the single most important infectious disease killer, TB. Our team includes physicians, nurses, epidemiologists, data-specialists, trainers and advocates, with expertise in all aspects of TB care and prevention. KNCV was established in 1903 as the result of Dutch civil society engagement against the TB epidemic. We are proud of these roots. Today, more than 350 employees worldwide contribute to our mission to free the world of TB. KNCV aims for sustainable progress and thus always works through national governments, ensuring optimal collaboration with technical and private sector partners at global and country levels.

What we believe At KNCV, we find it unjust and indefensible that millions of people still die from a curable disease. TB not only causes immense suffering for patients and their families, it also has a profound negative impact on the economic potential of communities, regions and countries. We believe that the investment case for TB is very strong. We believe that we can END TB provided that we generate, apply and share evidence and work in true partnership with all public and private partners, including patients. We believe that our experience in low prevalence countries, including diagnosis and treatment of latent TB infection, is relevant to End TB in high burden countries.

What we do KNCV combines evidence generation, technical assistance, policy development and advocacy under one roof. We offer highly specialized technical assistance at the country level with an emphasis on the adoption, evaluation and scale-up of new tools and strategies. As such, we contribute to local and global policy guidance while ensuring that country realities are taken into account. Our KNCV package includes important determinants of success in TB care and prevention such as health financing, stigma reduction, human resource management and digital solutions.

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0 USD Addis Ababa CF 3201 Abc road Fixed Term , 40 hours per week KNCV Tuberculosis Foundation

 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), supported by KNCV.

As a Project Coordinator, you are expected to:

  • Coordinate and monitor all aspects of the main study and sub-studies, including qualitative and quantitative implementation research and you are responsible for day-to-day coordination and management of the project;
  • Coordinate and monitor the BPaL wing of the study according to the Operational research guideline of the project, WHO and the national TB/HIV guideline;
  • Supervise the lab advisor working as full-time staff for the project.

The Project Coordinator works closely with the TRiAD country team (KNCV and EPHI), the focal person for TriAD at EPHI with clinical staff in the five centers enrolling patients for this study and the data management unit of EPHI.

Place in the organization

The Project Coordinator reports hierarchically to the KNCV Country representative and EPHI; functionally to the TriAD study team at HQ.

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.

Job Requirements

As Project Coordinator you will:

  • Support  the protocol development process in consultation with KNCV and EPHI  and the submission process for ethical approval to EPHI IRB and National Ethical review board;
  • Closely collaborate and coordinate all activities with the EPHI focal person for TriAD;
  • Lead in-country study preparation and implementation in line with the study protocol;
  • Participate in the development of project plans for the implementation of the research protocols in collaboration with KNCV and EPHI;
  • Get familiarized with the research protocols and (DR-)TB treatment implementation at the country level and develop all the necessary implementation research tools;
  • Based on the approved research protocols and guidance from the TriAD Team, train research councilors, interviewers, transcriptionist and translators, and other study team members;
  • Supervise the research counsellors, focal persons and the interviewers, transcriptionists and translators;
  • Monitor patient enrollment at the 5 TICs ensuring that maximum progress and quality is achieved;
  • Support and monitor data collection and timely data entry including data quality in collaboration with the Project M&E advisor and EPHI data management team;
  • Conduct simple analyses to facilitate monitoring of the project;
  • Participate in scheduled activities;
  • Participate in weekly KNCV TriAD calls, contribute to reports and scientific articles on the basis of the research conducted, ensuring high quality and timely delivery on all contractual and study related obligations in line with the approved study budget, including reporting;
  • Participate in scheduled TriAD consortium calls, and report about study progress for Ethiopia in these meetings;
  • Facilitate the operational arrangements required to effectively implement the research activity;
  • Maintain diplomacy and confidentiality;
  • Other related necessary duties as per the supervisor’s request.

Qualifications and experience

  • MD preferable with additional postgraduate qualification in public health or clinical medicine is desired;
  • At least 3 years’ experience, primarily in the field of health research, preferably on DR-TB including experience with working in DR-TB clinical trials;
  • In-depth knowledge of TB and DR-TB from clinical and programmatic perspectives and based on local NTP and WHO policies;
  • Experience in Clinical Research and knowledge of ICH/GCP;
  • Having completed a GCP course and Human Protection course is an advantage;
  • Able to pay close attention to detail;
  • Basic skills in applying statistical software for data validation and simple data analysis (cross tabulations, analysis of trends, etc.);
  • Excellent people skills;
  • Ability to work as part of a team and independently;
  • Ability to cope with stress and to organize and prioritize workload;
  • Excellent oral and writing skills in English and Amharic.
2021-06-21

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