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1. Purpose of consultancy
The 75th World Health Assembly resolution (WHA75.8) calls upon WHO to prepare global guidance on best practices to help Member States implement scientifically and ethically sound clinical trials.
The resolution also provides guidance on best practices for non-State actors in designing and conducting clinical trials and strengthens the global clinical trial ecosystem. The main purpose of this consultancy assignment is to map the current landscape of clinical trials in the Eastern Mediterranean Region (EMR), including regulatory and ethical issues that are the basis of clinical trials.
The initiative will also look into gaps, challenges, and factors that facilitate the process.
2. Background
WHO EMRO organized an expert consultation in November 2023 as part of a series of regional consultations that also took place in AFRO and AMRO.
The consultation was used to provide feedback for the guidance before its final review, clearance, and publication, in addition to the feedback that WHO/EMRO/SID provided based on Member States’ expectations in the region.
In addition, the expert consultation provided an opportunity for EMRO to revisit its current agenda of support for research in the region. Noting the EMR Advisory Committee on Health Research (ACHR) recommendations for the provision of technical support for other large-scale studies such as cohorts, the consultation was a unique opportunity for EMRO to revisit the wider agenda of the research program in the WHO in addressing country expectations and priorities.
SID is looking for a consultant (or consultants) to help strengthen the national ecosystem of clinical trials in the countries.
This will also improve capacity building across the region.
3. Work to be performed
The SID consultant will develop a set of recommendations for the most pragmatic way to strengthen the national ecosystem of RCTs in the region.
The proposed activities are:
· Review of clinical trials guidelines and procedures in place in-country and recommended by WHO, followed by a comprehensive report and recommendations.
This includes scientific, ethical, and logistics/project management aspects of the design, conduct, and reporting of clinical trials.
This will review how guidelines and procedures in place compared to the WHO guidance on best practices for clinical trials developed following WHA 75.7
· Conduct Field visits to clinical trial sites and review the guidelines and procedures in place.
· Conduct meetings with the National Ethics/Bioethics Committee members and relevant clinical researchers.
· Proposing the way forward to strengthen national capacities in clinical trials, and their governance.
· Facilitate a national workshop on strengthening clinical trials and large-scale observational studies.
· The work will focus on Egypt, Iran, Jordan, Pakistan, Saudi Arabia, and Tunisia, among other EMR countries.
This work will be performed through a set of activities in collaboration with SID and the relevant WCO outlined below:
TOR 1: To conduct a review of clinical trials guidelines and procedures by reviewing available material and conducting meetings with key stakeholders.
Deliverable 1.1 Develop basis of possible revised national clinical trial guidelines for EMRO implementation of WHO guidance for best practice for clinical trials, incorporating review recommendations.
Deliverable 1.2 Develop a comprehensive report highlighting the findings of the review, along with feedback from key stakeholders and a set of relevant recommendations.
Deliverable 1.3 Explore the utility and use of a CTU maturity framework, which aims to assist national health authorities in supporting the development of CTUs in their countries.
Facilitate EMRO input into an early draft of the CTU maturity framework.
Deliverable 1.3 Detailed analysis of clinical trials related ethical review processes to document status quo as basis for recommended improvements.
Deliverable 1.4 Develop manuscripts in collaboration with the SID team about clinical trials and large-scale observational studies in EMR and the role of CTU maturity framework in the EMR context.
TOR 2: To strengthen regional capacities in clinical trials and large-scale observational studies.
Deliverable 2.1 Plan regional seminars/workshops with the SID team on clinical trials and large-scale observational studies.
4. Qualifications, experience, skills and languages
Educational Qualifications:
Essential
· Medical degree and a Master’s degree in clinical research, epidemiology, or related fields.
Desirable:
· PhD/DrPH in clinical research, epidemiology, or related fields.
· A solid track record of conducting/leading clinical trials/RCTs.
Experience:
Essential
· Seven plus years of relevant experience conducting independent research, clinical trials, RCTs, data analysis and publishing public health-related issues in low-income countries.
· Documented field-based experience and exposure to fieldwork in low-income countries.
· Experience with quantitative and/or qualitative research methodologies and experience applying them in the public health context.
· Experience in supporting organizational and capacity development of national actors in an international context.
· Practical experience in working in support of national partner organizations, establishing and developing partnerships.
Desirable
· Experience in working in government, the UN, or the WHO
Skills/Technical skills and knowledge:
· Excellent technical writing skills with a focus on research
· Good communication and interpersonal skills
· Ability to work in a multicultural team and maintain effective working relationships with recognized experts and stakeholders
· Documented writing skills, including track record experience publishing public health-related papers in peer-reviewed publications.
· Publication related to clinical trials, RCTs, and large-scale studies.
· Demonstrated experience in working in multi-partner programmes.
· Demonstrated ability to communicate to multiple audiences, including donors and academics.
· Strong commitment and ability to deliver work on time under tight deadlines
· Strong methodological and analytical skills, with the ability to conduct research, identify and analyze literature relevant to the programme area
· Good planning and organizational skills, attention to detail and the ability to multi-task and work under pressure
· Strong IT skills: MS Word, Excel, PPT presentation software, web search engines
Languages and level required:
· Essential: Expert knowledge of English
· Desirable: French or Arabic
5. Location
Cairo, Egypt
6. Planned timelines (Subject to confirmation)
Start date: 15 September 2024
End date: 18 December 2024
Duration of the consultancy: 40 days
7. Medical clearance
The selected Consultant will be expected to provide a medical certificate of fitness for work.
8. Travel
Travel is expected within EMR.
Additional Information
· This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO).
The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
· The WHO is committed to creating a diverse and inclusive environment of mutual respect.
The WHO recruits workforce regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics.
The WHO is committed to achieving gender parity and geographical diversity in its workforce. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply for WHO jobs.
Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process.
Requests for reasonable accommodation should be sent through an email to reasonableaccommodation@who.int
· An impeccable record for integrity and professional ethical standards is essential.
WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter (https://www.who.int/about/who-we-are/our-values) into practice.
All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct.
To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of short-listed candidates.
The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
The successful candidate will be asked to provide relevant evidence related to this condition.
A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at shws@who.int.
Click the link for detailed guidance on completing job applications: Instructions for candidates .
REQUIRED EDUCATION: Bachelor Degree
EXPERIENCE REQUIREMENTS: 60
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