Consultant: Clinical trials

Contractual Arrangement

External consultant

Contract Duration (Years, Months, Days)

Part-time (40 days within 3 months period)

Job Posting

Aug 4, 2024, 5:45:38 AM

Closing Date

Aug 18, 2024, 2:59:00 PM

Primary Location

Egypt-Cairo

Organization

EM/SID Science, Information and Dissemination

Schedule

Part-time

IMPORTANT NOTICE: Please note that the deadline for receipt of applications indicated above reflects your personal device's system settings.

• 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.

• 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.

• 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.

• Qualifications, experience, skills and languages
  
  

Essential

Educational Qualifications:

• 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.
  
  

Essential

Experience:

• 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
• Location
  
  

Cairo, Egypt

• Planned timelines (Subject to confirmation)
  
  

Start date: 15 September 2024

End date: 18 December 2024

Duration of the consultancy: 40 days

• Medical clearance
  
  

The selected Consultant will be expected to provide a medical certificate of fitness for work.

• 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.
• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. 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.
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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 [email protected]

• 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.
• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). 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.
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• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority.
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