Consultant - Clinical research in R&D initiatives

Purpose of consultancy

To conduct clinical research on COVID-19 therapeutics Solidarity Trial initiatives and related activities.

Background

While the research for an effective treatment continues, WHO has cautioned recommending or administering unproven treatments to patients with COVID-19 or people self-medicating with them until there is sufficient evidence. Far more clinical evaluation and testing is needed to determine if new treatments and/or existing treatments can effectively be used or repurposed to target COVID-19. If proven efficacious, large numbers of deaths could more rapidly be avoided by one or more of these treatments.

In order to fast-track this research, Dr Tedros launched Solidarity Trial on 18 March 2020 as a large international clinical trial to help find an effective treatment for COVID-19. Enrolling patients in one single randomized trial will help facilitate the rapid worldwide comparison of unproven treatments and overcome the risk of multiple small trials not generating the strong evidence needed to determine the relative effectiveness of potential treatments.

Since its launch, more than 40 countries are participating and many more are expected to join as the Therapeutics Solidarity Trial entered a second phase of implementation with new treatments to evaluate for their potential to improve treatment outcomes for SARS-COV-2 and related variants.

In light of the limited extra capacity to support the implementation of this global trial and the ever evolving epidemiological scenario of the coronavirus, dedicated expert support is quickly needed to assist the national authorities and researchers in all participating countries through each of the various steps necessarily to implement the therapeutics clinical trial according to Good Clinical Practice (GCP) and all applicable regulatory and ethical requirements, and strict adherence to the WHO core protocol.

Deliverables

Output 1:

Activity 1.1: Provide guidance on the finalization and submissions for ethical and regulatory approval, of protocol amendments for the addition of new treatment arms.
Expected by: 15.03.2023

Activity 1.2: Coordinate the handling and documentation of study drugs in line with GCP and regulatory requirements.
Expected by: 15.03.2023

Output 2:

Activity 2.1: Contribute to the design, planning, implementation, and evaluation of Solidarity clinical trials in participating countries including bridging between the representatives of the ministries and national health institutes and WHO.

Activity 2.2: Coordinate the implementation of the Trial in countries according to the WHO core protocol.
Expected by: 01.06.2023

Output 3:

Activity 3.1: Provide guidance on the end-to end process at country level to be able to participate and launch clinical trials from: (i) appointing a national principle investigator and national coordinator of the Solidarity Trial, (ii) identifying hospitals with substantial numbers of COVID- 19 cases that will collaborate, (iii) facilitating ethical and regulatory approvals of the WHO study protocol; (iv) identifying the study drugs available in each location, (v) facilitating import permits for study drugs as needed, (vi) setting up personnel and logistics for study implementation within local hospitals, move quickly into rapid recruitment; (vi) facilitating the training of the hospital clinicians on the WHO centralized randomization and data system.

Activity 3.2: Ensure the distribution of trial drugs to each participating site.
Expected by: 15.09.2023

Activity 3.3: Ensure that local principal investigators and local monitors enter all patient data on a timely basis in the web-based randomization platform (Castor EDC) and follow-up promptly on any missing data points.

Activity 3.4: Address the scientific and technical issue on the Solidarity Trial and ensure compliance with the fundamental ethical principles of research principles, providing continuous guidance in assuring the protection of research participants and good research practices.
Expected by: 15.11.2023

Qualifications, experience, skills and languages

Educational Qualifications

Essential:

• Advanced university degree (Masters level or above) in a health/life sciences, public health, or related field.
• Training in clinical research.

Desirable:

• PhD degree in a related health/life sciences.

Experience

Essential:

• A minimum of eight years' experience in clinical research/clinical operations management and conducting of clinical trials.

Desirable:

• Prior work experience with WHO and/or UN agencies or other international organizations.
• Experience with the WHO R&D Blueprint and experience working in LMIC countries.

Skills/Knowledge

• Strong skills in the field of clinical research/clinical operations management.
• Good Clinical Practices (GCP); epidemiology.
• Excellent written and oral communication skills.
• Demonstrated ability to communicate effectively on complex issues.
• Strong interpersonal skills and team spirit.
• Ability to work under tight deadlines on a results-oriented basis.
• Good planning skills and ability to handle multiple tasks and priorities.

Languages required

Essential:

Expert knowledge of English.

Desirable:

Intermediate knowledge of French.

Location

Off site: Home-based

Travel

The consultant is expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level B - USD 7,000- 9,980 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

11 months

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.
• For information on WHO's operations please visit: http://www.who.int.
• WHO is committed to workforce diversity.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• 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 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 final candidates.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
• WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. 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.
• Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html