Field Clinical Research Coordinator - M / F - Nigeria at Alliance for International Medical Action (ALIMA)

Location: Owo, Ondo
Employment Type: Contract
Contract term: Contract under French law, 6 months
Desired start date: As soon as possible

Background

• Lassa fever (LF) is a viral disease that can lead to a syndrome of viral haemorrhagic fever (VHF). Lassa virus is distributed throughout West Africa. It is transmitted to human from the rodent reservoir.
• The disease was first reported in 1969 in the locality of Lassa in Borno State, Nigeria. Lassa fever is endemic and Nigeria and is experiencing seasonal resurgence during the dry season (December to May).
• Ribavirin (antiviral) has been the recommended treatment since the 1980s, but its efficacy remains weakly evidenced. Moreover, it has adverse effects and is costly for endemic countries. There is currently no vaccine available. Lassa fever is considered by WHO as a priority disease for urgent research and development.

Mission and Objectives

• In addition to prevention and case management, the CORAL platform (ALIMA / Inserm) is currently setting up a therapeutic phase II clinical trial. This trial in partnership with BNITM, a German research institute, will assess the safety and efficacy of the antiviral drug Favipiravir against the standard ribavirin treatment. It is an important step towards a phase III trial to identify an efficacious drug against Lassa fever.
• To better understand the disease, the platform is also developing an observational cohort study since 2018 (LASCOPE) to describe the clinical, biological course, management and outcomes of hospitalized patients with a diagnosis of confirmed Lassa fever.
• As part of the studies conducted in Owo on Lassa fever, we are looking for a Field Clinical Research Coordinator of (FCRC) who will represent and assist in Nigeria the international coordinators and principal investigators of research projects on Lassa fever conducted by our consortium in Nigeria (LASCOPE cohort study and related projects).
• He / She will ensure the smooth running and daily management of the research projects in all their aspects: scientific representation, management of staff dedicated to clinical research activities, control and quality assurance of data collection, respect of protocols and procedures, supervision of internal monitoring and implementation of external data monitoring, participation in the organization and implementation of proximity training of clinical research staff.
• Under the supervision of the international coordinators of the project (INSERM / ALIMA), he / she will work in close collaboration with the "Infection Control and Research Center" (ICRC) team and the "Viral Hemorrhagic Fever Laboratory" team (VHFL) of the "Federal Medical Center" in Owo (FMCO), as well as the ALIMA response team deployed in this site.

Tasks & Responsibilities

• The coordinator is responsible for conducting research activities on Lassa fever in Owo.
• She/He is in charge of supervising data collection, ensuring study protocol and procedures are enforced, coordinating research human resources and logistic for the studies.
• She/He works under the supervision of the Project Coordinator and the international CORAL scientific team and in close collaboration with the laboratory manager and the hospital staff.

He/she:

Coordinate:

• Coordinate and supervise the work of the Clinical Research Team of the ICRC (Physicians and Nurses), ensure that their work is done in accordance with the protocol and procedures of the studies.
• Ensure the quality and continuity of information exchange between the VHFL and the ICRC (compliance with procedures, quality of communication between the two departments).
• Participate in the steering committee and the operating committee of the various studies. 
• Report to the coordination team any problems or difficulties encountered in the field and discuss ways to resolve them.

Manage:

• Ensure the quality of data collection tools (CRFs, registers, databases) and compliance with procedures.
• Ensure that the delivery of information to participants and the collection of consents is in accordance with the clinical good practice, protocol and procedures of the study; Collect and secure all consent forms (onsite).
• Ensure data transfer (CRFs) to the Methodology Center (PACCI Abidjan), ensuring the rhythm given by CORAL coordination.
• Maintain the general management tools of the study (TMF and eTMF)
• Supervise the internal monitoring and perform the external monitoring data; Ensure the administrative management of studies (salaries, incentives, HR management ...) 
• Ensuring the replenishment of laboratory items and the payment of suppliers. 
• Respect and enforce confidentiality towards participants in the different research projects. 
• Respect the operating rules of the ICRC (hygiene, infection prevention and control).

Collaborate:

• Organize and facilitate the relations and the exchange of information between the emerging infectious diseases coordination team (Paris, Bordeaux), the sponsor of the studies and the Nigerian collaborators on field.
• Ensure effective collaboration with other departments of the hospital (emergency room, dialysis unit, pediatrics, gynecology ...) concerning the Lassa fever studies in Owo.
• Participate in the Lassa fever response plan provided by the ALIMA medical team, under the supervision of the ALIMA medical coordinator.

Implements Prevention Measures Against Abuse of Power, Gender-Based and Sexual Violence:

• Ensures that community members are aware of the policy and have access to information (complaint escalation mechanism, focal point...).
• Participates as needed in the organization of training and awareness sessions
• Applies the standards related to the prevention of abuse of power, gender-based and sexual violence.
• Contributes to creating and maintaining a fulfilling and protective environment for his/her team, community members.

Protection Of Beneficiaries and Community Members:

• Level 3: The incumbent is responsible for the application of Research processes and may be required to conduct field visits. She/he. He/she may therefore be in contact with children and/or vulnerable adults. Therefore, a criminal record check or the presentation of a certificate of good conduct will be required. In situations where the impossibility of providing a criminal record or a certificate of good conduct is established, a declaration on honour will be requested.

Experience and Skills
Educational:

• Clinical care experience
• Experience in clinical research is a plus.
• Experience in a developing country and / or field experience is recommended.
• Fluent English.

Qualities of the Candidate:

• Sense of communication, diplomacy and flexibility are essential; Management abilities; Spirit of initiative; Teaching skills; Rigor and organization are essential.

Salary

• Depending on experience.

ALIMA Pays for

• Travel costs between the expatriate’s country of origin and the mission location
• Accommodation costs
• Medical cover from the first day of the contract to a month after the date of departure from the mission country for the employee
• Evacuation of the employee.