Study Organizer - Combine Field experiment - Agreement at Epicentre in Bauchi

About the Combine Study

Combine is a global, multi-centre clinical field experiment operational base targeting to assess new therapeutic options for Lassa fever (LF)—a disease with high mortality and limited treatment alternatives. The study compares investigational medical goods to standard care in hospitalized patients with validated LF, using a adaptable, adaptive Stage II–III design. Among other study sites in West Africa, the field experiment will take place at the Lassa Fever Treatment Centre (LFTC) inside the Abubakar Tafawa Balewa Tertiary institution Training Hospital (ATBUTH) in Bauchi, Nigeria, helped by MSF’s crisis medical project of Geneva Business Centre (OCG). The Study Organizer will be based in Bauchi, operating closely with MSF and Epicentre teams, and with the Chief Investigator from ATBUTH.

Your Core tasks

• Under the hierarchical oversight of the Epicentre Analysis Director or assign, and the operational monitoring of the MSF/OCG Project Medical Referent (PMR) in Bauchi  and the Chief Investigator, the Study Organizer will:
• Organize a study team comprising clinicians, nurses, data track, data managers, records entry clerks…
• Ensure procedure adherence and GCP guidelines across the study on-site.
• Manage execution of study standardized processes and quality of data collection, in partnership with the field experiment sponsor’s data governance and supervising team.
• Arrange and supply development for clinical and assistants on GCP, agreeing standardized processes, procedure-specific standardized processes, and Lassa fever care procedures.
• Ensure precise and on-schedule finish of Acquire Documents, Case Documentation Forms (CRFs) and other data resources.
• Oversee recordkeeping and client engagement of adverse events (AEs) and serious adverse events (SAEs).
• Preserve and modify the Investigator On-site File (ISF).
• Assist MSF project teams in conceptualizing and executing retention plans to avoid lost to client engagement.
• Organize standard procedure and ad hoc documentation in adherence with study and sponsor qualifications.
• Organize and coordinate the on-site supervising visits executed by the field experiment monitoring instances.
• Be a focal point for the study in MSF and offer frequent updates/documentation on the study advancement to Epicentre,  the PMR, the MSF medical synchronization, and the LFTC MoH organizer  as requiredLiaise with Hospital/Ministry of Health members and with the Combine consortium members as needed
• Support to system manuals, development resources, and position helps for health care workers and study team.
• Diagnose issues on-site-level concerns connected with HR, tools, or logistics, which includes communication link with Epicentre, MSF, and local governing bodies.
• Organize project closure initiatives and distribution endeavors.
• Uphold Epicentre and MSF’s ethical principles, which includes the respectful carry out of analysis in at risk populations.
• Execute other obligations as necessary by the project and purpose and in accord with supervisors

Credentials Education:

• Medical academic qualification (MD or equivalent) necessary. Specialization in Infectious Diseases or Intensive Care medicine is an asset.
• Academic qualification in community health, epidemiology, or clinical analysis is a robust asset.
• Deep knowledge of Good Clinical Practice (GCP).

Industry experience:

• Necessary: At least 3 years of expertise executing clinical field experiments in low-asset settings.
• Expertise operating as a clinician in viral hemorrhagic fever circumstance is an asset.
• Expertise operating with MSF as a clinician is an asset.

Technical and people skills:

• Outstanding command of analysis project and team management – crucial 
• Outstanding corporate, logical, document-keeping, spoken communication and professional writing competencies.
• Capability to adjust to sophisticated and evolving environments and deliver within strict timelines.
• Cooperative and equitable management, robust people skills, team spirit and diplomacy.
• Capability to offer assistance / support beyond their specialization.
• Sense of duty, strictness. 

Languages:

Fluently spoken and documented English – C1 or above - crucial  French is an asset.

Other requirement:

In line with Nigerian governing bodies’ rules, priority will be provided to applicants who are nationals of ECOWAS member states.

Our offerings:

• Work in a diverse team at the overlap of analysis and humanitarian medicine.
• Engage with MSF’s business analysis schedule in a high-priority medical crisis.
• Be part of a purpose-led company with a cooperative and nurturing workplace.

Note

Only select applicants will be reached. Female applicants meeting the application evaluation benchmarks are firmly inspired to submit application.