Clinical Research Assistant at ALIMA

ALIMA’S SPIRIT: ALIMA’s purpose is to save lives and provide care for the most vulnerable populations, without any discrimination based on identity, religion or politics, through actions based on proximity, innovation, and the alliance of organizations and individuals. We act with humanity and impartiality in accordance with universal medical ethics. To gain access to patients, we undertake to act in a neutral and independent manner.
Our CHARTER defines the VALUES and PRINCIPLES of our action:

Putting the Patient First
Revolutionizing humanitarian medicine
Responsibility and freedom
Improve the quality of our actions
Placing trust
Collective intelligence

ALIMA promotes and defends the principles of fundamental human rights. ALIMA has a zero-tolerance approach towards those guilty of acts of gender and sexual violence as well as towards inaction in the face of alleged or proven acts of violence. The protection of those benefiting from and impacted by our intervention is our top priority in everything we do. Everyone collaborating with ALIMA is committed to:

Respect the charter, the code of conduct, the institutional policies including the policy of protection against abuse of power and sexist and sexual violence, the policy of prevention of corruption and fraud;

Report any violation of the policies, framework documents and procedures to a superior, to a referent or to alert@alima.ngo
CARING - INNOVATING - TOGETHER:

Since its creation in 2009, ALIMA has treated more than 4 million patients and today deploys its operations in 11 African countries. In 2018 we developed 41 humanitarian medical response projects to meet the needs of populations affected by conflicts, epidemics and extreme poverty. All of these projects are carried out in support to national authorities through nearly 330 health facilities (including 28 hospitals and 300 health facilities). Whenever possible We work in partnership with local NGO's to ensure that our patients benefit from the best and most relevant expertise wherever it is, whether within their own country or in the rest of the world. In addition, to improve the humanitarian response, we are carrying out operational and clinical research projects particularly in the field of the fight against malnutrition and viral haemorrhagic fevers

ALIMA’S TEAM: more than 2000 people are currently working for ALIMA. The field teams, closest to the patients, receive their support from coordination teams generally based in the countries’ capitals. These receive support from the 4 desk teams and the emergency and opening team based at the operational headquarters in Dakar, Senegal. The Paris and New York teams are actively working to raise funds and represent ALIMA. The rest of the ALIMA Galaxy includes individuals and partner teams working on behalf of other organizations such as medical NGOs BEFEN, ALERT Health, SOS Doctors / KEOOGO, AMCP, research organizations PACCI and INSERM, Bordeaux or Copenhagen Universities, the INGO Solidarités International and many others.
COUNTRIES WHERE WE WORK: Mali, Burkina Faso, Central African Republic, Nigeria, Niger, Chad, Democratic Republic of Congo, Cameroon, Guinea, South Sudan, Mauritania.

THE WORK WE DO COVERS: Malnutrition, Maternal Health, Primary Health, Pediatrics, Malaria, Epidemics (Ebola, Cholera, Measles, Dengue, Lassa Fever), Hospitalization, Emergencies, Gender Based Violence, Opening / Closing.
BACKGROUND

Lassa fever (LF) is an acute viral illness (epidemic prone disease) that can result in a viral hemorrhagic fever (VHF) syndrome. The causative agent is the Lassa virus, which is primarily transmitted by rodents. The illness was first reported in Borno State, Nigeria in 1969. Since then cases and outbreaks continue to be reported in Nigeria with a seasonal resurgence during the dry season (December to May) and the diseases is increasingly recognized to be endemic in many other parts of West Africa.

Treatment includes the antiviral drug ribavirin since the 1980s and supportive care. However, there is relatively little scientific information on the disease and its treatment, and there is a significant need for research data. There is currently no vaccine available. Lassa fever is considered by WHO as apriority disease for urgent research and development.

In addition to prevention and case management from ALIMA, the CORAL platform created by ALIMA, PACCI programm (Côte d’Ivoire) and Inserm (France) have set up the LASCOPE cohort.

LASCOPE is an observational cohort study of Lassa fever clinical Course and Prognostic factors in an Epidemic context in Nigeria. It aims to describe the characteristics of inpatients admitted for a suspected diagnosis of Lassa fever in tertiary hospitals situated in the most affected Nigerian states since 2018. Its primary objective being to depict the clinical, biological course, management and outcomes of hospitalized patients with a diagnosis of confirmed Lassa fever. The study takes place within the Infection Control and Research Center (ICRC) in the Federal Medical Center in Owo (FMCO), Ondo State, Nigeria.

As well as LASCOPE, ALIMA, through CORAL, ALIMA aims to develop and set up others phase II and III clinical trials projects.

POST TYPOLOGY – FUNCTIONNAL AND HIERARCHICAL RELATIONSHP

Mission Location:

Clinical Research Assistant

Mission Location: Nigeria, Ondo State, Owo

Project: Clinical research and research cohort

Management lines:

• S/he will work under the direct supervision of Research Project Coordinator.
• S/he will work under the supervision of the International Clinical Research Assistant and the International project manager located at the International Clinical Trial Unit (ICTU) CORAL (Inserm/PACCI/ALIMA).

S/he will work in 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) and especially with investigational doctors, nurses and laboratory scientists.
• ALIMA’s operational coordination team in Owo including the laboratoty manager and the pharmacist.
• The data manager and the data entry located at the ICTU.

MISSION AND MAIN ACTIVITIES

• We are looking for a Clinical Research Assistant (CRA) who will ensure the proper conduct of the LASCOPE study which takes place within the Infection Control and Research Center (ICRC) in the Federal Medical Center in Owo (FMCO), Ondo State, Nigeria.
• S/he will ensure the proper conduct of the study according to the Good Clinical Practices (GCP).
• S/he will provide an onsite monitoring, data and queries verification and management of eTMF according to the monitoring plan and in collaboration with the ICTU in France.
• S/he will be led to work on other Lassa Research Projects conduced at the ICC by ALIMA and CORAL team.

Mission and Objectives

S/he will perform the following tasks:

Contribute to the implementation and smooth running of the study:

• Assist in the drafting and implementation of procedures
• Train, with the ICTU team, the clinical teams on the protocol and procedures of the study
• Participate in the development of data collection tools and facilitate the appropriation of these tools by the clinical teams
• Ensure the implementation and follow-up of essential study documents (e-TMF...) in the clinical site
• Ensure data transfer (CRFs) to the ICTU for the data entry
• Ensure compliance with Standard Operational Procedures and study documents (protocol,..)
• Ensure that the protocol schedule is followed for each participant
• Respect confidentiality and good clinical practices (anonymity of samples, respect of the protocol...)
• Report immediately to the Project Coordinator and the ICTU team any scientific or medical problem arising regarding the conduct of the study
• Report immediately to Project Coordinator and the ICTU teams any administrative/financial/logistical problem arising regarding to the conduct of the study

Ensure the monitoring of the study:

• Participate in the development and implementation of the monitoring plan (Chronogram, activities, reporting ...)
• Ensure control and quality assurance of data collection, completion on CRFs and database.
• Monitor the completeness and quality of the data
• Ensure the quality of data collection tools (CRFs, registers, databases) and compliance with procedures.
• Ensure compliance with the procedure for obtaining informed consent
• Verify compliance with the monitoring plan (clinical, pharmacy and lab)
• Write monitoring reports
• Follow up on the resolution of queries

Participate in teamwork:

Share with the International project manager and the International CRA information related to the study follow-up

• Actively participate in the coordination meetings of the project team
• Participate in training sessions offered by the study
• This is an exciting opportunity to gain experience in operational clinical research, working alongside an international team of doctors, nurses, laboratory scientists and researchers. The post holder will receive regular training in clinical research methods, as well as the use of advanced clinical monitoring equipment.
• Protection of Beneficiaries and Community Members:
• 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 honor will be requested.

Implementation of prevention measures against abuse of power, gender-based and sexual violence:

• Ensures that his/her team, partners and community members are aware of ALIMA's policy and have access to information (complaint escalation mechanism, focal point...).
• Facilitates the organization of training and awareness sessions
• Implements standards related to the prevention of abuse of power, gender-based violence and sexual violence.
• Ensures that team members and partners involved in the project (Ministry of Health, national partners, etc.) follow training and awareness sessions and apply the rules for preventing abuse.
• Contributes to creating and maintaining a nurturing and protective environment for his/her team, community members and project partners.

EXPERIENCE AND SKILLS

Educational and experience:

• Clinical Research Associate Certificate or equivalent
• Experience as Clinical Research Associate in clinical research including data collection and monitoring is required
• Good Clinical Practice and Good Laboratory Practice training
• Knowledge of at least one data entry software and Office Pack software is required
• Experience in a hospital medical service with Medical INGO would be appreciate
• Medical or paramedical training is a plus
• Experience in an infectious disease department would be appreciated
• Fluent English is essential. Yoruba language skills are desirable

Other qualities:

• Excellent interpersonal and communication skills, good judgment and a high level of respect for confidentiality
• Adherence to the ALIMA Principles and Charter
• Autonomy and flexibility
• Rigor and organization
• Diplomacy
• Commitment