MAIN OBJECTIVE OF POSITION
To ensure the proper conduct of the LASCOPE (Lassa fever clinical Course and Prognostic factors in an Epidemic context in Nigeria) research study which takes place within the Infection Control and Research Center (ICRC) in the Federal Medical Center in Owo (FMCO), Ondo State, Nigeria. The study site coordinator is responsible for the conduct and monitoring of the LASCOPE study, ensuring the compliance with the study and Good Clinical Practice (GCP) protocols, managing the research team, and be actively involved in case management alongside the case management team in the ICRC.
This is an exciting opportunity to gain experience in operational clinical research, working alongside an international team of doctors, nurses and researchers. The post holder will receive regular training in clinical research methods, as well as the use of advanced clinical monitoring equipment.
FUNCTIONAL AND HIERARCHICAL LINES
Reports to Field Research Coordinator and Collaborates with Project Coordinator and ALIMA medical/research operational team
ORGANIZATION OF THE STUDY
- The Study Site Coordinator will work a shift-based system in the ICRC, in both the suspect and confirmed Lassa fever wards.
- Is responsible for the organization of the research activities in close collaboration with case management team
- Ensure that the research team is using the tools provided by ALIMA and for participant admission, inclusion, follow up.
- Ensure that the research team complies strictly with the study protocol, standard operating procedures (SOPs), information and consent process as well as GCP
- He/she is the guarantor of the smooth coordination between the research team and the case management team members (some of them could belong to both teams).
MONITORING AND REPORTING
- Monitor research activities, analyze them in context, and, if necessary, make proposals on their possible evolution
- Report immediately to the Field Research Coordinator any scientific or medical problem arising regarding the conduct of the study
- Report immediately to the technical support representative and the Field Research Coordinator any administrative/financial/logistical problem arising regarding to the conduct of the study
- Ensure that all the informatics devices (computers, printers, scanners) are working correctly and report any dysfunction to the local support representative and to Field Research Coordinator
- Immediately report any serious adverse events to the Field Research Coordinator
- Will interact at least weekly with the Field Research Coordinator regarding the progression of the study.
- Is co-responsible for monitoring the safety and the quality of the biobank in collaboration with the VHF lab team members.
CONDUCT OF THE STUDY
- Make sure that all the eligible patients are proposed to participate in the study following their admission
- Ensure that all the participants have been fully informed on the study procedures before they sign their consent form. Verify the signature of the consent form
- Coordinate with the research team to make sure that all the CRFs for all the participants are completed in a timely manner
- Collect the results of biological analysis for all the participants and fill the corresponding CRFs (including the Lassa RT-PCR)
- Collect information required about dialysis and pregnancy/deliveries, when applicable
- Make sure that no information is missing in the CRFs before the participant is discharged. Collect missing information if needed from participants or their medical file in a timely manner.
- Ensure that none of the sample collections or analyses are financially charged to the participants.
- Organize the follow-up of the patient after discharge and ensure that the follow up CRFs are filled accurately
- Participate in the promotion of the study within the FMCO
- Is responsible for, in collaboration with the Field Research Coordinator, maintaining the study master file (containing the protocol, amendments, SOPs, information and consent forms,…) and ensuring that all the updates have been integrated
- Will ensure the total anonymity of participants in the study
- Is responsible for assisting in the internal and external data monitoring activities in collaboration with the Field Research Coordinator. Ensures the availability of patient files and accesses the hospital Archives to get patient files that are needed. Ensures the corrections made during the monitoring process are done.
- Is responsible for the trainings of the research staff according to the study protocol
- Apply medical knowledge and skills to the diagnosis, treatment, and prevention of Lassa fever and differential diagnosis
- Participate in the daily medical rounds of patients in the ICRC in collaboration with case management team and in accordance with local procedures
- Propose and ensure the implementation of the appropriate treatment, in accordance with the recommendations and protocols of the FMCO and ALIMA. Consult the ALIMA project coordinator in charge of supervision of medical activities in the ICRC and the case management team for any particular case
- Follows the infection prevention and control procedures and protocols in relation to VHF in the ICRC
- Stay informed on patient triage, including in other departments in the FMCO (i.e accidents and emergencies) or outside the hospital, in collaboration with the person in charge of ensuring the correct identification and location of suspect and confirmed patients
- Stay informed of admissions of Lassa patients (suspected or confirmed) at the administrative/medical level and ensures the transmission of this information to the Field Research Coordinator.
- Consults immediately any case showing signs of seriousness and takes all the necessary measures for proper management.
- Maintain doctor-patient confidentiality
- Respects the operating rules of the ICRC and ensures they are respected by all the medical staff
- Participates in the identification of new needs in terms of drugs and medical facilities, according to the pathologies encountered during practice.
- Participates in medical discussions based on knowledge and area of expertise
- Maintains their knowledge of the ALIMA association, including its operation, structure, internal rules and procedures, and respects and applies ALIMA’s values
- Keeps up to date with the objectives and activities of the research study
- Maintains awareness of the activities of other departments within ALIMA
- Participates in departmental and all study-related meetings, and develops team spirit and solidarity
EXPERIENCE AND SKILLS
- Medical Doctor
- Additional training in clinical research is desirable
- At least 2 years experience working as a medical doctor
- Experience in clinical research, including data collection, is essential
- Experience in a hospital medical service
- Knowledge of at least one data entry software
- Experience in an infectious disease department would be appreciated
- Knowledge of at least one Office Pack software is desirable
- Fluent English is essential. Yoruba language skills are desirable
- Qualities of the candidate: autonomy, rigor, organization, flexibility, diplomacy and commitment
NB: This job profile is not exhaustive, as it could change from time to time according to the needs of the mission.