NutriVax-Measles Trial Monitor at Alliance for International Medical Action (ALIMA)

MISSION AND OBJECTIVES

The trial monitor ensuring quality assurance and control over the process of inclusion and follow-up of the participant in the study in accordance with the protocol, trial procedures and good clinical practice (GCP) in the investigator sites to which they have been assigned.

PROTECTION OF BENEFICIARIES AND COMMUNITY MEMBERS

The incumbent is responsible for the application of HR processes and may be required to conduct field visits. 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.

TASKS & RESPONSABILITIES

•  Participate in meetings to set up the trial (training on the protocol, procedures and GCP);
• Participate in the organisation of the study in his/her area of assignment;
• Ensure that all enrolled participant meets inclusion criteria;
• Monitor the application of study procedure, and provide support to clinical research assistants when needed;
• Ensure that participant safety and confidentiality are respected;
• Review ICF, study form and source and e CRF;
• Support trial master file review and update;
• Ensure completeness and accuracy of data reported;
• Cross check source documents and compare them value reported in the e CRF;
• Support the Maintaining of records and registers of patients included in the study;
• Support the tracking of visit schedule for all participants and ensure none is missing;
• Support SQ-LNS distribution and documentation in PHCC;
• Support PHCC and health post in improving reporting of children anthropometric measure, vital parameters and immunization events;
• Participate in preparing and updating dashboard;
• Support research Clinical research assistant in solving application and tablet issues and seek support from IT team when needed;
• Raise queries for data verification, clarification and ensure data issues are corrected appropriately;
• Identify, notify and document protocol deviation and violation;
• Support the clinical research assistants in documenting adverse and severe adverse event;
• Conduct interim monitoring visit and provide report and participate in preparing study weekly progress report.

EXPERIENCE AND SKILLS

Candidate's qualities

• Medical Doctor with 2 years of field experience;
• Nurse with 4 years of field experience;
• Master in public health, epidemiology, research or any related field;
• Training certificate in clinical trial monitoring, in monitoring will be an asset;
• Knowledge and experience in the field of research
• Computer skills (data collection software such as Kobo, RedCap, Commcare, at least a good command of Excel) including skills in data visualisation and analysis;
• Knowledge and experience in child health;
• Respect for hierarchy
• Team spirit
• Organisational skills
• Rigour and precision
• Working under pressure
• Scientific ethics
• Good interpersonal skills
• Languages: English compulsory, others are an asset like Hausa, Kanuri etc.

Contract term: contract under Nigerian law, 3 months renewable with 2months of probation. Level 9