Background
The US President’s Malaria Initiative (PMI)in collaboration with the National Malaria Elimination Programme (NMEP), plans to conduct the 2021 Therapeutic Efficacy Studies (TES) in four select sites beginning July 2021.
In Nigeria, TES is coordinated by the TES Core Team with membership from WHO, PMI and NMEP. The MSH-led President’s Malaria Initiative for States (PMI-S) Project is leading the process on behalf of PMI.
We are seeking to engage 2 Clinical Monitors for the 2021 TES who will receive direction from the TES Technical Coordinator. They will lead the independent monitoring of implementation of the approved protocol at the sites and development of site-specific standard operating procedures “SOP”. There will be two Clinical Monitors. The 2021 DTES will be conducted in four Sentinel sites located in Kaduna, Imo, Kwara, and Lagos states.
Main Duties and Responsibilities
Responsible for all activities related to the implementation of the clinical monitoring of study and assure work is done according to the approved protocol.
Work with TES Technical Coordinator to develop and implement Clinical Monitoring Plan as required by SOP
Team Duties / Responsibilities:
Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes including:
Regulatory document collection and review.
Develop site/monitoring tools and training materials.
Review and identify trends in enrolment and data entry at sites and proactively interface. with Principal Investigator and clinicians at site to identify solutions.
Oversee monitoring visit schedule to ensure compliance with frequency.
Manage quality and regulatory compliance among investigational sites.
Assist TES Technical Coordinator with the preparation of information for inclusion in monthly report to client.
Knowledge, Skills and Competencies
MD (or equivalent) with a minimum of at least 5 years’ experience in clinical research and /or as a Clinical Monitor.Thorough knowledge of clinical research process.
Excellent organizational and interpersonal skills.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple priorities within clinical trials.
Working knowledge of current ICH GCP guidelines and applicable regulations in Nigeria.
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