The US President’s Malaria Initiative (PMI)in collaboration with the National Malaria Elimination Programme (NMEP), plans to conduct the 2020 Therapeutic Efficacy Studies (TES) in three select sites beginning July 2020.
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 a Clinical Monitor for the 2020 TES who will receive direction from the TES Technical Consultant.
S / he 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 one Clinical Monitor.
The 2020 DTES will be conducted in three Sentinel sites located in Adamawa, Cross River and Sokoto 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 approved protocol.
Work with TES Technical Consultant 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 Consultant with preparation of information for inclusion in monthly report to client.
Knowledge, Skills and Competencies
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.
MD (or equivalent) with a minimum of at least 5 years’ experience in clinical research and / or as a Clinical Monitor.