Clinical Monitor (2020 Therapeutic Efficacy Study) at the Management Sciences for Health (MSH)
The Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact. We work to save lives by closing the gap between knowledge and action in public health.
We are recruiting to fill the position below:
Job Title: Clinical Monitor for 2020 Therapeutic Efficacy Study
Job ref.: R10
Job type: Part Time
- 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 the 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:
- Oversee monitoring visit schedule to ensure compliance with frequency.
- Manage quality and regulatory compliance among investigational sites.
- Assist TES Technical Consultant with the preparation of information for inclusion in a monthly reports to clients.
- 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.
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.