Clinical Monitor - 2020 Therapeutic Efficacy Study- the Management Sci...
The Management Sciences For Health (MSH)
Abuja
4d ago
source : BetaJob

Job Details

  • 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.
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