Lead Monitor at Kenya Medical Research - KEMRI

JOB PURPOSE: 

This role is responsible for monitoring and providing oversight within the clinical trials facility as well as specific monitoring responsibilities for allocated studies. This position provides oversight for monitoring activities at the Programme as well as monitoring of clinical studies conducted by internal researchers or affiliates in other institutions. 

Description: 

REPORTS TO:  

• Research Governance manager  

DIRECT REPORTS: 

• Study Monitors  

FINANCIAL RESPONSIBILITY: 

• Manage CTF Monitor’s budget 
• Develops Monitor’s budgets  

KEY RESPONSIBILITIES:

• Manage and implement monitoring activities and schedules across the Programme. 
• Lead the development of monitoring strategies, budgets, guidelines, procedures, and tools. 
• Review monitoring plans and reports resolve issues and establish quality assurance. 
• Manage monitoring records and ensure safe keeping and ease of reference. 
• Conduct training needs and competency needs assessment for monitoring team. 
• Coach and mentor study monitors and additionally organise/facilitate refresher/relevant training opportunities. 
• Assess monitoring needs for study protocols and develop study specific monitoring plans. 
• Conduct variety of monitoring visits as per monitoring plan including site assessment, site initiation, routine visits (onsite, remote, central) & close out visits. 
• Verify protocol and regulatory compliance for each study.  
• Review all laboratory procedures performed regarding samples, equipment and documentation. 
• Review all pharmacy procedures performed regarding supplies, shipping and dispensing records, product accountability, adequate supply and replacement and blinding and randomization processes.  
• Verify the site is collecting accurate and credible data (ALCOA); and 
• Assess study and site management verifying activities are properly documented and complete and accurate records. 

QUALIFICATIONS:

ESSENTIAL:

• Bachelor’s degree in sciences (Biological, Nursing) in a relevant field; Masters is an added advantage. 
• Minimum 5 Years with 3 Years’ experience at Supervisory level 

DESIRED: 

• Accreditation as a Clinical Research Associate or similar certification 
• Demonstrate a working knowledge of GCP guidelines; 

COMPETENCIES:

• Demonstrate high levels of integrity and confidentiality 
• Excellent interpersonal, written, presentation and communication skills 
• Good analytical, problem solving and critical thinking skills. 
• Teamwork and ability to work with diverse teams 
• Strong Flexibility, adaptability, multi-tasking and attention to detail 
• Strong team coordination and Supervisory skills.