Quality Control Officer KMR8 at KEMRI Wellcome Trust Research Programme (KWTRP)

Vacancy No: CGHR/121/01/20
 
Project description: The Spatial Repellent (SR) project is funded by UNITAID and seeks to fill the gaps for assessing spatial repellent products efficacy, deployment and uptake strategies. In this regard, Kenya has been selected as the site for conducting the epidemiological evaluation of spatial repellent product efficacy in a high malaria transmission setting. This study will be conducted in Busia County over the next two years. The project seeks to fill the following position(s).  
 
Location: Busia County

Reports to: QA Officer
 
Essential Requirements:
 
Diploma in Nursing, Clinical Medicine or Medical Laboratory At least two (2) year working experience in performing QA/QC in a busy clinical trial Have a good working knowledge of GCP requirements for clinical trials. Should have experience working with MS suite (MS Word, Excel and Power point) Licensed motorcycle rider is an added advantage.
 
Desired Qualities:

• Fluency in English and Kiswahili- both written and oral.
• Excellent communication skills; ability to work well individually, in a team, with the public and to collaborate with counterparts.
• Specialized training in research ethics.
• Attention to detail and systematic approach to their work.
• Previous experience preparing study documents such as SOPs and CRFs
• Proven leadership skills, assertiveness, and ability to take initiative and work in study sites

Position Description: The Quality Control Officers will report to the QA Officer and will be responsible for ensuring that the data collection and filling work (both paper and electronic) is conducted as per the SR study protocol and GCP standards. S/he must be flexible and work within the existing structure, in a professional and ethical manner with competence, accountability and integrity. His/her functions shall not be limited to the following;
 
Specific tasks and responsibilities:
 

• Monitor study team compliance with required study procedures and GCP standards.
• Assess and ensure subject safety throughout participation in trial.
• Assist in monitoring and documenting adverse events.
• Ensure that the chain of custody of the Study ICF and samples are well maintained.
• Review all participant files for accuracy and ensure specific visit on CRF are completed as per GCP standards.
• Perform QC review of all microscopy result forms.
• Assist component leads to resolve QC queries and record discrepancies identified during reviews.
• Accurately and timely report the problems requiring action from the study component lead, Regulatory Officer and the PI.
• Ensure that the ICF is complete and according to GCP standards.
• Performing quality control checks on source documents.
• Writing and reviewing of study Standard Operating Procedures.
• Developing of study source documents
• Any other duties assigned by the Regulatory Officer.

Terms of Employment:

Six (6) Months contract as per KEMRI scheme of service with a possibility of extension.

Remuneration:

Compensation is negotiable within a relevant grade, based on education levels, relevant experience and demonstrated competency. The Salary scheme is based on the KEMRI scales plus supplemental amounts.