The Mwanza Intervention Trials Unit (MITU) based at the National
Institute for Medical Research campus in Mwanza, Tanzania is a
collaborative research unit of the London School of Hygiene and Tropical
Medicine and the National Institute for Medical Research. The mission
of the Mwanza Intervention Trials Unit is to contribute to improving
health through the development and evaluation of interventions against
HIV and other health problems by conducting research, including clinical
trials, to the highest international standards; to enhance the capacity
to carry out such research in Tanzania and the East African region; and
to contribute to the translation of research findings into health
policy. MITU is currently collaborating with other international
research partners and the World Health Organization to prepare and
implement a one-year multicentre clinical trial to test the safety and
immunogenicity of a promising vaccine candidate to prevent viral
haemorrhagic fever. The study is being conducted in healthy volunteers.
The Unit is now inviting applications from motivated and suitably
qualified candidates to fill the following position:
1. Quality Officer
The post holder will implement, maintain and monitor the quality system at MITU to ensure that the clinical site’s activities are working in accordance with Good Clinical Practice (GCP), the clinical trial protocol and the standard operating procedures (SOPs)
Key Responsibilities for Post Holder
• Maintain the local quality system as established by the Quality Manager to provide assurance that the clinical site’s activities are working in accordance with GCP, the clinical trial protocol and the SOPs.
• Maintain the document management system to ensure that all SOPs and forms are current and appropriately controlled.
• Coordinate the revision of the clinical trial SOPs to ensure that all procedures are authored, reviewed and approved appropriately.
• Support with the documentation and resolution of any deviation from SOPs or guidelines.
• Support the Quality Manager during an internal audit, external audit and regulatory inspection.
• Ensure that any finding from an audit, monitoring visit or inspection is appropriately addressed within the agreed timeline.
• Perform QC checks on the Investigator Site File at predefined time points to ensure the file is maintained in accordance with GCP and the relevant SOPs.
• Perform QC checks at certain points of the clinical trial process as prearranged with the Quality Manager to check for compliance.
• Maintain key performance indicators for the quality system and provide them at agreed time points to the Quality Manager.
• Escalate to the clinical trial Project Manager and Quality Manager any identified quality issue.
• Act as the local point of contact for any quality system related issue.
• Influence local working practices and continually look to improve standards of quality within the clinical trial activities.
• Weekly meeting attendance and participation.
• Perform any other duties as may be assigned by your supervisor and the Principal investigator
Education and Training
• M.Sc. qualification or equivalent
Experience and job-related knowledge
• A minimum of 2 years experience working in a controlled working environment.
• Ability to meet and comply with international standards that are applicable to working environment.
• Excellent organisation and communication skills, including written and spoken English.
• Experience with documentation writing would be an advantage.
• Experience working with clinical trials or research studies.
• Proficiency using MS Word, Excel and PowerPoint.
Abilities and Aptitudes
• Understanding of the importance of quality assurance, and proactive in anticipating, identifying, and resolving issues relating to working standards;
• Self confident, knowledgeable and comfortable in discussions with senior members of a department or organisation;
• A good communicator with an excellent eye for detail;
• Excellent recording skills, able to support the writing of user-friendly documentation;
• Good planning and organisation skills;
• Pro-active and able to work on own initiative.
Mode of application:
• Letter of application with details of how you meet EACH of the above criteria, suitability for the post and indicating the earliest date for which you would be available to start in this role.
• A daytime mobile telephone number and e-mail contact details.
• Curriculum vitae (CV) including names and addresses of three referees (two must be from your most recent employers).
• Copies of all relevant certificates and memberships and qualifications.
Closing date for applications
• Applications received later than Friday 13th November 2015 will not be considered
• Interviews will be held at the earliest available opportunity and you will be notified by email if you are selected for interview.
• Candidates who are not available for an immediate start in this role will not be considered.
All documents to be sent by email to recruitment@mitu.or.tz
A competitive remuneration package will be offered.
1. Quality Officer
The post holder will implement, maintain and monitor the quality system at MITU to ensure that the clinical site’s activities are working in accordance with Good Clinical Practice (GCP), the clinical trial protocol and the standard operating procedures (SOPs)
Key Responsibilities for Post Holder
• Maintain the local quality system as established by the Quality Manager to provide assurance that the clinical site’s activities are working in accordance with GCP, the clinical trial protocol and the SOPs.
• Maintain the document management system to ensure that all SOPs and forms are current and appropriately controlled.
• Coordinate the revision of the clinical trial SOPs to ensure that all procedures are authored, reviewed and approved appropriately.
• Support with the documentation and resolution of any deviation from SOPs or guidelines.
• Support the Quality Manager during an internal audit, external audit and regulatory inspection.
• Ensure that any finding from an audit, monitoring visit or inspection is appropriately addressed within the agreed timeline.
• Perform QC checks on the Investigator Site File at predefined time points to ensure the file is maintained in accordance with GCP and the relevant SOPs.
• Perform QC checks at certain points of the clinical trial process as prearranged with the Quality Manager to check for compliance.
• Maintain key performance indicators for the quality system and provide them at agreed time points to the Quality Manager.
• Escalate to the clinical trial Project Manager and Quality Manager any identified quality issue.
• Act as the local point of contact for any quality system related issue.
• Influence local working practices and continually look to improve standards of quality within the clinical trial activities.
• Weekly meeting attendance and participation.
• Perform any other duties as may be assigned by your supervisor and the Principal investigator
• M.Sc. qualification or equivalent
Experience and job-related knowledge
• A minimum of 2 years experience working in a controlled working environment.
• Ability to meet and comply with international standards that are applicable to working environment.
• Excellent organisation and communication skills, including written and spoken English.
• Experience with documentation writing would be an advantage.
• Experience working with clinical trials or research studies.
• Proficiency using MS Word, Excel and PowerPoint.
Abilities and Aptitudes
• Understanding of the importance of quality assurance, and proactive in anticipating, identifying, and resolving issues relating to working standards;
• Self confident, knowledgeable and comfortable in discussions with senior members of a department or organisation;
• A good communicator with an excellent eye for detail;
• Excellent recording skills, able to support the writing of user-friendly documentation;
• Good planning and organisation skills;
• Pro-active and able to work on own initiative.
Mode of application:
• Letter of application with details of how you meet EACH of the above criteria, suitability for the post and indicating the earliest date for which you would be available to start in this role.
• A daytime mobile telephone number and e-mail contact details.
• Curriculum vitae (CV) including names and addresses of three referees (two must be from your most recent employers).
• Copies of all relevant certificates and memberships and qualifications.
Closing date for applications
• Applications received later than Friday 13th November 2015 will not be considered
• Interviews will be held at the earliest available opportunity and you will be notified by email if you are selected for interview.
• Candidates who are not available for an immediate start in this role will not be considered.
All documents to be sent by email to recruitment@mitu.or.tz
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