[Closing date: 15 July 2016]
Overall purpose of the job
– To assist the trial coordination team in monitoring DNDi clinical trials within the region according to Good Clinical Practice (GCP) standards, with regards to the specific duties set out below, to a mutually agreed timetable and at places and dates agreed with the Clinical Project Manager.
– Reporting to the Clinical Project Manager- Paediatric HIV Project
Main duties and responsibilities
- Monitor clinical trial sites as assigned, ensuring compliance to GCP, protocols and applicable regulations.
- Clearly communicate with the sites the findings of the monitoring visits and follow up on pending issues.
- Maintain the sponsor’s trial master files, ensuring their completeness and consistency with the corresponding investigators’ site files.
- Support Clinical Trial recruitment efforts with the DNDi team and the site teams.
- Support and respond to requests from trial site team members and country PIs on trial related matters.
- To be familiar with pharmaceutical regulatory requirements, documentation and processes within the region.
- Provide departmental support for coordination office duties e.g. logistics and trainings.
- Liaise with DNDi Africa Regional Office Project Coordinator, Finance & Administration department, Data Management Team for trial related activities as required.
- Perform other duties as may be assigned.
Skills & qualifications
- Qualified Monitor with at least 2 years’ experience in clinical research monitoring
- Mastery of ICH/GCP
- Complete fluency in written and spoken English
- Able to work alone and unsupervised in an organized and professional manner and with financial integrity
- Good interpersonal, people and time management skills
- Problem solving, attention to detail and helpful approach
- Willingness and flexibility to travel as required
- Shares DNDi’s mission and vision
Terms of employment
Salary will be commensurate with skills and experience and in line with DNDi remuneration scales.
Contract is 2 years, renewable by mutual agreement and subject to exemplary performance, 3 months probation, notice period 1 month.
Applications are due not later than: 15th July 2016 and should be sent to:
HR & Administration Officer
DNDi Africa Regional Office
P.O. Box 21936-00505, Nairobi, Kenya
Applications should include the following:
- Letter of application supporting your candidature
- Current Curriculum Vitae listing names of three references with contact details (telephone and email)
- Your contact telephone number
Expected start date: Preferably immediate
Note: Local contract (no expatriate treatment)