[Closing date: 4 September 2015]
DNDi Africa was established in 2003, and is based at the Kenya Medical Research Institute (KEMRI) Headquarters in Nairobi, Kenya. This regional office conducts R&D projects in the region, including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, and others. It also leads capacity building projects through multi-country research platforms.
The Africa office is seeking to recruit a suitable candidate for the following vacant position
Position: Project Coordinator
Reporting to: Clinical Trial Manager, Nairobi & Clinical Manager, Geneva – for HIV study
Supervises: Clinical Research Associates.
Overall purpose of the job:
- Will be the lead person for paediatric HIV study.
- Coordinating the clinical trials and studies sponsored by DNDi according to Good Clinical Practice (GCP) standards, according to the specific responsibilities set out below under the direction of the and Clinical Trial Manager (CTM) and the Director of DNDi Africa Regional Office, Nairobi
- Carrying out the specific requests of the CTM at the trial sites in relation to any of the trial activities as requested.
- Submitting the required documentation and reports in a timely fashion and to an agreed format
- Attending meetings associated with the project at times and places as requested.
Main duties and responsibilities:
Review of monitoring reports and identifying and resolving issues identified during the monitoring visits
Provide backup, support and advice for trial monitors including co-monitoring and substitute monitoring as and when required
Prepare weekly project status updates and monthly report of trials activities and issues for DNDi Project Management in Geneva / trial coordination office and DSMB Chair.
Provide backup for the clinical trial manager for Serious Adverse Events (SAE) reporting
Provide liaison and support for trial data management centre particularly Trial Statistician and Data Managers
Liaise with DNDi Africa office Regional Operations Manager for trial related activities and payments
Support and respond to requests from trial site team members and country PIs on trial related matters
Arrange trial specific training for trial site teams
To participate in preparing regulatory documentation for conducting clinical trials (submission and approval of protocols), registration of trial medication and protocol amendments.
Supervise the Clinical Research Associate(s)
Prepare and review as appropriate, scientific documents, reports to be used in clinical trials or submitted to Ethics Committee/Regulation authorities.
Setting up clinical trial sites
Perform other duties as may be assigned
Skills & Qualifications
Medical Doctor. Postgraduate training would be an added advantage
- Proven track record in clinical research management.
- At least 3 years recent experience of clinical trials and GCP as investigator/monitor /trial manager
- Complete fluency in written and spoken English
- Able to work alone and unsupervised in an organised and professional manner and with financial integrity
- Good interpersonal, people and time management skills
- Problem solving and helpful approach
- Willingness and flexibility to travel as required
- Shares DNDi mission and vision.
- Experience conducting HIV related studies will be an added advantage
Terms of Employment:
- The position is full time based in Nairobi with frequent travels locally, regionally and internationally
- Excellent salary commensurate with skills and experience and in line with DNDi Africa remuneration scales.
- Contract is 2 years, renewable by mutual agreement and subject to exemplary performance, 3 months probation, notice period 2 months.
- Preferred start date: 5th October 2015 or earlier
Applications are due no later than 4 September 2015 (Deadline Extended) and should be sent via email to:
Regional Operations Manager
DNDi Africa Regional Office
Kenya Medical Research Institute
Applications should include the following:
- Application letter explaining why you are applying for this post
- Current Curriculum Vitae listing names of three references with their contact details (Telephone and E-mail)
- Contact Telephone Number
- Certificates and Diplomas or transcripts to be available during interviews