The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit organization whose main objective is to improve the quality of life and health of people suffering from neglected diseases by using an alternative model to develop drugs for these diseases. DNDi, in collaboration with KEMRI and other Institutions in Africa is currently conducting multi-country and multi-centre clinical trials on Leishmaniasis (Kala-azar).
DNDi/KEMRI is seeking to recruit suitable candidates to fill the following vacant positions both of which to be based in Nairobi with extensive travel within the East Africa region and occasional travel to Europe:
Project Co-ordinator
Overview of the position:
- 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 DNDi Project Manager, Geneva and the Medical coordinator, Nairobi
- Carrying out the specific requests of the Project Manager/Medical coordinator 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.
- A resident African National of one of the four LEAP partner countries participating in the trial. (Sudan, Ethiopia, Kenya, Uganda)
Specific Responsibilities:
- Day to day management of the clinical trial monitors including time-tabling site visits, review of monitoring reports and identifying and resolving issues identified during the monitoring visits
- Chair trial monitors’ meetings
- Provide backup, support and advice for trial monitors including co-monitoring and substitute monitoring as and when required
- Prepare monthly report of LEAP trials activities and issues for DNDi Project Management in Geneva / trial coordination office and DSMB Chair.
- Provide backup for the clinical medical coordinator 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 Finance & Administration 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) and registration of trial medication
- Supervise the Clinical Research Associate(s)
Education:
- Medical Doctor. Postgraduate training would be an added advantage.
Essential Skills/Attributes:
- Proven track record in clinical research management.
- Complete fluency in written and spoken English (working language for all DNDi/PI communications and trial documentation is English)
- At least 2 years recent experience of clinical trials and GCP as investigator/monitor /trial manager
- 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.
Clinical Research Associate
Overview of the position:
- Overall objective is to assist the trial coordination team in managing the logistical aspects of the DNDI/LEAP 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 DNDI Project Manager - Geneva, the Medical Coordinator — Nairobi and Project Coordinator - Nairobi
- A resident African National of one of the four LEAP partner countries participating in the trial. (Sudan, Ethiopia, Kenya, Uganda)
Specific Responsibilities:
- Assist the Project Coordinator in the day to day coordination of the clinical trial monitors including time-tabling site visits, reviewing monitoring reports and identifying and resolving issues identified during the monitoring visits
- Clinical monitoring of trial sites in conjunction with other relevant staff
- Provide liaison and support for trial data management centre particularly Trial Statistician, Data Managers and Data Management Assistants
- Liaise with DNDi Africa office Finance & Administration Manager for trial related activities and payments
- Support and respond to requests from trial site team members and country Pls on logistical trial related matters
- Ensure adequate and timely re-ordering of all trial site supplies, trial medication etc.
- To be familiar with pharmaceutical regulatory requirements, documentation and processes within the region
- To keep appropriate documentation of the trials with regards to logistical data in accordance to GCP
- To participate in preparing regulatory documentation for conducting clinical trials (submission and approval of protocols) and registration of trial medication
- Prepare periodic reports as required
- Maintain an inventory of all equipment and supplies related to the clinical trials sites
- Attend meetings associated with the project at times and places as requested.
Education:
- Bachelor of Science degree with five years experience or MSc with two years experience in clinical trials
Essential Skills/Attributes:
- Proven track record in clinical research management.
- Qualified Monitor with monitoring experience
- ICH/GCP Knowledge
- 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
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, 3 months probation, notice period 1 month. Applications are due no later than: 10th March 2010 should be sent to:
DNDi Africa Liaison Office.
Kenya Medical Research Institute,
Centre for Clinical Research
P.O. Box 20778 00202,
Nairobi, Kenya
Email: africarecruitment @ dndi.org
Applications should include the following:
- Letter of Application
- Current CV with names and contact details (Telephone and E-mail) of three references together and your contact telephone number
- Copies of Certificates and Diplomas or transcripts SHOULD NOT be attached. These will be needed if you are called for an interview
