Call for Applications for an Independent Monitor for Clinical Trials for the icipe–German Doctors-funded “Phase IIa Randomised Controlled Trial of a Locally-Made Herbal Remedy (Neem and Coconut Oil) for Treatment of Jiggers (Tunga penetrans)”
The International Centre of Insect Physiology and Ecology (icipe) is interested in contracting an Independent Monitor for the Phase IIa randomised controlled trial of a locally-made herbal remedy (neem and coconut oil) for treatment of jiggers (Tunga penetrans) in Kenya.
Opportunity closing date: 18 November 2016.
Tungiasis, a parasitic skin disease (sand flea disease), inflicts pain and suffering on millions of people in sub-Saharan Africa and South America; yet, it gets little attention from donors, scientists, governments and even health workers. There is no effective, available, safe and simple treatment. Instead, communities in their desperation remove the embedded fleas using unsterilised pins and plant thorns that carry a huge risk of secondary infection with bacteria (and possibly HIV and Hepatitis B). The government of Kenya recommends the use of potassium permanganate and Vaseline; but, in a recent trial, this has indicated only a 39% efficacy. Some communities use their herbal remedies for sand flea control. In Kilifi County, local community self-help groups are using a mixture of two natural products, neem oil (Azadirachta indica) and coconut oil (Cocos nucifera), known as JIGFIX. Coconut oil is used in the food and cosmetics industry and neem oil as an antiseptic, for medicinal purposes and for agricultural insect pest control. The safety and beneficial properties of these oils has been shown in various contexts, but their combined effect on pathology, bacteria, fungi or insects has never been tested.
The trial objective is to determine whether a mix of neem and coconut oils kills a higher proportion of embedded jiggers in 7 days than the current standard treatment of potassium permanganate and Vaseline.
2. DESCRIPTION OF THE ASSIGNMENT
The expert is expected to act as an Independent Monitor for the Clinical Trial, to ensure adherence to the protocol as approved by KEMRI Scientific and Ethics Review Unit and the Pharmacy and Poisons Board of Kenya-Expert Committee on Clinical Trials.
She/he will report to Dr Ulrike Fillinger during the duration of the consultancy.
3. EXPERT’S PROFILE
Qualifications and skills
- 10 years of experience managing international and local clinical trials for international pharmaceutical companies and academic institutions.
- 6 years of experience as an Independent Monitor for international and local clinical trials.
- Experience planning, implementing and monitoring clinical research projects.
- BSc in Health Sciences, MSc in Clinical Trials.
- Certificate of Good Clinical Practice.
- Membership of recognised clinical trials professional body.
4. STARTING DATE, DURATION AND LOCATION
Duration of the assignment and starting period
The contract will be for a maximum of 10 days. The mission will be carried out between 23 January and 19 February 2017.
- Plan and ensure all study documents comply with ICH GCP.
- Develop Central Clinical Study and Investigator Site File.
- Train site staff in GCP.
- Ensure the trial is conducted in accordance with protocol.
- Source data verification during data collection.
- Site close out.
The expert will be required to provide a report to the sponsor and PPB/ECCT.
HOW TO APPLY:
Send a proposal including a CV in PDF format detailing the services to be provided, proof of previous experience in this area, and a list of three referees to email@example.com by close of business Friday 18th October 2016. On the subject line, indicate “Clinical Trial Monitor for Jigger Trial”.