The African Malaria Network Trust (AMANET) is a not for profit non-governmental organisation registered as a Trust under Tanzania Law. The goals and objectives of AMANET broadly focus on accelerating development of a malaria vaccine through sponsorship of malaria vaccine trials in Africa.

AMANET is currently coordinating a consortium of seven partners in the development of the candidate vaccine and hereinafter referred to as the GMZ2 Consortium. Members involved in this consortium includes the Statens Serum Institute (SSI) in Denmark; UKT University of Tübingen in Germany; Medical Research Council Laboratories in The Gambia (MRC); Medical Research Unit at the Albert Schweitzer Hospital in Gabon (MRU-ASH); Makerere University, Kampala in Uganda (MUK); the Centre National de Recherche et de Formation sur le Paludisme in Burkina Faso (CNRFP), and the coordinating institution- African Malaria Network Trust (AMANET) in Tanzania. This consortium is working on an Integrated Project (IP) funded by the EDCTP, titled “Fostering research capacity, networking and project management through phase I-IIb clinical trials of candidate malaria vaccine GMZ2”. In this IP a baseline study for malariometric indices followed by a multi centred GMZ2 malaria vaccine trial will be conducted in the four participating African countries.

AMANET is seeking an African based CRO to offer clinical monitoring services in order to ascertain that the trial data is high-quality and that participant protection standards are upheld. Local knowledge about regulatory requirements for the Burkina Faso, Gabon the Gambia and Uganda would be an asset, as it provides experience with monitoring activities in these or similar.


SCOPE OF WORK

These terms cover clinical monitoring services for multi centred GMZ2 phase IIb malaria vaccine trial to be conducted in CNRFP Burkina Faso, MRU-ASH Gabon, MRC Gambia, and MUK Uganda. The exact location of trial sites is Banfora in Burkina Faso; URR in The Gambia; Lambaréné in Gabon; and Iganga in Uganda. Clinical monitoring visits entailed under these terms shall be carried out  in accordance with and as defined in  the approved GMZ2 phase IIb paediatric clinical trial protocol (CTP). 

Each site shall by the end of the trial receive 5 visits. A total of 20 visits will be required for all the participating sites. Each visit will require approximately 6 days including travel days.



The CRO should provide a minimum of four qualified and experienced clinical monitors. We require an extra monitor to specifically cater for vaccine accountability in order to maintain blinding.

The monitors will include the following:

• To comprehensively study and understand the allocated clinical trial documents.
  
• To jointly with the GMZ2 consortium develop and implement a comprehensive clinical trial monitoring manual which will include a monitoring plan in collaboration with the clinical trial sponsor and the Clinical Trials Work Package Leader (WP2)
  
• Train and abide with the CTP and the AMANET SOP for monitoring and reporting trial progress
  
• To be available in a timely manner, for the agreed/planned monitoring visits in accordance with the trial site specific calendars
  
• To remain accessible in between the monitoring visits
  
• To be available for telephone contacts and provide on ongoing support to the PI and Local Safety Monitors
  
• To ensure compliance with ICH-GCP in the conduct of the clinical trial
  
• To ensure uniformity of monitoring activities across the four trial sites
  
• To provide detailed and timely reports in accordance with the AMANET SOPs.
  

Application procedure

The deadline for application is 1st March, 2010. The CRO chosen is expected to begin activities around 1st April, 2010. Interested CROs should provide the following

1. One page letter with brief description of the CRO including their experience
   
2. Brief curriculum vitae of monitors to be used for trial if selected
   
3. Quotation for the services above
   
4. Evidence of accreditation for this particular competency
   

Application should be submitted to:

The Managing Trustee,

African Malaria Network Trust (AMANET),

302 Ring Street, Off Rose Garden Road,

Mikocheni A,

P. O. Box 33207,

Dar Es Salaam, Tanzania.

Tel: +255 (0)22 2700018

Or by email to info@amanet-trust.org