Training Programme on Clinical Research & Development, 11/00

The Special Programme for Research and Training in Tropical Diseases (TDR) and SmithKline Beecham Biologicals (SB Bio) invite African nationals from malaria endemic countries, working in the developing countries to apply for a 12-month training programme scholarship on Clinical Research & Development. The training involves attendance to Good Clinical Practice (GCP) workshops, vaccinology seminars, clinical study management working groups and on the job practice in clinical study management and clinical development of vaccines. The trainee will be involved primarily in all aspects of clinical development of candidate malaria vaccines.

Summary of the Training Programme

1. Clinical Study Management at SB Bio (Rixensart, Belgium)

Within the context of the Clinical R&D team, the trainee will be involved in activities related to:

* Study preparation: study design, specific protocol summary (SPS)/

protocols, case report form and logistics;

* Conduct of centrally monitored studies: pre-study contacts, study

initiation, monitoring;

* Study reporting: data validation, study report;

* Administration and documents: filing, tracking, financial agreement

* Contacts, co-ordination, working in the presentation: clinical operations group, clinical R&D, other SB Bio departments, international SB departments, investigators, audit;

* Propose and implement the Clinical Development Plan;

* Manage budget, resources needed and timing;

* Knowledge development: literature review, attendance at scientific meetings, clinical trial methodology, FDA/ICH requirements, new technologies.

2. Product Research and Development at WHO/TDR (Geneva, Switzerland)

During a final period of one month the trainee will familiarise her/himself with technical and administrative processes of soliciting, reviewing and funding R&D proposals, with emphasis on clinical research and development. The trainee will follow closely the activities of the clinical coordinator of the Product Research and Development Unit and staff of the Research Capability Strengthening Unit. The training will involve the overview and follow-up of activities related to TDR drug and vaccine development.

Eligibility

African nationals from a malaria endemic country working or involved in the Ministries of Health, academic or research institutions and from those just finishing post-graduate programmes abroad. Preference will be given to candidates under 35 year old, holding an advanced degree in the field of natural sciences (MSc/PhD). Computer skills (MS Word, Excel) are required. In addition, an MD degree would be an asset. English and French mother language candidates are eligible, but working knowledge of English is required.

The following documents should be sent to the address given below (no application forms are required).

1. Full name in capital letters with the family name underlined.

2. Date of birth and nationality (please include photocopy of information page of passport or other identification document).

3. One recent passport sized photograph.

4. Name, address, telephone number, fax number and e-mail address of institution where the applicant is employed.

5. Educational qualifications, including place of study, date of conclusion and grade obtained (transcripts and photocopies of qualifications are not required but may be requested later).

6. A brief description of the applicant's current post and of the post held immediately before (1 page).

7. A description of the applicant's current work/research interests (1 page maximum).

8. A list of the applicant's publications and other abstracts or presentations.

9. A letter of recommendation from two senior scientists/professors that includes their address, telephone numbers, fax numbers and email addresses. (Please include these with the application).

10. An endorsement from the Director of the applicant's home institution testifying to the ability of the applicant to undertake successfully the training proposed and certifying that the applicant, if selected, will be granted a leave of absence. The Director should also indicate how the proposed training will strengthen the institution capability to conduct clinical research upon the return of the trainee.

Applicants from countries requiring national endorsement should submit their applications through proper government channels. A copy of all applications should be sent to the WHO Representative's Office in their home country for information purposes.

All applications must be received by 30 November 2000 at the following address:

Dr Fabio Zicker

Special Programme for Research and Training in Tropical Diseases

World Health Organization

1211 Geneva 27, Switzerland

Tel: +41-22-791-3805

Fax: +41-22-791-4854

mailto:zickerf@who.ch

Additional information can be obtained from

Dr. Nadia G. Tornieporth

Associate Director

Clinical Development

SmithKline Beecham Biologicals

89, rue de I'Institut

B-1330 Rixensart, Belgium

Tel: +32-2-656-8974

Fax: +32-2-658-8132

mailto:Nadia.Tornieporth@sbbio.be

-Applicants will be informed of the outcome in February 2001. Interviews conducted in December 2000 - January 2001. Training activities are scheduled to initiate in May 2001.

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