MRC UNIT, THE GAMBIA
JOB DESCRIPTION
CLINICAL TRIAL
Research Clinician
Multidose Vial
Pneumococcal Conjugate Vaccine Trial
1.
Job Title:
Research Clinician
2.
Introduction:
Established in 1947, the Medical Research Council in The Gambia has an international
reputation for ground-breaking research into some of the leading causes of morbidity
and mortality in the tropics. Achievements include a large trial showing the efficacy of
Haemophilus influenzae type B vaccine in The Gambia and the subsequent near
elimination of the disease, pioneering studies of the impact of insecticide treated bed
nets as a preventive measure against malaria leading up to their worldwide use,
studies demonstrating the impact of conjugate pneumococcal vaccines on pneumonia
and child mortality and the demonstration of a dramatic reduction in the carriage of
Hepatitis B in The Gambia due to the effects of vaccination.
To reflect changes in national and global health priorities and new international funding
opportunities a new research portfolio has been organized under three themes: Child
Survival; Disease Control & Elimination; Vaccinology. These themes have been
selected to target national health needs, to reinforce sub-regional and international
links and to address some of the major current priorities in the Millennium Global
Health Goals.
The Unit established a clinical trials support office (CTSO) to conduct and advise others
on the conduct of clinical research, to provide professional leadership and training in
clinical trials, including support to address the current regulatory environment in
relation to Good Clinical Practice and the EU Clinical Trials Directive.
We are undertaking a trial to evaluate the safety, tolerability and immunogenicity of a
multi-dose vial for Pneumococcal Conjugate Vaccine (MDV PCV13). The results of the
trial will be presented by the sponsor to regulatory authorities for imminent vaccine
licensing. We are seeking two Research Clinicians with experience on Clinical Trials in
Developing countries to lead Clinical activities of the trial in a Health Center situated
within an area of 20 Km from the main station in Fajara, West Gambia.
3.
Grade:
Occupational Group E1.
4.
Purpose of the job:
To coordinate the daily conduct of the trial at the trial site.
To coordinate clinical activities related with the trial, including clinical evaluation of
study participants, follow-up and assess and management of AE/SAEs.
To supervise the field work according to study protocol.
To provide up to date research activities and liaise with the sponsors, local trial and
safety monitors.
5.
Role:
The post-holder will:

Know, understand and follow Study Protocol at all times.

Coordinate transport of study vaccines to the corresponding Health Centres and
return to Fajara.

Strictly adhere to GCP guidelines. Ensure that confidentiality is maintained in
the collection and handling of information.

Ensure that study is explained in an appropriate language to guardians of study
participants, ensure their comprehension of the information and be present
when the informed consent is signed/thumbprinted.

Conduct the clinical assessments and investigations of and provide medical care
to study participants as required.

Coordinate randomization activities for the study in the Health Centre.

Coordinate vaccination activities of study participants (EPI vaccines as well as
Investigational Product)

Complete study forms and questionnaires following standard procedures.

Assess and manage AE and SAEs for study participants during the trial period.

Monitor treatment and progress of study participants if admitted for in-patient
care.

Motivate, supervise and monitor the work of Field Workers on a daily basis to
ensure accurate recruitment, clinical assessment, care, and follow-up of study
participants and that collection of data and samples (blood) are taken
accurately, according to protocol and procedures in a timely fashion.

Assist in training study Field Workers.

Provide clinical services at the study Health Centres or MRC clinic when
indicated and feasible according to the requirements of the study.

Undertake all work strictly following the safety guidelines as laid down in the
MRC’s Health and Safety Manual.

Provide limited clinical services at the study health centres or MRC clinic, when
feasible in accordance with the required work for the trial.

6.
Relationships:
i. The post-holder will be a full-time member of the MRC staff.
ii. The post-holder will report to the Clinical Trials Coordinator
iii. The PI of the trial is Dr Anna Roca.
iv. The Theme Leader for Vaccinology is Professor Beate Kampmann.
v. The Unit Director is Professor Tumani Corrah.
vi. The Director of Operations is Mr Peter Noble.
7.
Appraisals:
Appraisals are held at least annually.
8.
Length of appointment:
The appointment is for 18 months and is subject to an initial probationary period of 6
months.
9.
Any other duties:
To perform any other duties consistent with the remit of the post.
PERSON SPECIFICATION
Research Clinician
1.
Education and Training – minimum requirement
Paediatrician (Part 1 FWACP or equivalent)
2.
Experience & job related knowledge
Practical experience of health research in developing countries
Previous experience in conducting clinical trials
Experience of staff management
Excellent written and spoken English
3. Abilities & Aptitudes
Commitment to working in a multi-disciplinary team
Excellent interpersonal and verbal/written communication skills
A flexible and well-organized approach to work and an ability to meet deadlines
Attentiveness to detail
Excellent organisational skills
4.
Other
Willingness to be on-call and work outside the normal working hours
5.
Preferred
Record of publications in peer-reviewed journals
Part 2 FWACP
Excellent IT skills (Microsoft Word, Excel, Access)