Research Clinician HIPC at Medical Research Council

Job Description
Introduction:

• Established in 1947, the Medical Research Council Unit 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 global health priorities and consequent international funding opportunities the current research portfolio of MRC Unit The Gambia is organized under three themes: Vaccines and Immunity, Disease Control & Elimination and Nutrition.  Cross-cutting these themes are research in Maternal and Neonatal Health and an expanded research focus across West Africa.  Non-communicable diseases, particularly those which are infection-related, are another area of work which is expected to expand.  These themes have been selected to target national health needs, to reinforce sub-regional and international links and to address some of the major priorities of the post-2015 Sustainable Development Agenda.
• The Unit has an established clinical trials support office (CTSO) and a research governance manager who provide advice on the conduct of clinical trials and other clinical research and who provide professional leadership and training.  This includes support to address the current regulatory environment in relation to Good Clinical Practice, the regulatory requirements in The Gambia, the EU Clinical Trials Directive and other internationally recognised standards for clinical trial conduct.  The research governance manager also oversees the clinical trial sponsorship responsibilities taken on by The Unit.    
• We are currently engaged in an ongoing series of clinical vaccine trials ranging from phase 1 (including first-in-child and first-in-infant cohorts) to phase 4 trials of various sizes, designs and endpoints. The majority of trials are investigator-led and internally-sponsored by the MRC Unit The Gambia although we also work with other non-commercial and, on occasions, commercial sponsors. 
• Recent trial have predominantly been undertaken in the Western coastal region of The Gambia at established clinical trial facilities within the compounds of government health facilities although future trials will also be undertaken in other parts of The Gambia and also potentially further afield.
• Many infections in young children and babies can be prevented by giving vaccines to young babies, as we already do within the Expanded Programme on Immunisation (EPI). However, many babies around the world still die every year from infections. If we wish to make new vaccines to change this situation, we need to better understand how babies’ bodies defend themselves against infections.  In the last few years, laboratory tests including omic methods have become available which allow us to have a much closer look at how the bodies’ protection works. These new tests work with blood volumes small enough for us to take from newborns and little babies. For this study along with our partners we are using these omic methods to measure how EPI vaccines together protect babies. The knowledge gained from this study may contribute to making better early child vaccines in the future.

Grade:

• Grade 2 - 30 - 32 points according to experience and qualifications. Candidates with their FWACP Part 2 or equivalent, would be Grade 2 - 32 points.
• Candidates with a directly relevant higher degree or with very significant clinical vaccine trial research experience at least comparable to either of the above might be considered for the higher point (32 points)

Purpose of the Job

• To undertake or oversee all aspects of the study including informed consent, assessing eligibility, collection of all data required including safety data, completion of documentation and supervision of the field team according to study protocol.
• To provide clinical assessment and care to study participants presenting with adverse events.

Role
The post-holder will:

• Ensure that study objectives and methods are explained in an appropriate language to potential study participants and/or guardians as applicable, and informed consent is obtained prior to enrolment.
• Motivate, supervise, train and monitor the work of field team on a daily basis to ensure that recruitment, clinical assessment, care, and follow-up of study participants and collection of data and samples are taken accurately, according to protocol and in a timely fashion. .
• Strictly adhere to GCP guidelines, study protocol and MRCG safety manual at all times. Ensure that confidentiality is maintained in the collection and handling of information.
• Conduct the clinical assessment, investigation and care of study participants as may be required.
• Monitor treatment, progress of study participants if admitted for in-patient care.
• Undertake verbal autopsies if necessary to ascertain the cause of death of study participants, if any.
• As part of the recruitment procedures for this trial the clinician will need to provide on-call cover at night and at weekends to recruit participants and to assess any study subject who becomes unwell out of hours.
• Work on the Clinical Services on-call rota and provide clinical support in the MRCG Outpatients Department on a rota basis and within the confines of the work commitment required by the trial.

Relationships:

• The post-holder will be a full-time member of the MRC staff.
• The post-holder will report to Dr. Olubukola Idoko, Clinical Trial Coordinator.
• The theme Leader for the Vaccines and Immunity Theme and PI for the study is Professor Beate Kampmann.
• The Unit Director is Professor Umberto D’Alessandro.
• The Director of Operations is Mr Joan Vives Tomas.

Appraisals:

• Appraisals are held at least annually.

Length of appointment:

• The appointment is for 2 years in the first instance and is subject to a probationary period of 6 months.

Any other duties:

• To perform any other duties consistent with the remit of the post.

Person Specification
Essential:

• MBBS or equivalent.
• Experience of staff management
• Excellent written and spoken English
• 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 organizational skills
• Willingness to be on-call and work outside the normal working hours

Desirable:

• Practical experience of health research in developing countries
• Previous experience in conducting clinical trials according to ICH-GCP
• Clinical paediatric experience
• Record of publications in peer-reviewed journals
• Part 1/2 of FWACP or equivalent in paediatrics
• Postgraduate qualifications (Masters, Doctoral level)
• Excellent IT skills (Microsoft Word, Excel, Access).