Clinical Trial Coordinator / Clinician (Malaria Vaccine Trials) at Medical Research Council

Location: Fajara, Gambia
Department / Division: Research Support Office
Grade: 2 - 35 Points
Length of appointment: The appointment is for 1 year (with possible extension to 3 years) and is subject to a probationary period of 6 months.

Introduction

• The Medical Research Council Unit The Gambia is one of the largest scientific research centres in sub-Saharan Africa, with an international reputation for ground-breaking research into some of the leading causes of morbidity and mortality in the tropics.
• Our overall goal is to improve the health of people in developing countries by aiming for excellence in research, healthcare and training.
• Our research program spans basic scientific research, clinical studies, epidemiological studies and intervention trials, and translational research.
• The field and laboratory-based work draws on excellent research and clinical facilities and attracts international funding.
• To reflect changes in national and global health priorities and new international funding opportunities a new research portfolio has been organized under three themes:
  • Disease Control & Elimination;
  • Vaccines & Immunity; Nutrition &
  • Planetary Health.
• These themes have been selected to target health needs of low- and middle-income countries, to reinforce sub-regional and international collaborations and to address some of the major current priorities in the Sustainable Development Goals.
• The Unit, led by Professor Umberto D’Alessandro, receives an MRC core investment grant every 5 years, following the review of past activities and future plans.
• In addition, all research activities are supported by external grants from a variety of sources.
• The Unit has a turnover of more than £22m per annum and employs about 1,400 staff.
• The Unit has a Clinical Trials Unit 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.
• The post-holder may be based at MRC Fajara or elsewhere in The Gambia according to the needs of ongoing trials.

Purpose of the Job

• To support the Principal Investigator (PI) in all aspects of the management of the study and assume partly responsibilities of the PI when delegated
• To be a focal point for communication with the sponsor and study team.
• To oversee the development of study specific procedures and other trial documents required for trial conduct and to provide input into protocol development when required.
• To oversee the daily conduct of the study at the trial sites.
• To ensure the rights and safety of trial participants are maintained as paramount by all trial staff
• To oversee the quality and consistency of all trial data entered into CRF/eCRF as specified in the study protocol and relevant study specific procedures
• To oversee the training and supervision of the trial team staff including research clinicians, nurses, field workers, clinical trial officers, laboratory and data personnel
• Work in partnership with the Clinical Trials Unit
• To maintain the trial master file/investigator site file

Role
The post-holder will:

• Know, understand and follow the study protocol at all times
• Establish appropriate procedures required for effective running of the clinical trial such as study specific procedures and source documents.
• Ensure that study objectives and methods are explained adequately to the clinical trial team and train nurses and field workers in the conduct of the study.
• Manage the study staff and motivate, supervise and monitor the work of the clinical trial team on a daily basis to ensure that recruitment, clinical assessments, medical care and follow-up of study participants are conducted smoothly and that collection of data and samples are taken accurately according to protocol and in a timely fashion.
• Ensure that the trial is conducted strictly according to ICH-GCP guidelines with respect to quality and ethics including confidentiality.
• Oversee the review of all source data before entry into the dedicated database and follow-up queries.
• Monitor the conduct of the trial by reviewing the assessment of clinical and safety data.
• Coordinate the work of the clinical and laboratory study team
• Undertake all work strictly following the safety guidelines as laid down in the MRC’s Safety Manual.
• Manage the trial master file in conjunction with the PI
• Provide limited clinical services at the study health centres or MRC clinic, when feasible in accordance with the required work for the trial.
• S/he will oversee the daily conduct of the study, supervise the data entry into the CRF/eCRFs, supervise the study team of Clinicians, Nurses and Field Workers.
• S/he will be the focal point for communication with the study team.

Relationships:

• The post-holder will be a full-time member of the MRC staff.
• The post-holder will report to Prof Umberto D’Alessandro, the PI of the trial, or to Dr Annette ERHART, co-PI and Malaria Research Coordinator at the MRC Unit;
• The Unit Director and Theme Leader for the Disease Control & Elimination Theme is Professor Umberto D’Alessandro.
• The Director of Operations is Dr Davis Nwakanma.

Appraisals:

• Appraisals are held at least annually.

Any other duties:

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

Person Specification
Education and Training - minimum requirements:

• MB BS or equivalent medical qualification
• FWACP or comparable Masters Level training in the field of clinical trials and/or vaccinology or comparable clinical trial hands-on experience
• Previous work on clinical trials of drugs/vaccines following GCP requirements
• Experience of clinical vaccine trials in a relevant setting
• Practical experience of health research in developing countries
• 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
• Excellent organisational skills
• Excellent IT skills (Microsoft Word & Excel, in particular)
• A team player and motivator
• Willingness to be on-call and work outside the normal working hours.

Desirable:

• Record of publications in peer-reviewed journals
• Ability to work on databases and statistical packages.

Experience & Job related knowledge:

• Previous work on clinical trials of drugs/vaccines following GCP requirements
• Practical experience of health research in developing countries
• Experience of staff management
• Excellent written and spoken English

Abilities & Aptitudes:

• Commitment to working in a multi-disciplinary team
• Enthusiastic and committed team player and team motivator
• Excellent interpersonal and verbal/written communication skills
• A flexible and well-organized approach to work and an ability to meet deadlines
• Attention to details
• Excellent organizational skills

Other:

• Willingness to be on-call and work outside the normal working hours.

Preferred:

• Ability to work on data bases and statistical packages
• Record of publications in peer-reviewed journals
• Excellent IT skills (Microsoft Word, Excel, Access).

Remuneration

• The salary will be on Grade 2, 35 Points of MRCG at LSHTM’s pay scale.
• A minimum net monthly salary of 95,000 Dalasi is on offer. This equates to 1,860 USD approximately per month using the prevailing Dalasi / USD exchange rate.
• Please note that the salary will be paid in Dalasi and that the USD figure quoted is only given as a guide.
• For displaced staff the package will include rent-free furnished accommodation, flights, displacement allowance for spouse and children, contribution to school fees for children and shipment of personal effects.