Clinical Research Exploration Consultant - United Kingdom - Company limited

Description

Clinical Research Exploration Consultant

MSF's Manson Unit wishes to capitalise on the experience of MSF's PragmaticClinicalTrial for a more Effective, Concise, andLess toxic MDR-TB treatment regimen - TB-PRACTECAL, (TB-P), specifically on its success in:

• creation of strong, context-specific evidence for health programming decisions, strengthening strategic partnerships,
• impacting new clinical research practices
• increasing our influence in the field of pharmaceutical justice and access to healthcare products

MSF's Vienna Evaluation Unit's evaluation of TB-P assessed that the trial enabled development, definition, and diffusion of new regimen within the research community through establishing:

• pragmatic research approaches in complex settings,
• clinical research partnering,
• research impact planning,
• multi-year project planning,
• multidisciplinary sub-study integration and patient centred care (PCC) for research.

Gap analysis

Despite conducting TB-P we are yet to develop clear procedures to review opportunities for clinical research and trial support, and to how to advance them to effective completion.

Aim

To enable MSF to create high-quality context specific clinical evidence to support our medical mission, including improving clinical practice and access to healthcare products.

Objectives

To address the process and systems gap identified namely:

• Identify a pathway and develop a process for review of clinical research opportunities.
• Develop a model of support with standard operating procedures to comprise of:
• planning, protocol generation and adaptation (including integration of sub-studies), analysis, recording and implementation of clinical research within MSF.
• the uptake and dissemination of clinical research within academic and policy audiences and impacted populations
• Identify potential strategic links for research in MSF (all stages of research pathway)

Expected Outcome

MSF will have a process to review opportunities for clinical research and trials and a flexible/adaptable model of clinical research support allowing us to maximise the opportunities available.

Deliverables and Deadlines

• A defined pathway and process for assessing clinical research and trial opportunities for MSF (whether originating internally or externally)
• Potential model(s) of clinical research and trial support including partnership (internal and external) which should be context and thematically flexible.
• Recommendations for how the model(s) can be tested.
• An analysis of strategic links (internal and external) for research in MSF from ideation to dissemination and impact realisation, e.g. Drugs for Neglected Diseases Initiative (DNDi), Epicentre, Global Antibiotic Research & Development Partnership (GARDP), Clinical research and trial networks, policy actors amongst others.

Depending on the success of the consultation; there is potential for a follow up consultancy.

Profile of consultant

• Masters' degree or equivalent experience in a biomedical/scientific or allied field.
• Demonstrable knowledge of working in clinical research and trial design implementation within the humanitarian health sector, and an academic clinical research setting.
• Significant experience in performing study assessments and analysis, specific to needs for clinical research and trials.
• Knowledge of clinical trials and clinical research and their associated regulations and set up requirements.
• Ability to work collaboratively with trial networks and operatively in a cross-cultural setting with long-distance working relationships.
• Understanding of the challenges humanitarian health sector and how to provide support to MSF or similar research systems.
• Previous exposure in clinical research phases.
• Demonstrable experience on setting up interdisciplinary team for research design and implementation.
• Technical clinical research experience.
• Capacity to work autonomously.
• Excellent oral and written communication skills.
• Project management experience and knowledge.
• Assumptions made, questions or areas of uncertainty.
• Examples of previous work- give a summary of similar work that you have developed and delivered before- what worked well? what lessons you learnt?
• Your CV (or those you propose to deliver the project)