Jobs at KEMRI Wellcome Trust Research Programme (KWTRP)

JOB PURPOSE: 

The overall purpose of this post is to undertake research and clinical trials under the human infection (challenge) platform. This will need to be undertaken under good clinical practice ensuring compliance with regulatory, statutory and programme policies in the performance and conduct of clinical trials, patient management including other related clinical and/or research activities and execution of research studies.

The post holder will be responsible for day-to-day oversight of the clinical trials and clinical research activities, develop research ideas. The post holder will work as clinical lead on the project(s) to ensure safety and clinical care of all study volunteers; contribute to tasks preparatory to the project(s), where applicable, to tasks including developing and submitting protocols, developing study work plans, organising, and conducting training for project-specific staff; and ensure compliance of all study staff to good clinical practices and procedures. The post-holder will aid day-to-day organisation and coordination of the research studies and trials, leading safety monitoring on clinical trials, lead and contribute to protocol and SOP development, and day-to-day supervision of clinical staff. Although these are the primary responsibilities, the post-holder will also be involved in higher level responsibilities for ensuring all clinical activities and procedures are carried out to quality standards, managing, and leading the clinical team whilst expected to share the load and as guided by the PI.

This post is open to qualified doctors with a PhD in a relevant field with research experience and will be funded for a three-year period. The post-holder is expected to develop clinical research methods and to execute programme management as well as roles in data management, sample/specimen management, data analysis, and report writing and scientific dissemination through publication writing and presentations. The post is demanding, involving attention to detail and timescales, and strong engagement with various stakeholders and collaborators.

JOB DIMENSIONS:

The KEMRI-Wellcome Trust Research Programme (KWTRP) conducts high quality research on diseases with the highest burden in developing countries. The programme is recognised internationally within the fields of international public health, clinical tropical medicine, epidemiology, and immunology. The programme aims to maximise opportunities for learning and training to maintain a cadre of highly skilled and experienced staff from all disciplines.

The human infection (challenge) platform currently comprises of conducting clinical trials in two disease areas, malaria and Shigella with the aim of aim of accelerating vaccine development through evaluation of investigational products such as vaccines, identifying correlates of protection and/or correlates of immunity, and understanding of naturally acquired immunity. This involves the deliberate infection of healthy volunteers with infection causing agents (e.g., malaria and Shigella).

The post holder will need to be self-sufficient and be able to work with minimal supervision against demanding yet often unpredictable timelines. The post is mentally demanding and involves a high level of communication. The post holder may also be required to contribute to other linked projects.

The post-holder will be based in Kilifi working within an experienced team and research group.

KEY RESPONSIBILITIES:

• Independently oversee and coordinate all clinical activities according to GCP and protocol requirements.
• Prepare and execute research plans in liaison with other teams including those in the laboratories, data management and international collaborating partners.
• Take the lead in/contribute to study/clinical trial set up, identification of resource requirements, documentation of protocols, staff training, and grading and identification of adverse events etc.
• Work with the clinical team and researchers to provide good quality clinical care of study volunteers.
• Supervise and mentor other study team members, i.e., research medical officers, clinical officers, nurses, etc.
• Ensure that the rights, safety, and welfare of the study volunteers are protected, and clinical trial activities are conducted in accordance with the protocol, GCP and the regulatory guidelines. Ensuring adherence to the clinical SOPs regarding clinical and laboratory investigations of the volunteers in the study.
• Lead the collection, processing, compilation, and analysis of study data/samples and ensure all related records and reports are handled and managed in line with study protocols.
• Prepare, analyse, and present research summaries to Kilifi County public health staff, international collaborators, sponsors and at international conferences and meetings.
• Liaise with data management teams to ensure that all data is entered into relevant databases on time and verified.
• Carry out data analysis and interpretation and provide relevant matrices/ information including statistics, summaries, charts, graphs, reports, presentations etc.
• Prepare and submit draft reports as required including activity reports, project progress reports etc.
• Attend and actively participate in investigator’s meetings and other meetings within the research group, department, and programme e.g., journal clubs/seminars as needed.
• To participate in manuscript preparation, grant development, among other scientific roles
• Support and provide scientific mentorship and supervision of students working in the project.
• And any other duties that may be assigned by supervisors from time to time.

QUALIFICATIONS:

• PhD in a biomedical subject or any other relevant field.
• Bachelor of Medicine and Bachelor of Surgery (M.B;Ch.B.) degree or another related field.
• Upto 4 years Post-Doctoral experience.
• Eligibility for registration with the Kenya Medical Practitioners and Dentists Board .
• Proven record of experience with human subject’s research or demonstrable active interest and/or experience in biomedical research. Work on clinical trials or observational studies is an added advantage.
• Working experience in data analysis and use of statistical analysis software such as STATA or R.
• Significant skills in leadership, organisation, prioritisation, problem solving and decision making.
• Ability to network, communicate, resolving disputes, and maintain good working relationships within a multi-cultural environment.
• Ability to lead and work within a team.

DESIRABLE:

• Training in ICH-GCP.
• Experience/qualification in adult medicine (clinical or research).
• Experience/qualification in basic biostatistics and clinical research.
• 1-2 years’ experience in clinical trials.
• Training in adult life support (basic and/or advanced).
• Current passport and ability to travel for international meetings

COMPETENCIES:

• Demonstrated high levels of confidentiality and integrity
• Excellent interpersonal, written, presentation, and communication skills 
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong Management, leadership, and decision-making skills.
• Ability to build strong and diverse effective teams, delegation, and team motivation.
• Ability to build productive and collaborative relationships with various stakeholders
• Ability to work independently with minimal supervision.

go to method of application »

This post is based at the KWTRP, which is a partnership between the Kenya Medical Research Institute, the Wellcome Trust and the University of Oxford, and a world-renowned health research unit. The KWTRP works together with scientists, health services and local communities to achieve better health, while also developing local scientific leadership and infrastructure.

KEY RESPONSIBILITIES:

• Ensure effective project plans are in place and operational for each trial and work proactively with the trial team to set priorities in accordance with applicable project plans, standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements; and maintain a register of risks and implement strategies to mitigate risk in collaboration with the QA manager.
• Establish systems to track trial progress, milestones and performance metrics.
• Provide efficient updates on trial progress to the PI, with respect to project plans, trial budget and timeline management, recruitment, inventory management, and trial conduct.
• Oversee organizational structures, work schedules, task management and project milestones; be responsible for analysis, monitoring and evaluations of targets and strategic objectives; identify potential delays, bottlenecks and their effects on project deliverables; and implement strategies to ensure operational effectiveness.
• Lead study planning and start-up process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF) and study planning meetings.
• Supervise clinical trial coordinators to develop, track and report work schedules, task management and milestones and to ensure the alignment of these activities with the overall project priorities.
• Contribute to strategic planning and oversight of capital, operating budgets and expenditures for research grants and future grant applications in liaison with the finance and grants departments at KWTRP and the University of Oxford.
• Responsibility for ethics and regulatory document preparation and submissions, timely report submissions and communication with ethics and regulatory bodies.
• Develop or supervise development of Standard Operating Procedures (SOPs) for the projects together with the study team and conduct training/supervise training on SOPs/SIVs and ensure that clinical teams fulfil their roles and responsibilities.
• Determine communications needs, and plan and assess communications strategies and media interaction in accordance with KWTRP policies.
• Responsibility for the day-to-day running of the projects through the administrative team at KWTRP in Kilifi, and other trial sites where necessary; and liaise with KWTRP operations team for space planning and allocation of space for staff and visitors.
• Oversight and planning of key trial meetings and arrangements for visitors in liaison with KWTRP operations and key administrative staff.
• Responsibility for maintenance of study records and documents, their secure storage, and ensuring all data are filled out appropriately and documents are up to date.
• Coordinate monitoring and audit visits and ensure that all requirements are met including availability of documentation and relevant staff.
• Liaise with the KWTRP Community Liaison Group to develop and implement site and community engagement strategies.
• Represent the research project to relevant internal committees, external organizations collaborators and project partners and, where appropriate, funding agencies.
• Create high quality project reports for funding agencies and project partners.
• Effectively provide support to the PI in the conduct of the trials.
• Participate in scientific and business meetings liaising with collaborators and project partners when required.
• Undertake other duties as assigned.

QUALIFICATIONS:

• A Masters in life sciences or equivalent from an accredited institution.
• A relevant first degree in biomedical sciences or other equivalent qualification.
• At least 5 years’ experience in clinical trials, including 3 years’ experience that is directly related to the duties and responsibilities specified above.

COMPETENCIES:

• Exceptional project management skills, proficiency in using project management tools and the ability to manage multiple large projects simultaneously.
• Significant skill in leadership, organization, prioritisation, problem solving and decision making.
• Financially literate with sound knowledge of budgeting methodologies and resource management concepts including proven experience of preparing and monitoring budgets and financial reports
• Demonstrable experience in writing high quality reports and presentations in English, with evidence of being attentive to detail.
• Ability to network, communicate, be diplomatic and maintain strong local and international relationships within a multi-cultural environment and wide diversity of people, and have experience in resolving disputes.
• Knowledge of regulatory requirements and best practices in clinical trials
• Strong leadership, organisational and planning ability, with an ethical standpoint
• Strong interpersonal and communication skills (oral and written)
• Training in GCP and research ethics

Desirable competencies

• Training in Project Management or equivalent from an accredited institution

PHYSICAL ENVIRONMENT/CONDITIONS:

• Based at the KEMRI-Wellcome Trust Research Programme in Kenya.
• Some travel to study sites and partners within and outside Kenya.
• Be available to work out of hours if necessary.