Research Medical Specialist I at KEMRI Wellcome Trust Research Programme (KWTRP)

OVERALL JOB PURPOSE:

• To undertake research/ clinical trials and ensure compliance with statutory, regulatory and programme policies in performing/overseeing clinical activities and the execution of research studies.

REPORTS TO:

• Directly to Principal Investigator.

DIRECTLY SUPERVISES:

• Research medical officers

INDIRECTLY SUPERVISES:

• Clinical Officers/Fieldworkers.

BUDGET AND RESOURCE RESPONSIBILITY:

• Work planning and task allocation, requisition and procurement of supplies, consumables and ensuring sensible use of resources.

JOB DIMENSIONS:

The KEMRI-Wellcome Trust Collaborative 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 Clinical Trial Facility (CTF) is involved in both investigator-led and externally-led single and multicentre trials involving vaccines, drugs, nutritional, health systems, and behavioural interventions. The facility is responsible for overseeing the design, strategy, coordination and governance of high-quality phase I- IV clinical trials across Africa and Human Infections Studies. The CTF aims to maximise opportunities for learning and training with the aim of maintaining a cadre of highly skilled and experienced staff from all disciplines.

The research medical specialist will be responsible for overseeing day-to-day clinical activities related to the Shigella4V vaccine trial. Together with the Principal Investigator, the post holder will safeguard the health and welfare of the participants and ensure staff compliance with the protocol. Additionally, the post holder will perform and oversee clinical procedures and make trial-related medical decisions. He/she will work with the Principal Investigator to contribute to tasks preparatory to the project not limited to proposal/protocol development and submissions, develop a study work plan, organise and conduct training for project specific staff including higher level responsibilities for ensuring field and laboratory procedures are carried out as well as data analysis, preparation of reports and manuscripts and correspondence with international collaborators and sponsors. The post holder will need to be self-sufficient and be able to work with minimal supervision in a demanding environment, often with unpredictable timelines. The post is mentally demanding and extremely good communication is essential. The post holder may also be required to contribute to other associated projects.

KEY RESPONSIBILITIES:

• Work with the Principal Investigator and the project manager to prepare and execute research plans in liaison with the clinicians and other teams in the laboratory and the community liaison group.
• Take the lead in/contribute to the study set up, identification of resource requirements, documentation of protocols, staff training and grading and identifying adverse events.
• Work with the clinical team and researchers to provide good quality clinical care to the study participants throughout the study period.
• Ensure that the rights, safety and welfare of the study participants are protected, and clinical trial activities are conducted in accordance with the protocol, GCP and the regulatory guidelines.
• Ensure adherence to the clinical SOPs regarding clinical and laboratory investigations of the participants in the study.
• Carry out desktop research/ literature reviews and prepare/ draft write-ups as may be required for inclusion in/ to support proposals, presentations/seminars and publications.
• 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 the study protocol.
• Prepare, analyse and present research summaries to supervisors, community and county stakeholders, international collaborators, and sponsors.
• Liaise with the data clerks and managers to ensure that all data is entered into relevant databases on time and verified.
• Prepare and submit draft reports as required including activity reports, project progress reports amongst others.
• Attend and actively participate in investigator’s meetings and other meetings within the department and programme e.g. journal clubs/seminars as needed.
• And any other duties that may be assigned by supervisors from time to time.

QUALIFICATIONS:

Essential

• A degree in Medicine and Surgery.
• MSc or MPH
• Demonstrable active interest and/or experience in biomedical research.
• Minimum 5 years’ post qualification experience.
• Eligibility for registration with the Kenya Medical Practitioners and Dentists Board i.e. you should have completed your internship by the time you commence the position.
• Ability to lead and work within a team.
• Excellent presentation and communication skills.
• Training and or experience in clinical research
• Training/ experience in literature research, critical appraisal of literature and evidence reviews.
• Computer literacy with proficiency in Microsoft applications.

Desirable:

• Training in ICH-GCP.
• Experience in both adult medicine and paediatrics (clinical or research)
• 2-3 years’ experience in clinical trials
• Experience/qualification in basic bio-statistics and clinical research. Current passport and ability to travel for international meetings.

COMPETENCIES:

• Knowledge of basic study designs and how to conduct clinical research studies.
• Good analytical and follow through ability.
• Good planning, organisation and co-ordination skills and attention to detail.
• Ability to take and follow instructions, initiative, keen to learn and proactive with the ability to work under minimal supervision.
• Flexibility, adaptability, ability to multi-task.
• Confidentiality and integrity.
• Excellent interpersonal and communication skills.
• Team working and ability to work in a multi-cultural environment. Conscientiousness, timeliness and willingness to work to meet deadlines.

PHYSICAL ENVIRONMENT/CONDITIONS:

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