Research Medical Officer II
Reference Number:
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 activities and execution of research studies.
The post holder will be responsible for day-to-day clinical activities, aiding day-to-day organisation and coordination of the research studies and trials, leading safety monitoring on clinical trials, contribute to protocol and SOP development, and day-to-day supervision of clinical staff. Although these are the primary responsibilities, the post-holder will work within a team and will be expected to share the load and as guided by the line manager.
This post is open qualified doctors with some research experience and will be funded until for a five-year period. The job will include on the job training in research methods and programme management as well as roles in data management, sample/specimen management, analysis, and preparation of publications.
REPORTS TO:
- Principal Investigator
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 programme aims to maximise opportunities for learning and training in order 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 diseases, 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-holders will be responsible for performing duties as a medical officer on the clinical trials and overseeing day-to-day clinical activities related to the trials. The post holder will work with the Principal Investigator and clinical leads on the project(s) to: ensure safety and clinical care of all study participants; contribute to tasks preparatory to the project, 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 an procedures. The post holder will also be involved in higher level responsibilities for ensuring all clinical activities and procedures are carried out to quality standards as well as data analysis, preparation of reports and manuscripts.
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.
KEY RESPONSIBILITIES:
- Work with the Principal Investigator, clinical investigator leads and other relevant staff members to 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 participants.
- Supervise and mentor other study team members, i.e. Clinical Officers, Nurses, etc.
- 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 study protocols.
- Prepare, analyse and present research summaries to supervisors, Kilifi County public health staff, international collaborators and sponsors.
- 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 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 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:
- Bachelor of Medicine and Bachelor of Surgery (M.B;Ch.B.) degree
- 1-3 years’ post qualification work experience.
- Demonstrable active interest and/or experience in biomedical research.
- 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.
- Competency in basic procedures of clinical investigation.
- Ability to lead and work within a team.
- Excellent presentation and communication skills.
- Training and/or experience in epidemiology/public health or any relevant field.
- 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/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:
- 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.
- Be available to work out of hours if necessary.
- Some travel to study sites and partners within and outside Kenya.
- Exposure to materials considered infectious and/or biohazards.
APPLICATION PROCEDURE:
To apply for this post you must be a registered user. Log into your account then go to Vacancies, view the post and click on the button: "Apply for this job".
All applicants are required to state their current/last salary.
Candidates must supply an email and telephone contact that will be used when offering interviews. Only shortlisted candidates will be contacted. Shortlisted candidates shall be required to produce ORIGINALS of their National Identity Card, academic and professional certificates, original transcripts and testimonials, detailed curriculum vitae and valid clearance certificate (certificate of good conduct) during the interviews.
The application closing date is 2 August 2021.
KEMRI-Wellcome Trust Research Programme (KWTRP) is an equal opportunity employer. Direct or indirect canvassing will lead to automatic disqualification. KWTRP does not charge a fee at any stage of the recruitment process (application, interview, meeting, processing, training or any other fees).
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