To plan, develop, implement and coordinate operational and administrative aspects of outbreak pathogen vaccine trials.
The main purpose of the job will be the coordination of all activities required for the implementation of the Yellow Fever and the Rift Valley Fever vaccine trials. This will involve evaluating use of fractional doses of the Yellow Fever vaccine to asses efficacy and a novel ‘one-health’ Rift Valley Fever vaccine for several livestock species and humans. In particular, the post holder will work in consultation with the PI and clinical trial leads to ensure that all study logistics are performed on time, supervise the collection of data and participate in the communications and engagement strategy for the project.
- Principal Investigator
- Head of Clinical Trials Facility
BUDGET AND RESOURCE RESPONSIBILITY:
- As assigned by PI
JOB DIMENSIONS: The post will involve training and line managing trial staff. The job will involve the management of project activities on a day-to-day basis including the coordination of study visits, data and sample collection. The post holder will coordinate all the study activities including requisitions, tracking, ordering receiving and distributing supplies. In addition, he/she will oversee the collection of data and ensure that the staff adhere to the protocol and the regulatory requirements.
- Ensure that all the project activities are conducted in accordance with the protocol and provide on-going technical support necessary for the implementation of the study.
- 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. Responsible for ethics and regulatory document preparation and submission.
- Act as the liaison to facilitate communication between the project manager and the study team.
- Active participation in study set up through engaging in sensitization meetings with different stakeholders.
- Coordinate and conduct all staff training sessions on the protocol and SOPs.
- Coordinate monitoring and audit visits and ensure that all requirements are met including availability of documentation and relevant staff.
- Effectively provide support to the PI and/or Head of CTF in the conduct of the trials.
- Preparation of logistics for the study including the requisition of the necessary supplies.
- Participate in sample collection, and storage
- Ensure appropriate collection, storage and transport of samples.
- Monitoring data collection progress and making recommendations to the Principal Investigator.
- Supervision of the study staff including doing performance appraisals.
- In conjunction with the community Liaison Group (CLG), Identify stakeholders and determine strategic engagement strategies with the relevant stakeholders.
- Other duties that may be assigned from time to time.
- A degree in nursing or life sciences or a diploma in clinical medicine.
- At least 3 years research experience with basic knowledge of clinical research.
- Registered with a professional body.
SKILLS & COMPETENCE:
- Understanding and exposure to Good Clinical and Practice (GCP).
- Possess excellent writing skills that can be utilised to prepare reports or scientific materials when asked to do so.
- Possess excellent organisation skills for overseeing training of staff, safe record keeping and operational costs of the project.
- Able to work flexibly and productively with colleagues, researchers, external delivery partners and multiple stakeholders.
- Experience with leadership in a clinical trial or clinical research.
- Have a basic understanding of data analysis, that is useful in tracking study progress and for graphical presentation of the same.
- Excellent interpersonal and engagement skills.
- Based at the KEMRI/Wellcome Trust office in Kilifi.
- Occasional travel to clinic sites to troubleshoot, train and support the study team.
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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 25 March, 2019.
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).