Reference Number: CTC170815
Category: Clinical Healthcare and Research
JOB PURPOSE:To oversee and manage a clinical trial according to Good Clinical Practice (GCP) guidelines, regulatory requirements and institutional guidelines.
REPORTS TO:The PrincipaI Investigator
PROFESSIONAL DEVELOPMENT & MENTORSHIP:
Lead Clinical Trials Coordinator
SUPERVISES:Trial teams at the study sites
The KEMRI-Wellcome Trust Research Programme conducts high quality clinical trials focussing on diseases that present a high burden for developing countries. The Clinical Trials Facility (CTF) oversees the design, strategy, coordination and governance of high quality phase I, II, III and IV clinical trials across East Africa. The CTF is involved in both investigator-led and externally-led multicentre trials involving drugs, vaccines, nutritional and systems interventions. The CTF aims to maximise opportunities for learning and training in order to maintain a cadre of highly skilled and experienced African trials staff from all disciplines.
The FLACSAM trial will examine the efficacy of different first-line antibiotic combinations amongst very sick children who are severely malnourished and are admitted to hospital. It is a large clinical trial that will be conducted across several sites, where study teams will be based.
The post holder will have a high level of responsibility for ensuring trial integrity, adherence to regulatory requirements, managing staff and ensuring that the trial runs smoothly. The post holder will need to be self-sufficient and be able to work unsupervised, often with an unpredictable timescale. The post is mentally demanding, and involves a high level of communication among trial staff, with trial sites, study participants, regulatory bodies and the wider community.
• Help develop and review protocols, CRFs and informed consent documents.
• Prepare and submit regulatory documents and obtain all relevant approvals for study initiation, continuation and amendments, and communication with regulatory bodies.
• Develop SOPs for the trial together with the study team and conduct training on SOPs and ensure that clinical teams fulfil their roles and responsibilities.
• Work in collaboration with the study team and relevant departments to ensure trial preparedness and smooth execution of trial activities.
• Maintain the Trail Master File and participant’s files appropriately, and put in place internal systems for quality control.
• Line management of site trial staff, including conducting performance reviews.
• Liaise with the Community Liaison Group to develop and implement site and community engagement strategies.
• Coordinate monitoring and audits and ensure that all requirements are met including availability of documentation and relevant staff.
• Coordinate ordering and distribution of resources, ensuring inventories are complete and estimate long-term requirements for supplies including obtaining import permits for study drugs and export permits for samples.
• Work with the data manager to create interim reports and presentations.
• Participate within the CTF in scientific and business meetings and assisting in monitoring/planning other trials.
QUALIFICATIONS, SKILLS & COMPETANCIES:
• A degree in nursing or life sciences, diploma in clinical medicine, or a Registered Nurse.
• At least three years’ experience of involvement in clinical trials including trial organisation, hands-on work in clinical trials, trials monitoring or adverse event reviewing
• 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
• Computer literate with proficiency in project management tools and Microsoft applications
• Experience in coordinating clinical trials
• Experience in training or teaching
• Experience in budget and resource management
• Based at the Clinical Trials Facility in Kilifi.
• Regular travel, including travel outside of working hours, within and out of the country to visit trial sites for site initiation and training and trouble shooting.
• Be available to work flexibly, out of hours as necessary.
• Exposure to patients and materials considered infectious and/or biohazards.
How to apply
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