To plan, implement and coordinate International Multisite clinical research operations in the childhood infectious diseases and undernutrition at KWTP Kilifi/Coast and across international networks. The post holder will need to be experienced in leading multi-disciplinary, multi-site research teams in an international setting and be highly self-sufficient to manage complex research work. The post is mentally demanding, involving attention to detail and timescales, and strong engagement with stakeholders.
Budget planning, oversight, monitoring and reporting responsibilities.
The post holder will be based in from Kilifi site to promote effective management of ongoing research studies by closely working with clinical leads/project coordinators and study teams in the international network at Coordination level.
Administrative oversight – Kilifi/Coast:
- Overall coordinator of Kilifi/Coast study teams focussing on childhood undernutrition and related projects, to oversee administrative aspects of staffing, project budgeting, procurement, security, health and safety
- Provide site leadership (Kilifi/Coast) to malnutrition study teams and to be point of contact between other KWTRP departments and the teams on administrative issues.
- Provide guidance to project coordinators and investigators of ongoing/planned studies within the malnutrition team to include study planning, resources allocation and quality assurance plans.
- To undertake/guide risk assessment of studies together with specific study coordinators / investigators, to maintain a register of the risks, and to participate in developing risk mitigation measures drawing from administrative support in KWTRP in accordance to applicable policies and guidelines
- To lead/guide resolution of operational challenges/problems affecting study teams
- Participate in writing of project ghant charts, implementation timelines, and identification of milestones and to use this to regularly monitor overall project progress.
Scientific coordination – Kilifi /Coast:
- Manage process of ethics and scientific applications and renewals for ongoing protocols/studies, and trial registration.
- Coordinate team’s planning and management of all clinical trials to include design of research systems in line with applicable institutional, regulatory and international standards.
- Manage development of training plans for new research protocols, as well as overall staff development trainings and mentorship.
- Manage and guide on preparation of SOPs, data collection tools (CRFs/Source documents), quality manuals and processes in line with institutional guidelines and international research standards (GCP)
- Represent teams in operations and scientific committees and stakeholder forums at local and international level, to include Centre Scientific Meetings, Research steering committees (DSMBs/TSCs), sponsors and external partners.
- Coordinate stakeholder’s engagement for new and ongoing studies and to maintain register of completed meetings and planned updates.
- Manage scientific peer interaction and exchange within the study teams and with wider KWTRP/stakeholders in form of scheduled workshops, journal clubs, seminars or case presentations.
International CHAIN network coordination roles:
- Work at CHAIN network to coordinate training in international sites on protocol implementation processes to include data collection processes and quality assurance measures.
- Lead clinical trials platform in the CHAIN network to establish systems and resources to implement and /or support new clinical trials.
- Participate in remote monitoring of progress at international CHAIN sites through conference meetings and report updates.
- Participate in monitoring visits to international CHAIN network sites to review progress and conduct required trainings.
- Participate in review of data quality and completeness in network sites, and communication with clinical and laboratory teams over query resolutions
- Undertake own research projects/ data analysis within ongoing/completed studies that contribute to the overall research understanding of questions under research by Malnutrition study group.
- Masters’ degree in public health/epidemiology/clinical trials
- At least 8 years international experience in training on protocol, trial set up and research monitoring.
- Exceptional project management skills, proficiency in using project management tools and the ability to manage multiple large projects simultaneously.
- Significant skills in leadership, organization, prioritisation, problem solving and decision making
- Demonstrable experience in writing high quality reports and presentations in English, with evidence of being attentive to detail.
- Ability to network, communicate, diplomatic and maintain strong local and international relationships within a multi-cultural environment and wide diversity of people, and have experience in resolving disputes.
- Data analysis skills using analytical programmes e.g. Stata/ R
- Presentation skills
- Based at the KEMRI/Wellcome Trust Research Programme in Kenya.
- Regular international travel to study sites and partners.
- Be available to work out of hours if necessary.