JOB PURPOSE:
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.
REPORTING LINES:
Programmes Manager
BUDGET RESPONSIBILITY:
Budget planning, oversight, monitoring and reporting responsibilities.
JOB DIMENSIONS:
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.
KEY RESPONSIBILITIES:
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.
QUALIFICATIONS:
- Masters’ degree in public health/epidemiology/clinical trials
- At least 8 years international experience in training on protocol, trial set up and research monitoring.
COMPETENCIES:
- 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.
DESIRABLE:
- Data analysis skills using analytical programmes e.g. Stata/ R
- Presentation skills
PHYSICAL ENVIRONMENT/CONDITIONS:
- 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.
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