Clinical Trials Coordinator – VIRUTUBISHO Trial – Kenya

OBJECTIVE OF THE POSITION:

Plan, implement and coordinate clinical research operations in the Maternal and Child Nutrition Research Group of KWTRP Kilifi/Coast. The post holder will be responsible for managing a community-based clinical trial of multiple micronutrient supplementation for women of reproductive age (non-pregnant and pregnant) in Kilifi County (VIRUTUBISHO trial). The incumbent must have experience in leading research teams and be highly autonomous in managing complex clinical trial research work. The role is mentally demanding, involves attention to detail and deadlines, and strong engagement with stakeholders.

REPORTING LINES:

• Principal investigator of the VIRUTUBISHO trial.

BUDGET RESPONSIBILITY:

• Budget planning, oversight, monitoring and reporting responsibilities

WORK DIMENSIONS:

The KEMRI-Wellcome Trust Research Program (KWTRP) is a world-renowned research institution in Kenya that conducts studies of public health interest. An area of ​​great public health interest is maternal and child nutrition research that aims to improve the health of vulnerable women of reproductive age (WRA) in developing countries. The group focuses on the care of mothers at nutritional risk and infants under 6 months (MAMI). We assessed the contribution of maternal nutrition and maternal risk factors to poor infant outcomes. We applied a mixed method approach to assess breastfeeding problems in the 1st month of life, hospital-based studies of infants with severe wasting in the first 6 months of life to improve support breastfeeding inside and outside the hospital (IBAMI1 & 2). We are members of NeoNunet; a collaborative network of Nigerian and Kenyan neonatal units set up to assess evidence of feeding preterm and low birth weight infants.

The VIRUTUBISHO trial aims to optimize nutrient requirements for maternal supplementation. This is a Phase 2b dose-finding pharmacokinetic trial of Balanced Energy Proteins (BEPs) and Multiple Micronutrient Supplements (MMSs). This is a community-based trial that will recruit women of childbearing age from two locations in Kilifi North Sub-County.

The post holder will be based in Kilifi to promote effective trial management and participate in other group activities. They will work with an experienced team of clinical trial coordinators in the broader nutrition research group i.e. CHAIN ​​Network (https://chainnetwork.org/).

MAIN RESPONSIBILITIES:

Administrative monitoring

• General coordinator of the VIRUTUBISHO trial to oversee the administrative aspects of staffing, project budgeting, procurement and liability, security, health and safety
• Manage/supervise a team of clinical and field staff working in the VIRUTUBISHO trial
• Undertake/guide the study risk assessment with the study investigator, maintain a risk register and participate in the development of risk mitigation measures relying on administrative support from KWTRP as per applicable policies and guidelines
• Lead/guide the resolution of operational challenges/issues affecting the study team
• Participate in the drafting of project Gantt charts, implementation timelines and identification of milestones and use them to regularly monitor the overall progress of the project.

Coordination of studies

Manage the daily implementation of the VIRUTUBISHO trial.

• Coordinate the process of ethical and scientific inquiries and renewals of study protocol and trial registration.
• Manage the development of training plans for the research protocol, as well as general staff recruitment, development trainings and mentoring.
• Collaborate with scientific leads on the preparation of SOPs, data collection tools (CRF/source documents), quality manuals and processes in accordance with institutional guidelines and international research standards (GCP)
• Responsible for delivering interventions using Direct Observed Treatment (DOT) to provide Multiple Micronutrient Supplements (MMS) to trial women of reproductive age in Kilifi.
• Responsible for participant sampling, quality, completeness and transportation of samples from field sites to KWTRP laboratories for processing and storage
• Responsible for collecting data, reviewing on-site data quality and completeness, and communicating with clinical and field teams on query resolutions
• Participate in operational and scientific committees and stakeholder forums locally and internationally, such as monthly clinical trial center meetings.
• Coordinate stakeholder engagement in the VIRUTUBISHO study and maintain a record of completed meetings and planned updates.
• Facilitate follow-up of clinical and field documentation, review progress and implement follow-up recommendations which may include additional trainings.

QUALIFICATIONS:

Essential:

• Degree in public health/epidemiology/clinical trials or related fields
• At least 3 years of experience coordinating a clinical trial, including setting up a trial and working with trial monitors.
• Computer proficiency in the use of Excel, Ms word and power point sheets
• Exceptional project management skills, proficiency in project management tools and ability to manage an intensive clinical trial.
• Demonstrable experience in writing high quality reports and presentations in English, with evidence of attention to detail.
• Ability to network, communicate, resolve conflicts and maintain good working relationships in a multicultural environment.

Desirable:

• Community mobilization for a community trial
• Knowledge of the local context, culture and language is an added advantage

Skills :

• Demonstrate high levels of integrity and confidentiality
• Excellent interpersonal, writing, presentation and communication skills
• Good analytical, problem solving and critical thinking skills;
• Teamwork and ability to work with diverse teams
• Strong flexibility, adaptability, multitasking and attention to detail
• Strong team coordination and supervision skills.

PHYSICAL ENVIRONMENT/CONDITIONS:

• Based at the KEMRI/Wellcome Trust research program in Kilifi, Kenya.
• Be available to work after hours if necessary.