KEMRI Wellcome Trust Research Programme (KWTRP)  recruitment : Open Jobs ( June 2024)/ Online application

JOB PURPOSE: 

This role is responsible for planning, developing, implementing and coordinating technical, operational and administrative aspects of the RVF003 clinical trial of a Rift Valley Fever vaccine and ensure compliance with the protocol, ethics and regulatory guidelines and in accordance with ICH GCP. To work closely with the PI, other internal and external stakeholders to ensure the trial is delivered within time, budget and scope. The post holder will need to be self-sufficient and be able to work with minimal supervision in a demanding environment, often with unpredictable timelines. The post is mentally demanding and extremely good communication is essential. The post holder may also be required to contribute to other associated projects.

Description: 

REPORTS TO:  Principal Investigator

DIRECTLY SUPERVISES: Study Coordinator

INDIRECTLY SUPERVISES: None.

BUDGET AND RESOURCE RESPONSIBILITY:  

• Managing study imprest and work closely with the PI in developing budgets.
• Approval of requests on the financial management system (FMS).

JOB DIMENSIONS:

KEY RESPONSIBILITIES:

• Ensure effective project plans are in place and operational for the trial and work proactively with the trial team to set priorities accordingly.
• Maintain register of risks and implement strategies to mitigate risk in collaboration with relevant teams.
• Oversee organizational structures, work schedules, task management and project milestones and implement strategies to ensure operational effectiveness.
• Lead study planning and start-up process.
• Develop Standard Operating Procedures (SOPs) for the project together with the study team and conduct training/supervise training on SOPs/SIVs.
• Lead community engagement activities, liaise with the community liaison group (CLG) to develop strategies for trial recruitment.
• Establish and update systems to track trial progress, milestones and performance metrics.
• Coordinate monitoring and audit visits and ensure that all requirements are met.
• Maintain study records and documents, their secure storage, and ensure all data are filled out appropriately and documents are up to date.
• Create job descriptions and staff requisition forms for job advertisements for projects, conduct interviews and selection.
• Contribute to strategic planning and oversight of capital, operating budgets and expenditures for research grants and future grant applications in liaison with all relevant stakeholders.
• Prepare and review routine reports to funders, relevant stakeholders.
• Prepare ethics and regulatory documents and submissions, ensure timely report submissions and communicate with ethics and regulatory bodies.
• Supervise clinical trial coordinators to develop, track and report work schedules, task management and milestones and ensure alignment of activities with project priorities.
• Manage leave for project staff and ensure leave taken is as per the Programme policy
• Determine communication needs, plan and assess communication strategies and media interaction for the project and liaise with Communications teams.
• Organise key trial meetings, including DSMB to discuss trial progress.

QUALIFICATIONS:

• Bachelor of Science degree in relevant biological research field. Master’s an added advantage.
• Minimum 5 Years’ management experience with 3 Years’ experience in managing and coordinating research projects; management of clinical trials an added advantage

DESIRABLE CRITERIA:

• Project Management Certification
• Good knowledge of project management framework best practices as defined under PRINCE2 or PMP and ability to implement a project successfully.
• Financially literate with sound knowledge of budgeting methodologies and resource management concepts including preparing and monitoring budgets and financial reports.
• Ability to communicate effectively to a high standard, including relatively complex scientific matters, orally and in writing
• Knowledge of ethical and regulatory requirements and best practices in clinical trials.

COMPETENCIES:

• Unquestionable integrity
• Excellent interpersonal, written, presentation and communication skills
• Good analytical, problem solving and critical thinking skills
• Ability to work as part of a team in a multi-cultural environment
• Strong flexibility, adaptability and attention to detail
• Strong team coordination and supervisory skills.

JOB PURPOSE: 

The post holder will be responsible for overseeing day-to-day clinical activities related to the RVF003 vaccine trial, evaluating the immunogenicity and safety of a Rift Valley Fever vaccine. Together with the Principal Investigator, the post holder will safeguard the health and welfare of the participants and ensure staff compliance with the protocol. Additionally, the post holder will perform and oversee clinical procedures and make trial-related medical decisions. He/she will work with the Principal Investigator to contribute to tasks preparatory to the project including protocol development and submissions, developing a study work plan, organising and conducting training for project-specific staff, and higher level responsibilities for ensuring field and laboratory procedures are carried out as well as data analysis, preparation of reports and manuscripts and correspondence with international collaborators and the sponsor. The post holder will need to be self-sufficient and be able to work with minimal supervision in a demanding environment, often with unpredictable timelines. The post is mentally demanding and extremely good communication is essential. The post holder may also be required to contribute to other associated projects.

Description: 

REPORTS TO:  Principal Investigator

DIRECTLY SUPERVISES: Clinical officers, fieldworkers, nurses

BUDGET AND RESOURCE RESPONSIBILITY:   Management of study imprest

JOB DIMENSIONS:

KEY RESPONSIBILITIES:

• Provide medical oversight of trial participants including ensuring good clinical governance at the study site(s) with regards the clinical evaluation of participants
• Coordinate the activities of clinical study team members, ensuring Good Clinical Practice (GCP) in all aspects of study implementation
• Appraise performance of study clinicians, nurses, and fieldworkers
• Supervise the clinical research team as required in the provision of patient care, and data management while ensuring adherence to study protocols and procedures
• Maintain high quality research output through undertaking research analysis and scientific writing for publication
• Evaluate skill-mix and skill requirements within the site-based clinical teams and build capacity of team through on-the-job training as required
• Ensure study staff are adequately trained on most currently approved study documentation including trial protocol, standard operating procedures.
• Contribute to drafting reports to the relevant ethics, regulatory and safety bodies.
• Drafting clinical reports and peer-reviewed journal articles for stakeholders on both national and international levels, as well as for research funders.

QUALIFICATIONS:

• Undergraduate degree in Medicine and Surgery. added advantage Master’s degree in public health, infectious diseases, epidemiology or other allied discipline
• At least 3 years’ post-qualification experience in adult clinical medicine
• Registered with the Kenya Medical Practitioners and Dentists Board
• Ability to cover clinical visits on an on-call rota basis

DESIRABLE CRITERIA:

• Understanding of Good Clinical Practice
• Experience of working in clinical studies
• Training in adult life support (basic and/or advanced)
• Management experience
• Computer literacy with proficiency in Microsoft applications

COMPETENCIES:

• Unquestionable integrity
• Excellent interpersonal, written, presentation and communication skills
• Good analytical, problem solving and critical thinking skills
• Ability to work as part of a team in a multi-cultural environment
• Delegation and teamwork