Clinical Research Associate – VL

Nairobi, Kenya
[Closing date: 25 January 
2019]

 

Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception, DNDi has developed eight new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

DNDi Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programmes. This DNDi regional office conducts R&D projects in the Eastern Africa region (esp. Kenya, Uganda, Sudan, Ethiopia, Tanzania), including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, mycetoma, and others. It also leads capacity strengthening initiatives through multi-country research platforms with the objective to ensure sustainable R&D capacities for DNDi projects. The team has grown to approx. 35 people today. As part of the global strategy, DNDi is further empowering its regional teams to ensure a coherent regional development across disease areas and activities, while reinforcing coherence among disease clusters.

 

Purpose of the position

The CRA will play an important role in the development of new drugs and treatments for visceral leishmaniasis (VL). S/he will be involved in the visceral leishmaniasis study with focus on the clinical phases in accordance to Good Clinical Practices (GCP) standards, with regards to specific duties as set out below. The CRA will directly report to the Clinical Trial Manager in charge of the study and will work closely with the project manager and the trial data manager.

 

Specific job responsibilities

  • Maintain sponsor’s trial master files, ensuring their completeness and consistency with the applicable regulatory requirements
  • Plan monitoring of clinical trial sites and provides supervisory support to ensure compliance to GCP, protocols, and applicable regulations
  • Coordinate the day to day activities of the clinical trial monitoring activities including time-tabling, initial review of site visit reports and other study related reports
  • Perform monitoring at clinical trial sites
  • Identify monitoring issues and clearly communicates this to sites. Effectively resolves the issues through active follow up. These include findings of audits.
  • Provide input for Clinical Trial Protocols and is involved in preparing initial submissions packages and preparation of study related materials
  • Provide liaison and support for trial data management centre particularly Trial Statistician, Data Managers, and Data Management Assistants
  • Liaise with DNDi Africa office Administrator/Finance Manager for trial related activities and payments
  • Be familiar with pharmaceutical regulatory requirements, documentation, and processes within the region
  • Keep appropriate documentation of the trials with regards to logistical data in accordance to GCP
  • Coordinate trainings, meetings, and other logistical issues related to clinical trial sites
  • Prepare periodic reports as required to track project progress and identify any issues
  • Participate in efforts geared towards improving the effectiveness and efficiency of operations in accordance with the policies and procedures as laid down in the organization’s Quality

 

Job requirements

Skills and attributes

  • Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Clear and systematic thinking that demonstrates good judgment and problem solving competencies
  • Very Good communication skills in multicultural, multi-lingual environments
  • Ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Very good analytical skills
  • Ability to contribute to the project delivery under minimum supervision
  • Ability to manage small projects if delegated by upper levels with supervision
  • Ability to supervise an Intern or Apprentice

R&D technical skills

  • Very good knowledge of Drug Discovery/Development
  • Very good knowledge of Clinical Research/Development
  • Very good knowledge of Regulatory (GCP, GLP, and GMP)
  • Very good knowledge of disease/academia knowledge

Experience

  • Minimum of 3 years’ experience with graduate degree, at least one year with post graduate degree
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience working in clinical research with excellent knowledge of GCP principles
  • Experience of working in public and private sector is highly desirable

Education

  • Bachelor’s degree in medical related field

Other requirements

  • Public health and field work orientation is a plus
  • Fluency in English
  • Proficiency in local languages desirable
  • Good knowledge of Microsoft Suite
  • Frequent field travels to trial sites; up to 60%

 

 

To apply

  • Deadline for application: Accepting applications until 25 January 2019
  • Only shortlisted candidates will be contacted