Clinical Research Associate - VL at Drugs for Neglected Diseases initiative (DNDi)

Job description

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

• Please submit your application using the online form
• Deadline for application: Accepting applications until 25 January 2019
• Only shortlisted candidates will be contacted