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 GCPCoordinate 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
