GARDP Clinical Research Associate

Geneva, Switzerland
[Closing date: 17 June 2018]   
                                                           

 

Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org)

The Global Antibiotic Research and Development Partnership (GARDP) is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavoring to ensure sustainable access. Initiated and incubated through close collaboration between WHO and DNDi, GARDP is part of the implementation of the Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships for encouraging research and development of new antimicrobial agents and diagnostics. GARDP is hosted by DNDi in its start-up phase.

GARDP’s mission is to work in partnership with the public and private sectors, to develop and deliver new treatments for bacterial infections where drug resistance is present or emerging, or for which inadequate treatment exists.

 

Purpose of the position

The CRA will be involved in the coordination, support, and documentation of projects throughout all stages of the development process, with particular focus on the clinical phases. As a CRA, s/he will report to Project Leaders/Managers in GARDP team and be responsible for monitoring and keeping track of GARDP resources for given projects.

Projects include the neonatal sepsis programme which aims to develop new, globally applicable, empiric antibiotic regimens and strategies for the treatment of neonatal sepsis in settings with varying prevalence of MDR pathogens and the sexually transmitted infections (STI) project, which aims to develop new treatments addressing the rise in MDR and XDR gonorrhea while being suitable for integration in STI syndromic management.

 

Specific job responsibilities

Develop project plans

  • Monitor project schedules and budgets with the Trial Manager/Project Leader and the partners
  • Monitor milestones for project evaluation with the Trial Manager/Project Leader
  • Play a full role in the R&D team
  • Be an active member of the DNDi/GARDP organization

Ensure regulatory compliance for projects

  • Be familiar with pharmaceutical regulatory requirements, documentation, and processes for major international agencies
  • Ensure projects follow GCP and regulatory compliance and keep appropriate documentation
  • Participate in preparing regulatory documentation
  • Participate in developing a quality management system and developing/reviewing SOPs

Manage and develop project reporting systems

  • Collect data and information to enable project managers and the R&D Director to make effective and cost-efficient use of DNDi/GARDP resources
  • Regular interaction with partners/CROs/study site teams to ensure that projects meet their milestones
  • Provide logistical support and tracking for all trial materials with partners, CRO, and other members of the project team

Enable review of projects

  • Provide progress reports to project managers on individual projects
  • Assist in the preparation of materials for presentation to the Scientific Advisory Committee (SAC) and other interim and formal reviews

Additional/specific/projects responsibilities

  • Develop and maintain the skills required for delivery of all aspects of clinical trials
  • Maintain an awareness of developments in the designated projects that relate to drug development
  • Be aware of developments in clinical development and the regulatory environment, and report these to DNDi/GARDP

 

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 middle sized projects with budget management under supervision
  • Provide specialist services to operational line or project team
  • Ability solve non-routine problems on a case by case/project basis
  • Have a certain autonomy for taking actions and decisions
  • Ability to interact with external stakeholders
  • Ability to be the focal point/manager for consultants
  • Ability to supervise at a smaller level

R&D technical skills

  • Knowledge of GCP and its application in clinical trial conduct

Experience

  • Minimum 6 years’ relevant experience in which at least 3 years at officer level or equivalent
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in clinical research is required

Education

  • MSc or PhD in life science

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Good knowledge of Microsoft Suite
  • Work Location: Geneva
  • Travel Required: Up to 25 %

 

Reporting line

  • He/she reports to the STI Project Lead
  • With functional reporting to the Clinical Trial Manager

 

Other information

  • Status: full time – permanent role

 

To apply

  • Deadline for application: Accepting applications until 17 June 2018
  • Only shortlisted candidates will be contacted.