The Barcelona Institute for Global Health (ISGlobal) is a cutting-edge institute addressing global public health challenges through research, translation into policy and education. ISGlobal has a broad portfolio in communicable and non-communicable diseases including environmental and climate determinants, and applies a multidisciplinary scientific approach ranging from the molecular to the population level. Research is organized in the following main areas, Malaria and other Infectious Diseases, Maternal, Child and reproductive Health, Urban Health and Child and environmental health, Climate & Non-Communicable Diseases. ISGlobal is accredited with the Severo Ochoa distinction, a seal of excellence of the Spanish Science Ministry.

Venue:
Barcelona

The project:
The BOHEMIA project aims at contributing to the global public health impact for malaria developing a complementary vector control strategy. Based in Barcelona but with availability to travel overseas, the successful candidate will support the Chief Scientific Officer (CSO) and study compliance team in the tracking of the study´s multiple protocols and the overall quality control of the project according to GCP guidelines. The Quality Control Officer will be responsible for tracking submissions, maintaining an up-to-date Trial Master File, providing supports to the CRAs in study monitoring, study drug importation and repackaging, and other QC related duties. In summary, the successful candidate will help oversee study tracking, monitoring and compliance, and quality control.
Support the Chief Scientific Officer (CSO) and study compliance team in the tracking of the study´s multiple protocols and the overall quality control of the project according to GCP guidelines.

Study Tracking:
Track submissions to ethics review committees across all BOHEMIA protocols as well as queries and approvals
Notify responsible persons within the BOHEMIA team of deadlines for submission of progress reports to ethics review committees across all BOHEMIA projects
Work in conjunction with the study´s Clinical Trial Manager to:

• Maintain version control of protocols and supplementary documents
• Maintain an up-to-date protocol submission tracking system
• Track progress report submissions from start until submission

Study Monitoring/ Quality Control:

• Provide unblinded Serious Adverse Event reports to the Outreach Coordinator for monthly
  reporting to the DSMB

• Review database reports for the BOHEMIA Safety and Efficacy protocol and identifies data
  anomalies

• Report data anomalies in the required format to the Lead Clinical Research Associate (LCRA)

• Identify trends in non-compliance and inform the LCRA

• Assist the LCRA in creating monitoring spreadsheets based on fortnightly reports from the
  database

Assist the LCRA in maintaining the electronic Trial Master File, including filing and archiving of clinical trial documents, and the maintenance of study files.

Other:
With support from the CSO, coordinate and oversee study drug supply from procurement to delivery on site, including the required documentation.
With support from the CSO, coordinate and oversee study drug repackaging.
Take on other clinical trial related tasks on an as needed basis throughout the duration of the study.

Requirements:

• Education and Experience:
• Bachelor’s degree.
• At least 1 (preferably 2) years’ experience in providing support to clinical trial management
• Knowledge of quality assurance processes and procedures
• Knowledge of good clinical practice (GCP) guidelines

Languages:

• Excellent fluency in written and spoken English. Project written communications and daily work will be in English.
• Spanish, Portuguese and/or Swahili are an asset.

Skills/competences:
Takes ownership and responsibility for tasks and demonstrates effective self-management

• Strong follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
• Excellent organizational and time management skills
• Must be detail oriented, have the ability to prioritize and handle multiple tasks simultaneously
• Ability to communicate and interact competently and professionally at all levels within a diverse environment.
• Ability to work effectively both as a team member and independently
• Demonstrated adaptability and ability to manage a rapidly changing environment.
• Proficiency with electronic communications and Microsoft office.
• Experience in working in international environments and interest in public health in developing countries are assets

Others:
-Availability to travel overseas as required no more than 25%
-Current GCP certification (a course will be provided upon hiring)