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
What We Are Looking for
ISGlobal is seeking a Quality Control Officer who is interested in taking over and managing activities of the project BOHEMIA.

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.

Key Responsibilities
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 (CTM) 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
Review database reports for the BOHEMIA Safety and Efficacy protocol and identify data anomalies
-Report data anomalies in the required format to the Lead Clinical Research Associate (LCRA)
-Identify trends in non-compliance

Assist the LCRA in creating monitoring spreadsheets based on fortnightly reports from the database
Maintain the electronic Trial Master File on behalf the CTM, including filing and archiving of clinical trial documents, and the maintenance of study files.