Quality Control Officer for Broad One Health

hace 2 meses

Barcelona, España Somm Excellence Alliance A tiempo completo

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.

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.

**Deadline**: March 31, 2023
**Job category**: Administration
**Area**: Life Sciences

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