The Barcelona Institute for Global Health (ISGlobal) is a cutting-edge institute tackling global public health challenges through research, policy translation and education. ISGlobal has a broad portfolio of communicable and non-communicable diseases, including environmental and climatic determinants, and applies a multidisciplinary scientific approach from the molecular level 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 and non-communicable diseases. ISGlobal is accredited with the Severo Ochoa Distinction, a seal of excellence from the Spanish Ministry of Science.
Lugar
Barcelona
The project
The BOHEMIA project aims to contribute to the global impact of malaria on public health by developing a complementary vector control strategy. Based in Barcelona but available to travel internationally, the successful candidate will support the Chief Scientific Officer (CSO) and Study Compliance team in monitoring multiple study protocols and overall quality control of the study. project in accordance with GCP guidelines. The Quality Control Officer will be responsible for tracking submissions, maintaining a master file of trials, providing support to CRAs in tracking studies, importing and repackaging drugs to study, and other QC-related tasks. In summary, the successful candidate will help oversee study tracking, monitoring and compliance, as well as quality control.
Support the Scientific Director (CSO) and Study Compliance team in monitoring multiple study protocols and overall quality control of the project in accordance with GCP guidelines.
Study follow-up:
- Track ethical review committee submissions in all BOHEMIA protocols as well as queries and approvals
- Inform responsible persons within the BOHEMIA team of deadlines for submission of progress reports to ethical review committees for all BOHEMIA projects
- Work in collaboration with the clinical trials manager of the study to:
– Maintain version control of protocols and supporting documents
– Maintain an up-to-date protocol submission tracking system
– Track progress report submissions from inception to submission
Study Monitoring/Quality Control:
- Provide unblinded reporting of serious adverse events to the Outreach Coordinator for a
declaration to the DSMB
- Review database reports for BOHEMIA Safety and Efficacy Protocol and identify data
anomalies
- Report data anomalies in the required format to the Lead Clinical Research Associate (LCRA)
- Identify non-compliance trends and inform the LCRA
- Assist the LCRA in creating monitoring spreadsheets based on bi-monthly reports from the
database
- Assist the LCRA in maintaining the electronic master record of trials, including filing and archiving of clinical trial documents, and maintenance of study records.
Other:
- With the support of the CSO, coordinate and oversee the supply of study medications, from procurement to on-site delivery, including required documentation.
- With the support of the CSO, coordinate and oversee the repackaging of study drugs.
- Perform other clinical trial related duties as required throughout the duration of the study.
Terms
Education and experience:
- Licence.
- At least 1 (preferably 2) years of experience supporting clinical trial management
- Knowledge of quality assurance processes and procedures
- Knowledge of Good Clinical Practice (GCP) guidelines
Languages :
- Excellent command of written and spoken English. Written project communications and day-to-day work will be in English.
- Spanish, Portuguese and/or Swahili are an asset.
Skills/Competencies
- Assumes ownership and responsibility for tasks and demonstrates effective self-management
- Rigorous monitoring to ensure quality and productivity standards of own work are maintained consistently and accurately
- Excellent organizational and time management skills
- Must be detail oriented, have the ability to prioritize and manage multiple tasks simultaneously
- Ability to communicate and interact competently and professionally at all levels in a diverse environment.
- Ability to work effectively in a team and independently
- Demonstrated adaptability and ability to manage a rapidly changing environment.
- Proficiency in electronic communications and Microsoft Office.
- Experience working in international environments and an interest in public health in developing countries are assets
Others
- Availability to travel abroad as needed no more than 25%
- Current GCP certification (a course will be provided upon hire)
How to register
Applicants must complete the application form and include the following code reference position: QCO_BOHEMIA_Jul22, attach the CV and a cover letter. Each attached document must be named with the candidate’s first and last name.
Applications will be accepted until July 29.
Applications will be accepted until 5:00 p.m. CET on the closing date.
Only applications submitted via the application form will be considered.
Only selected candidates will be contacted.
Interviews will take place on a rolling basis until a candidate is selected.
