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Quality Control Officer for Broad One Health
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**Descripción**: 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.
**Lugar**:
- 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
- Support review of electronic data to identify potential risks and trend critical data and processes
- Maintain the electronic Trial Master File on behalf the CTM, including filing and archiving of clinical trial documents, and the maintenance of study files.
**Drug safety/Pharmacovigilance**
- Conduct quality control of severe adverse (SAE) event and pregnancy follow up reports from site
- Provide unblinded SAE reports to the Outreach Coordinator for monthly reporting to ethics committees
- Submission and/or support of submissions of blinded CIOMS-I forms to ethics committees
**Other**:
- Support CSO with the QC of the ethics submissions and reports.
- With support from the CSO, coordinate and oversee study drug supply from procurement to delivery on site, including the required documentation.
- Take on other clinical trial related tasks on an as needed basis throughout the duration of the study
**Auxiliar task**:
- This job description reflects the present requirements of the post but may evolve at any time in the future as duties and responsibilities change and/or develop providing there is appropriate consultation with the post-holder.
**Requirements**:
**Training and experience /Qualifications**:
- Bachelor’s degree in relevant field (Masters preferred)
- At least 2 years’ clinical operations experience providing support to clinical trial management/operations teams, preferably in a global environment, (e.g., Lead CRA, Clinical Trial Assistant, Clinical Trial Manager)
- Knowledge of quality assurance processes and procedures
- Knowledge of good clinical practice (GCP) guidelines
**Skills**:
- Takes ownership and responsibility for tasks and demonstrates effective self-management and proactivity
- Strong follow through to ensure that quality and productivity standards of own work and that of the team are consistently and accurately maintained
- Critical thinker capable of supporting the project with creative solutions when needed in a fast paced environment
- Ability to leverage clinical research experience to adapt to a non-traditional research environment to ensure standards of ICH GCP are 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 at times with ambiguity
- Proficiency with electronic communications and Microsoft office.
- Experience in working in international environments and interest in public health in developing countries are assets
**Language level**:
- 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
**Specific Requirements**:
- Availability t
