Quality Control Officer for Broad One Health - Barcelona, España - CREAL

CREAL

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

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Descripción

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 uptodate 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 noncompliance
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.

Drug safety/Pharmacovigilance:

Maintaining an uptodate the study ́s Trial Master File File
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 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.
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

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 postholder.

Training and experience /Qualifications:

Bachelor's degree in relevant field (Masters preferred)
At least 2 years' experience in providing support to clinical trial management
Knowledge of quality assurance processes and procedures
Knowledge of good clinical practice (GCP) guidelines

Skills:

Takes ownership and responsibility for tasks and demonstrates effective selfmanagement
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

Language level: