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Study coordinator and data manager

Study Coordinator

A study coordinator is part of the research team and provides support in the development of a research study to ensure that it is conducted in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and current legislation.

The objective of a coordinator is to support the development of all research studies, ensuring their proper execution, from data entry from the source document to the study database, to the coordination of visits, conducting surveys or questionnaires, managing images, medications/medical devices, assisting external agents (e.g., study monitors/study sponsors), maintaining the investigator's file and study documentation, etc.

Tasks to be performed

  • Coordination with sponsors, managers, monitors, and/or CROs to prepare all necessary documentation for the implementation of the clinical trial (CT) or research study.
  • Knowledge of the protocol of the research study in which they participate and receiving training on it, either from the sponsor/monitor or the principal investigator, using the protocol and/or necessary support materials.
  • Manage and coordinate tasks associated with clinical research studies under the supervision and as directed by the principal investigator, monitor, or CT manager.
  • Constant communication with the principal investigator and collaborators, involved services, biobank, as well as with the research nursing staff, CT laboratory technicians, pharmacy service, and radiology service (if applicable) to ensure proper coordination and execution of the study.
  • Keep all research study documentation up to date (principal investigator file), according to the needs of the study and as directed by the sponsor, monitor, or CT manager.
  • Preparing for visits with patients/subjects in the study.
  • Managing subsequent appointments for patients/subjects participating in the research study.
  • Conducting surveys or Study questionnaires.
  • Management of research sample collection.
  • Request and submission of radiological images (if applicable)
  • Communication of incidents related to APPs to the study monitor or sponsor.
  • Support in reporting potential protocol deviations and Serious Adverse Events (SAEs) to the study sponsor and/or monitor.
  • Review the data in the medical records of the patients/subjects participating in the study to verify their correct collection and transfer said data to the study Database/CRD (paper or electronic).
  • Keep the Databases/CRDs (paper or electronic) updated and resolve all queries associated with them.
  • Periodic contact with the CT monitors to complete queries, update the CT status, and set short-term goals.
  • Assist with the monitors during their visits (start, monitoring, and closure), both in person and by phone.
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Contact email

Data Manager

A Data Manager is part of the research team and provides support in the management and handling of clinical data associated with a research study, ensuring that the data collection is carried out in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, as well as current legislation.

This profile is responsible for entering data from the source document (usually a medical record) into the study database (REDCAP, ACCESS, electronic data collection form (ECD), etc.).

The objective of A data manager provides support in the management and handling of clinical data for all research studies, ensuring their proper management.

Tasks to be performed

  • Review the data in the clinical histories of the patients/subjects participating in the study to verify their correct collection and transfer said data to the study's database/CRD (paper or electronic).
  • Keep the databases/CRDs (paper or electronic) updated and resolve all associated queries.
  • Periodic follow-up meetings with the monitor, the research team, or the person in charge of managing the research study.

Members of the unit

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