Clinical Research Coordinator Specialist

3 dni temu


Warszawa, Mazovia, Polska ICON Pełny etat

Clinical Research Coordinator is a key role in supporting Investigator Site staff in conducting clinical research studies according to project-specific requirements and regulatory guidelines.

The successful candidate will be responsible for assisting in study-related activities at the site level, ensuring compliance with protocols, Standard Operational Procedures (SOPs), and international and local clinical trial regulations (ICH GCP Guidelines, CFR, GDPR, HIPAA, etc.).

  • Serving as a primary point of contact for Investigator Site Staff and Sponsor representatives.
  • Supporting organization and execution of monitoring visits and audits at the Investigator Site, including arranging visits, preparing documentation, and coordinating with relevant site personnel.
  • Entering patient-specific data into applicable clinical systems (eCRF, ASM, etc.) and resolving data queries.
  • Arranging and coordinating patient visits and communication.
  • Collaborating with external service providers, such as central laboratories and couriers.
  • Maintaining assigned sections of the Investigator Site File and patient documentation.
  • Participating in internal meetings and teleconferences.
  • Assisting with additional study-related tasks as per the Investigator's requirements.
  • Reporting any issues encountered during site operations to the Line Manager.
  • Preparing reports on completed activities as per established timelines.
  • Performing a wide range of administrative tasks connected to the assigned studies, mainly working with eCRF (data entry, query resolution), ISF maintenance, being the first point of contact for the CRA, monitoring visit support, etc.
  • Performing other duties as assigned by the direct Line Manager.


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