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Clinical Research Associate 2 - FSP Team - Galicia Area

Job description

Our FSP department in Spain is looking for a CRA II to work for one of our sponsor and managing clinical studies in Oncology, Hematology and Immunology . Full remote role, you need to be based in Galicia, preferably in Santiago de Compostela and La Coruña.

Main Responsibilities:

  • Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.
  • Site and patient protection: ensures informed consent, protocol adherence, and regulatory compliance to safeguard study participants.
  • Data quality oversight: performs source document verification, CRF review, and manages data queries to ensure accuracy and completeness.
  • Operational site management: prepares trip reports, ensures audit readiness, manages study files, coordinates with vendors, and uses resources efficiently.
  • Safety reporting: tracks and follows up on Serious Adverse Events (SAEs), supporting report and narrative preparation.
  • Extended support activities: feasibility assessments, QC visits, EC submissions, budget support, training/mentoring of new staff, and local project coordination.
  • Cross‑functional communication & logistics: liaises with internal teams, manages study materials, and travels as required.

Qualifications required:

  • University Master's degree in healthcare or similar.
  • Basic understanding of the clinical trial process and foundational knowledge of applicable regulatory guidelines.
  • Fluency in both English and the local office language, in written and verbal communication.

Experience (Minimum Required):

mandatory 2 years experience in the role.

• Understanding of Regulatory Guidelines.

• Good computer skills with good working knowledge of a range of computer packages.

By stepping into this role, you’ll join a highly collaborative, supportive, and growth‑oriented environment where your development is valued and your contributions truly make an impact

Learn more about our EEO & Accommodations request here.

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