Act as the main point of contact and support for the assigned investigational sites.
Prepare, conduct, and report remote and onsite monitoring visits in accordance with the Monitoring Plan and applicable SOPs.
Assess investigational site performance and ensure compliance with study protocol, GCP, and regulatory requirements.
Perform all required activities during monitoring visits according to internal and/or sponsor procedures.
Document and track the management of issues and deviations identified during and between site visits.
Support investigational site staff in the resolution of issues/deviations and the development of Corrective and Preventive Action (CAPA) plans.
Collaborate with Biometry, Regulatory Affairs, and Safety departments to obtain necessary site documentation.
Key Interfaces
All departments within the Operations area.
Education
University degree in Medicine, Biology, Biochemistry, Pharmacy, Nursing, Psychology, Chemistry, or other life science fields.
Master’s degree in Clinical Study Monitoring or an equivalent qualification.
Training Requirements
Solid understanding of Good Clinical Practice (GCP).
Knowledge of the regulatory framework governing clinical studies.
Understanding of data protection regulations applicable to clinical research.
Experience
Minimum 1 year of experience in a similar role within clinical trials or internship experience in clinical research.
Candidates with strong interest in clinical trials will also be considered; training and mentorship will be provided.
Desirable experience in clinical investigations with medical devices.
Desirable experience using electronic platforms, including eCTMS and eTMF.
Languages
Spanish
Advanced English level (spoken and written).
Other Requirements
Ability and willingness to travel, both domestically and internationally.
Core Competencies & Skills
Knowledge of establi
📌 Clinical Research Associate (Barcelona)
🏢 Barcelona Clinical Coordinating Center (BCCC)
📍 Barcelona
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