Clinical Research Associate

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.
Careers
Clinical Research Associate
Private Foundation Món Clínic Barcelona
Barcelona

Key Responsibilities   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 established quality standards and ability to follow internal instructions.
Proactive attitude with a willingness to contribute to continuous improvement.
Familiarity with cloud-based IT platforms and digital tools.
Strong communication, reporting, and interpersonal skills.
Comfortable working within multidisciplinary teams.
Excellent organizational skills, independence, and strong time-management abilities.
Effective active listening and negotiation capabilities.
Rigorous, detail-oriented, and problem-solving oriented.
Sound decision-making and ability to manage complex situations.

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