Clinical Research Associate: Monitor Trials & Data Quality

OPIS; Barcelona; On-site; EUR 45,000 - 55,000; Full time

Benefits offered by this job

Additional benefits

Career growth opportunities

Job summary

OPIS is hiring a Clinical Research Associate to manage and monitor multi-country trials, ensuring adherence to ICH-GCP and regulatory standards. You will oversee site selection, initiation, monitoring, and close-out activities, while safeguarding data quality and patient safety.

The role reports to the Clinical Project Manager and involves collaboration with sponsors, sites, and project teams. Requires a scientific degree and 2+ years’ CRA experience, with strong English and MS Office skills.

Qualifications

• Degree in a scientific field.
• Minimum 2 years’ CRA or clinical trial monitoring experience.
• Strong knowledge of ICH-GCP, ISO14155, and trial processes.
• Good English and Microsoft Office skills.

Responsibilities

• Identify, assess, and initiate investigational sites.
• Conduct feasibility, pre-study, initiation, monitoring, and close-out visits.
• Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements.
• Perform source data verification and ensure data accuracy and completeness.
• Monitor patient recruitment and support sites in meeting targets.
• Ensure proper reporting of adverse events and protocol deviations.
• Manage investigational product handling, storage, and accountability.
• Maintain study documentation (TMF/eTMF, Investigator Files).
• Write monitoring reports and follow-up communications.
• Collaborate with project teams, sponsors, and site staff.
• Support audits/inspections and mentor junior CRAs.

Skills

CRA experience

ICH-GCP knowledge

English language

Organizational skills

Communication skills

Teamwork

Education

Degree in a scientific field

Tools

Microsoft Office

Job description

OPIS is hiring a Clinical Research Associate to manage and monitor multi-country trials, ensuring adherence to ICH-GCP and regulatory standards. You will oversee site selection, initiation, monitoring, and close-out activities, while safeguarding data quality and patient safety.

The role reports to the Clinical Project Manager and involves collaboration with sponsors, sites, and project teams. Requires a scientific degree and 2+ years’ CRA experience, with strong English and MS Office skills.