Clinical Research Associate: Oncology Trials Specialist

OPIS s.r.l.; Barcelona; On-site; EUR 42,000 - 52,000; Full time

Benefits offered by this job

Additional benefits

Job summary

OPIS s.r.l. is seeking a Clinical Research Associate to monitor and manage multi-country clinical trials, ensuring compliance with study protocols, ICH-GCP, and regulatory requirements.

This role emphasizes site initiation, monitoring visits, data quality, and patient safety, reporting to the Clinical Project Manager. The successful candidate will have a scientific degree, at least two years of CRA or trial monitoring experience (oncology and phase 1 studies preferred), strong English, and

Qualifications

• Degree in a scientific field required.
• Minimum 2 years’ CRA or clinical trial monitoring experience (oncology and phase 1 studies desirable).
• Strong knowledge of ICH-GCP, ISO14155, and clinical 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

Strong organizational skills

Excellent communication

Problem-solving abilities

Teamwork

Education

Degree in a scientific field

Tools

Microsoft Office

Job description

OPIS s.r.l. is seeking a Clinical Research Associate to monitor and manage multi-country clinical trials, ensuring compliance with study protocols, ICH-GCP, and regulatory requirements.

This role emphasizes site initiation, monitoring visits, data quality, and patient safety, reporting to the Clinical Project Manager. The successful candidate will have a scientific degree, at least two years of CRA or trial monitoring experience (oncology and phase 1 studies preferred), strong English, and