Senior CRA II - Remote/Hybrid Dermatology Trials

Premier Research Group; España; Hybrid; EUR 42,000 - 56,000; Full time

Job summary

Premier Research Group seeks a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. You will support biotech, medtech, and specialty pharma companies in bringing life-changing medicines, devices, and diagnostics to patients.

The role can be offered as fully remote, hybrid, or office-based from Madrid, with country-wide monitoring and an average of 6 days on site per month.

Qualifications

• 2+ years in clinical trials and independent monitoring.
• Experience in Dermatology therapy area.
• Across all phases I–IV preferred; II and III considered.

Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
• Maintains submission of expenses according to travel and expense requirements within company guidelines.
• Monitors (remote, onsite, or other approved mode) focusing on data integrity and patient safety per country regulations.
• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site.
• Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites as required by clinical monitoring plan.
• Maintains TMF/eTMF as defined by the organization's processes per filing guidelines and understands essential documents per ICH/GCP.
• Reviews site documents and verifies they are accurate, complete, current, and include required updates.

Skills

Clinical monitoring

Data integrity

Study coordination

Remote monitoring

Education

Clinical/health degree

Licensed health-care professional

Tools

eTMF systems

Clinical trial software

Job description

Premier Research Group seeks a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. You will support biotech, medtech, and specialty pharma companies in bringing life-changing medicines, devices, and diagnostics to patients.

The role can be offered as fully remote, hybrid, or office-based from Madrid, with country-wide monitoring and an average of 6 days on site per month.