Clinical Research Associate 2

This is a fully remote position, open to applicants in Spain.

📋 Description

• Conduct site monitoring visits, which include selection, initiation, monitoring, and close-out activities.

• Lead and oversee subject recruitment strategies in collaboration with study sites.

• Provide training on protocols and study procedures to designated sites.

• Maintain consistent communication with sites to manage project expectations and address any issues.

• Assess site practices for compliance with protocol quality, integrity, and regulatory standards.

• Report quality issues when necessary.

• Monitor regulatory submissions, approvals, recruitment, enrollment, CRF completion, and data inquiries.

• Assist during the study start-up phase as needed.

• Ensure that site documents are prepared for filing in the Trial Master File.

• Confirm that the Investigator's Site File is maintained according to GCP and local regulations.

• Keep up-to-date site management and monitoring documentation, including visit reports, follow-up letters, and study records.

• Work collaboratively with study team members to facilitate project execution.

• Aid in the development of site-specific subject recruitment strategies when necessary.

• Assist with site financial management and invoice collection when applicable.

⛳️ Requirements

• Bachelor's Degree in a scientific field or healthcare is preferred.

• A minimum of 1.5 years of experience in on-site monitoring is required.

• A combination of education, training, and experience may be considered equivalent.

• Strong organizational, time management, and problem-solving abilities.

• Capability to establish and maintain effective working relationships with colleagues, managers, and clients.

• Willingness to travel as necessary.

• Valid driver’s license.

• Familiarity with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Competence in conducting site monitoring visits and managing clinical study documentation.

• All application information and credentials must be accurate and complete.

🏝️ Benefits

• A collaborative work culture.

• Opportunity for remote work within Spain.

• Chance to work across various therapeutic areas.

• A strong commitment to diversity, inclusion, and belonging.