Senior Clinical Research Associate

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

📋 Description

• Execute site monitoring duties for clinical trials.

• Provide direction, leadership, and oversight in the management and execution of clinical trials to guarantee compliance and quality.

• Ensure timely and appropriate visits to investigator sites.

• Review monitoring visit reports and conduct co-monitoring and evaluation visits as necessary.

• Consistently prepare accurate and timely monitoring visit reports that document site-related issues, resolutions, actions taken, protocol deviations, study progress, and enrollment status.

• Maintain regular communication with study sites to ensure compliance with protocols and Good Clinical Practice (GCP), assess patient accrual rates, and respond to sponsor requests.

• Engage in internal, client/sponsor, scientific, and other required meetings.

⛳️ Requirements

• US: Bachelor's degree (BS/BA) from an undergraduate institution, preferably in life sciences or a related field.

• US: A minimum of 3 years of experience in the pharmaceutical/biotechnology/CRO industry, including 2 years of clinical monitoring experience with at least 1 year in a management role.

• EU: At least 2 years of clinical monitoring experience within the pharmaceutical/biotechnology/CRO sector, with the ability to independently manage monitoring activities.

• US: Permanent authorization to work in the United States.

• EU: Certified Monitor in accordance with the Italian CRO decree dated November 15, 2011.

• EU: Degree in a scientific health field.

• Proficient in English, both written and verbal.

• Proficient in the local language, both written and verbal, in the country where monitoring activities are conducted.

• Understanding of clinical research, ICH GCP, and local regulations.

• Familiarity with regulatory and ethical requirements.

🏝️ Benefits

• Opportunities for professional development.

• Global travel opportunities.

• Flexible work arrangements.