Clinical Research Associate I (Remote, Madrid)

About the role

AbbVie is hiring a Clinical Research Associate I for a remote position in Madrid. The role monitors clinical investigative sites carrying out AbbVie clinical studies so that protocols are executed successfully and in line with regulations, Good Clinical Practice (GCP) and company standards. It covers site visits, data quality, subject safety and investigator management.

Key responsibilities

• Monitor site activities related to AbbVie clinical studies to ensure protocol execution and adherence to federal and local regulations, GCP, ICH Guidelines, AbbVie SOPs, monitoring plans and quality standards.
• Carry out site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies.
• Oversee site personnel without direct authority, motivate them to meet study objectives, manage the site and ensure regulatory inspection readiness.
• Ensure timely, high-quality data submission and follow-up on all safety events.
• Protect study subjects by complying with the monitoring plan, SOPs, ICH Guidelines and applicable regulations.
• Train site personnel on the protocol and regulatory requirements with project team members.
• Manage investigator payments according to contracts, negotiate investigator/hospital agreements and maintain expense reports.
• Identify, evaluate and recommend potential investigators and sites.

Required profile

• Appropriate tertiary qualification in a health-related field (Medical, Scientific, Nursing) preferred, with a Clinical Trials Master's degree.
• At least 1 year of clinically related experience, preferably 6 months in independent clinical research monitoring or as a Study Coordinator.
• On-site monitoring of investigational drug or device trials is required.
• In-depth knowledge of therapeutic indications relevant to clinical trials and of clinical research regulations, ICH/GCP guidelines and applicable laws.
• Strong planning, organizational, analytical and communication skills, able to handle competing projects and deadlines.