Clinical Research Associate I

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

📋 Description

• Oversee activities performed by clinical investigative sites for AbbVie clinical trials

• Ensure adherence to protocols, regulatory standards, GCP/ICH Guidelines, AbbVie SOPs, monitoring plans, and quality benchmarks

• Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 trials

• Supervise site personnel activities and inspire or influence them to achieve study goals

• Proactively manage sites and execute action plans to guarantee compliance and readiness for inspections

• Ensure the quality and prompt submission of study-site data, including safety-event reporting and follow-up procedures

• Safeguard the well-being and protection of study subjects by adhering to monitoring plans, SOPs, guidelines, and regulatory requirements

• Educate study-site personnel on protocols and regulatory obligations

• Manage payments to investigators and negotiate agreements with investigators/hospitals

• Complete expense reports in accordance with applicable guidelines

• Identify, assess, and recommend potential investigators and clinical sites

⛳️ Requirements

• Relevant tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Nursing) is preferred

• A Master’s Degree in Clinical Trials is preferred

• At least 1 year of experience in a clinically related role

• Ideally, 6 months of independent clinical research monitoring or Study Coordinator experience

• Required experience in on-site monitoring of investigational drug or device trials

• Comprehensive knowledge of therapeutic indications pertinent to clinical trials

• Extensive understanding of clinical research regulations, ICH/GCP Guidelines, and related regulations

• Excellent planning and organizational abilities

• Capability to work effectively and efficiently in a fast-paced environment with multiple projects and deadlines

• Ability to comprehend and adhere to work processes within the designated function

• Strong analytical and conceptual skills

• Effective interpersonal skills and clear communication abilities

• Capacity to address clinical site issues with appropriate guidance and initiate corrective actions

• Ability to apply functional expertise and exercise sound judgment

🏝️ Benefits

• Employees have the option to work remotely

• Equal opportunity employer

• Commitment to integrity, innovation, life transformation, and community service