Clinical Research Associate II - CFSP

About the role

iQVIA is recruiting a Clinical Research Associate II (CRA II) for its Clinical Functional Service Partnership (CFSP) in Madrid. The CFSP model combines the variety and sponsor-level exposure of being an embedded member of a pharmaceutical or biotechnology team with the stability and career support of iQVIA. The role covers site qualification, initiation, monitoring and close-out, with up to 40-60% travel within the assigned region.

Key responsibilities

• Conduct site qualification, initiation, monitoring and close-out visits according to study protocols, GCP, ICH guidelines and regulatory requirements.
• Ensure sites maintain high standards of patient safety, data integrity, protocol compliance and study quality.
• Build and maintain relationships with investigators and site personnel, providing guidance, training and support.
• Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution and site performance metrics.
• Help sites implement and optimise patient recruitment and retention strategies.
• Maintain accurate, inspection-ready documentation such as Investigator Site Files, Trial Master Files, monitoring reports and follow-up communications.
• Identify, assess and escalate study risks and quality concerns, and mentor junior team members through coaching and co-monitoring.

Required profile

• University degree in Life Sciences, Health Sciences, Nursing, Pharmacy or a related discipline, or equivalent education and experience.
• 1.5 years of on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology or healthcare environment.
• Fluent written and spoken local language (minimum C1) and strong command of English.
• Valid Class B driver's licence and willingness to travel up to 40-60% of working time.
• Preferrable: experience in a sponsor-dedicated or cFSP environment, knowledge of patient recruitment and study start-up.

Required skills

• Strong knowledge of GCP, ICH guidelines and applicable regulatory requirements.
• Excellent communication, organisational and stakeholder management skills.
• Ability to work independently, manage multiple priorities and collaborate in cross-functional teams.