Senior CRA: Global Trials, Mentoring, Travel 40-60%

IQVIA Holdings Inc.; Reading; On-site; GBP 55,000 - 75,000; Full time

Job summary

IQVIA is seeking a Senior Clinical Research Associate (CRA) to conduct site qualification, initiation, monitoring and close-out visits in line with GCP, ICH guidelines and regulatory requirements. You will ensure patient safety, data integrity and protocol compliance across study sites in the UK.

You will train site personnel, track study progress, manage regulatory documents, and collaborate with cross-functional teams to drive study delivery.

Qualifications

• University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or related discipline, or equivalent combination of education and experience.
• 4 years minimum on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology, or healthcare environment.
• Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
• Preferrable experience in a sponsor-dedicated or cFSP environment.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
• Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.
• Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.
• Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.
• Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.
• Maintain accurate, complete, and inspection-ready study documentation, including ISF, TMF, monitoring reports, and follow-up communications.
• Identify, assess, and appropriately elevate study risks, site issues, and quality concerns while driving timely resolution.
• Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives.
• Mentor and support junior clinical team members through coaching, training, and co-monitoring activities.

Skills

GCP knowledge

ICH guidelines

Regulatory compliance

Communication

Education

University degree in Life Sciences or related discipline

Job description

IQVIA is seeking a Senior Clinical Research Associate (CRA) to conduct site qualification, initiation, monitoring and close-out visits in line with GCP, ICH guidelines and regulatory requirements. You will ensure patient safety, data integrity and protocol compliance across study sites in the UK.

You will train site personnel, track study progress, manage regulatory documents, and collaborate with cross-functional teams to drive study delivery.