Senior CRA, CFSP Specialist – Global Trials

IQVIA; Reading; On-site; GBP 55,000 - 85,000; Full time

Job summary

IQVIA in Reading, United Kingdom is seeking a Senior Clinical Research Associate (CRA) to lead on-site monitoring across PI sites within a cfSP framework. You will ensure patient safety, data integrity, and protocol adherence while building strong investigator relationships.

The role requires 4+ years of on-site monitoring in CRO/pharma settings, solid GCP/ICH knowledge, and the ability to travel up to 40–60% of the time.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 4+ years on-site monitoring experience in CRO/pharma/biotech.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience in a sponsor-dedicated cfSP environment preferred.
• Experience in patient recruitment and study start-up activities preferred.
• Excellent communication, organizational and stakeholder management skills.
• Ability to work independently, manage multiple priorities and collaborate in cross-functional teams.
• Willingness to travel up to 40–60% of time.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits per protocol, GCP, ICH and regulatory requirements.
• Ensure sites maintain patient safety, data integrity and study quality.
• Build and maintain relationships with investigators and site personnel with guidance and support.
• Monitor study progress, regulatory documents, recruitment, data query resolution and site performance metrics.
• Collaborate with sites to optimize patient recruitment and retention.
• Maintain inspection-ready study documentation (ISF, TMF, monitoring reports).
• Identify and escalate study risks, site issues, and quality concerns.
• Partner with cross-functional teams to support study execution and project objectives.
• Mentor junior team members via coaching and co-monitoring where applicable.
• Contribute to continuous improvement and site financial activities.

Skills

Site monitoring

GCP/ICH knowledge

Stakeholder management

Travel readiness

Education

Bachelor's degree in Life Sciences or related

Job description

IQVIA in Reading, United Kingdom is seeking a Senior Clinical Research Associate (CRA) to lead on-site monitoring across PI sites within a cfSP framework. You will ensure patient safety, data integrity, and protocol adherence while building strong investigator relationships.

The role requires 4+ years of on-site monitoring in CRO/pharma settings, solid GCP/ICH knowledge, and the ability to travel up to 40–60% of the time.