Clinical Research Associate II — Onsite Monitoring

IQVIA Inc; Dublin; On-site; EUR 48,000 - 72,000; Full time

Job summary

IQVIA UK’s RWE team is seeking a Clinical Research Associate II to support Phase 3b and Phase 4 studies across a diverse range of therapeutic areas. The CRA will cover sites across UK & Ireland, with 6-7 site visits per month.

You will perform site monitoring visits in line with GCP/ICH, manage recruitment plans, training, and ensure TMF/ISF compliance. This role requires 1–2 years on-site monitoring experience and a degree in a scientific discipline or healthcare.

Qualifications

• 1–2 years on-site monitoring experience.
• Degree in scientific discipline or health care or equivalent.
• Good knowledge of GCP and ICH guidelines.
• Ability to establish and maintain effective working relationships with coworkers and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in accordance with GCP/ICH and contract scope.
• Drive and track subject recruitment plans to support project needs.
• Administer protocol training to sites and maintain regular communication about project expectations and issues.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate quality issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries, and support start-up activities.
• Ensure site documents are filed in TMF and ISF maintained per regulatory requirements.
• Create and maintain site management documentation and visit reports; issue follow-up letters as required.
• Collaborate with study team for project execution.

Skills

Site monitoring

GCP/ICH knowledge

Communication

Relationship building

Education

Science/Healthcare degree

Job description

IQVIA UK’s RWE team is seeking a Clinical Research Associate II to support Phase 3b and Phase 4 studies across a diverse range of therapeutic areas. The CRA will cover sites across UK & Ireland, with 6-7 site visits per month.

You will perform site monitoring visits in line with GCP/ICH, manage recruitment plans, training, and ensure TMF/ISF compliance. This role requires 1–2 years on-site monitoring experience and a degree in a scientific discipline or healthcare.