Clinical Research Associate II: Site Monitoring

IQVIA LLC; Eccles; On-site; GBP 30,000 - 42,000; Full time

Job summary

IQVIA UK's Site Management team is seeking junior and experienced Clinical Research Associates to perform on-site monitoring visits across diverse sites, ensuring GCP/ICH compliance and protocol adherence.

The role involves coordinating subject recruitment plans, training sites on the protocol, maintaining regular communication, and managing regulatory submissions, ISF/TMF, and data queries while supporting start-up activities when needed.

Qualifications

• Experience of independent on-site monitoring.
• Managed multiple clinical trial protocols across diverse sites.
• Strong knowledge of GCP and ICH guidelines.
• Bachelor's degree in life sciences or equivalent.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH.
• Collaborate with sites to drive subject recruitment plans.
• Train sites on the protocol and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory compliance.
• Escalate quality issues as appropriate.
• Track regulatory submissions, recruitment, CRF completion, data queries.
• Support start-up phase if needed.
• Maintain Trial Master File and ISF per regulatory requirements.
• Generate visit reports and action letters.
• Collaborate with study team for project execution.

Skills

On-site monitoring

Site management

GCP/ICH knowledge

Travel flexibility

Education

Life science degree

Job description

IQVIA UK's Site Management team is seeking junior and experienced Clinical Research Associates to perform on-site monitoring visits across diverse sites, ensuring GCP/ICH compliance and protocol adherence.

The role involves coordinating subject recruitment plans, training sites on the protocol, maintaining regular communication, and managing regulatory submissions, ISF/TMF, and data queries while supporting start-up activities when needed.