Denmark Clinical Research Associate — Site Monitoring

IQVIA; København; On-site; DKK 500,000 - 700,000; Full time

Job summary

IQVIA LLC is seeking an Experienced CRA to Denmark to perform site monitoring and study management duties in accordance with GCP, ICH, and sponsor requirements. You will lead monitoring visits, support recruitment planning, and ensure regulatory and TMF/ISF documentation is maintained across assigned sites.

The role requires a Bachelor’s degree in a scientific or healthcare field and at least 2 years of on-site monitoring experience, with strong Danish and English communication skills.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted.
• Good knowledge of GCP and ICH guidelines.
• Proficiency in Microsoft Word, Excel and PowerPoint; comfortable using a laptop and mobile devices.
• Written and verbal communication in Danish and English.
• Strong organizational, problem-solving, time and financial management skills.
• Ability to establish and maintain effective working relationships.

Responsibilities

• Perform site monitoring visits (initiation, routine monitoring, and close-out) per scope and GCP.
• Drive and track subject recruitment plans in line with project needs.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track submissions, recruitment, CRF completion, data queries; support startup as needed.
• Maintain TMF and ISF documentation per regulatory requirements.
• Collaborate with study team for project execution and site support.
• Support site financial management and invoicing where applicable.

Skills

On-site monitoring

GCP/ICH knowledge

MS Office proficiency

Danish & English language

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

IQVIA LLC is seeking an Experienced CRA to Denmark to perform site monitoring and study management duties in accordance with GCP, ICH, and sponsor requirements. You will lead monitoring visits, support recruitment planning, and ensure regulatory and TMF/ISF documentation is maintained across assigned sites.

The role requires a Bachelor’s degree in a scientific or healthcare field and at least 2 years of on-site monitoring experience, with strong Danish and English communication skills.