Clinical Research Associate

We are seeking an experienced Clinical Research Associate to join our team in Denmark. As a Clinical Research Associate, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
• Assess factors that might affect subject/patient safety and clinical data integrity at an investigator/physician site.
• Conduct source document review of appropriate site source documents and medical records.
• Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
• Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary.
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
• Verify site compliance with electronic data capture requirements.

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Previous monitoring experience in Denmark.
• Excellent communication, presentation, and interpersonal skills.
• Fluency in Danish and proficient in English.
• Ability to manage required travel on a regular basis throughout Denmark and occasionally in the wider Nordics region.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.