CRA II Denmark - Site Monitoring & Coordination

Syneos Health Denmark ApS

Denmark

Remote

DKK 550,000 - 750,000

Full time

12 days ago

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Job summary

Syneos Health Denmark ApS is seeking a Clinical Research Associate II/ Sr CRA I to support sponsor-dedicated studies in Denmark. The role involves hands-on monitoring, site initiation, regulatory compliance, and collaboration with cross-functional teams to ensure data integrity and patient safety.

The successful candidate will demonstrate strong communication, problem-solving, and travel readiness for up to substantial site visits.

Qualifications

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
Oncology experience will be a plus.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Excellent computer skills and ability to embrace new technologies.

Responsibilities

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH‑GCP and/or GPP and protocol compliance.
Communicates/escalates serious issues to the project team and develops action plans.
Maintains a working knowledge of ICH/GCP Guidelines and related regulations.
Verifies informed consent processes and documents for each subject/patient as required.
Supports site staff in data integrity, query resolution and site monitoring activities.