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Clinical Research Associate
Syneos Health
Sponsorship not confirmed
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About the job
Syneos Health · DNK-Remote Syneos Health is seeking an experienced Clinical Research Associate (CRA) to join their team in Denmark. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance. Key responsibilities include: Evaluating the overall performance of site and site staff, providing recommendations, and escalating serious issues to the project team Verifying the process of obtaining informed consent, protecting subject/patient confidentiality, and assessing factors affecting subject/patient safety and clinical data integrity Conducting site monitoring, source document review, and verifying clinical data entry in case report forms Managing investigational product inventory, reconciliation, and storage and security Reviewing investigator site files, reconciling contents with trial master files, and ensuring compliance with archiving requirements Documenting activities, supporting subject/patient recruitment and retention, and entering data into tracking systems The ideal candidate will have: A Bachelor's degree or RN in a related field or equivalent experience Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements Previous monitoring experience and excellent communication, presentation, and interpersonal skills Fluency in Danish and English, with a good understanding of Swedish and Norwegian Ability to manage required travel of up to 75% on a regular basis Syneos Health offers a dynamic and supportive work environment, opportunities for career development and progression, and a range of benefits and rewards.
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