Senior Clinical Research Associate II – Denmark (Remote)

Syneos Health; Winterthur; Vor Ort; CHF 76.000 - 114.000; Vollzeit

Zusammenfassung

Syneos Health is seeking a Clinical Research Associate II / Sr CRA I to support sponsor-dedicated studies in Denmark. You will perform site qualification, initiation and monitoring visits, ensure GCP compliance and manage site relationships throughout the study lifecycle.

The role requires strong communication, attention to data quality and regulatory standards, with travel up to 65–75% and a focus on patient safety. Oncology experience is a plus.

Qualifikationen

• Bachelor’s degree or RN in related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
• Excellent communication, presentation and interpersonal skills.

Aufgaben

• Performs site qualification, initiation, interim monitoring and close-out visits (on-site or remote) with regulatory and GCP compliance.
• Verifies informed consent processes and protects subject confidentiality; assesses safety and data integrity factors.
• Conducts Source Data Review, data verification and query resolution to ensure timely closure.
• Manages IP inventory, labeling, and storage in line with protocol and regulations.
• Maintains ISF/TMF accuracy and supports site staff training on applicable SOPs.
• Prepares for Investigator Meetings and contributes to audit readiness and follow-up actions.

Kenntnisse

Excellent communication & presentation

GCP/ICH knowledge

Data integrity & QA

Travel readiness

Computer literacy

Ausbildung

Bachelor’s degree or RN in related field

Jobbeschreibung

Syneos Health is seeking a Clinical Research Associate II / Sr CRA I to support sponsor-dedicated studies in Denmark. You will perform site qualification, initiation and monitoring visits, ensure GCP compliance and manage site relationships throughout the study lifecycle.

The role requires strong communication, attention to data quality and regulatory standards, with travel up to 65–75% and a focus on patient safety. Oncology experience is a plus.