Remote Clinical Research Associate – Austria

Syneos Health, Inc.; Österreich; Remote; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Syneos Health in Austria is seeking a remote CRA to monitor sponsor sites under a single-client framework. Responsibilities include site qualification, initiation, monitoring, and close-out visits, performed on-site or remotely, with emphasis on ICH-GCP compliance and data integrity.

The role requires an Austrian monitoring background, fluency in German and English, and travel as needed. You will support ISF/TMF alignment, IP handling, and audit readiness while collaborating with site personnel

Qualifikationen

• 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 Austria
• Must demonstrate good computer skills and be able to embrace new technologies
• Fluency in German and English
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel for montoring visits in Austria

Aufgaben

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
• Per the CMP/SMP: Assesses site processes. Conducts Source Document Review of site documents. Verifies clinical data in CRF is accurate and complete.
• May perform IP inventory, reconciliation and reviews storage and security per protocol.
• Routinely reviews ISF for accuracy and reconciles with TMF.
• Documents activities and supports recruitment, retention and tracking in systems.
• Understands project scope, budgets, timelines; manages site-level activities to meet objectives.
• Acts as liaison with study site personnel and ensures training/compliance.
• Prepares for Investigator Meetings and sponsor meetings; participates in training sessions.
• Supports audit readiness and follows up on required actions.
• Maintains knowledge of ICH/GCP Guidelines and completes required training.

Kenntnisse

German language

English language

Communication skills

Computer skills

Ausbildung

Bachelor’s degree or RN in related field

Jobbeschreibung

Syneos Health in Austria is seeking a remote CRA to monitor sponsor sites under a single-client framework. Responsibilities include site qualification, initiation, monitoring, and close-out visits, performed on-site or remotely, with emphasis on ICH-GCP compliance and data integrity.

The role requires an Austrian monitoring background, fluency in German and English, and travel as needed. You will support ISF/TMF alignment, IP handling, and audit readiness while collaborating with site personnel