Clinical Research Associate II Germany

Premier Research; Deutschland; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

Premier Research is seeking a Clinical Research Associate II to conduct monitoring of assigned trials in compliance with protocol, ICH-GCP/ISO14155 and local laws. The role manages study site activities to ensure timely, accurate data collection and proactive risk mitigation. You may oversee multiple studies, working independently with team support.

Candidates must reside in Germany and be fluent in German, with country-wide monitoring and on-site duties as required.

Qualifikationen

• Undergraduate degree or international equivalent in clinical, science, or health-related field, or a licensed health-care professional (RN) required
• Previous clinical research experience required
• At least 4+ years’ experience in clinical trials and independent monitoring
• Experience across therapy areas: Neurology, Oncology, Rare Disease and Pediatrics
• Preference for experience across all phases I-IV; Phase II/III only will be considered

Aufgaben

• Conduct monitoring activities in compliance with protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards.
• Manage study site activities to ensure the collection of accurate clinical data within given timelines.
• Identify, resolve/mitigate and escalate risks and/or issues, may be responsible for multiple studies and must work independently with team support.

Jobbeschreibung

The Clinical Research Associate II (CRA II) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. This role performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA II proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.

Qualifications

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Previous clinical research experience required
• At least 4+ years’ experience in clinical trials and independent monitoring
• Experience working ideally across all, if not some, of the following therapy areas;Neurology, Oncology, Rare Disease and Pediatrics
• Preference at working across all phases I-IV, although phase II and III only will be considered

There will be an expectation for country-wide monitoring with the average frequency of days on site being 6 days per month.

You must be located in Germany to be considered for this position and be fluent in German