Clinical Research Associate - Germany | Neurology & Oncology

Worldwide Clinical Trials; USA; Remote; USD 75.000 - 115.000; Vollzeit

Zusammenfassung

Worldwide Clinical Trials in the United States seeks a Clinical Research Associate to support site qualification, monitoring, and study close-out visits across diverse therapeutic areas. You will travel as needed and collaborate with site staff to ensure compliance and data integrity.

In this role you will mentor junior CRAs, document findings, review safety information, and coordinate TMF management with data teams and sponsors, fostering quality and patient safety throughout trials.

Qualifikationen

• 2+ years of experience as a Clinical Research Associate.
• 4-year university degree or RN/BSN in Nursing.
• Experience in Neurology, Oncology and Hematology is required.
• Willingness to travel.

Aufgaben

• Responsible for site qualification, initiation, interim monitoring, site management, and study close-out visits.
• Provide mentoring and guidance to less experienced CRAs and site staff when needed.
• Document site visit findings via written reports.
• Assess, monitor, and train study site staff on protocol adherence as required.
• Review study subject safety information and informed consent.
• Conduct source document verification for compliance, patient safety, and veracity of data.
• Review CRFs using paper or electronic data capture systems and assist sites with data query resolution.
• Provide applicable updates for site related documentation for filing in the Trial Master File (TMF).
• Ensure site compliance with IP receipt, accountability and return or destruction.
• Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate.

Kenntnisse

Interpersonal skills

Oral communication

Written communication

English

Ausbildung

Bachelor's degree

RN/BSN

Tools

Microsoft Office

CTMS

EDC Systems

Jobbeschreibung

Worldwide Clinical Trials in the United States seeks a Clinical Research Associate to support site qualification, monitoring, and study close-out visits across diverse therapeutic areas. You will travel as needed and collaborate with site staff to ensure compliance and data integrity.

In this role you will mentor junior CRAs, document findings, review safety information, and coordinate TMF management with data teams and sponsors, fostering quality and patient safety throughout trials.