Senior Clinical Research Associate – Oncology, Hematology

Jobtailor; Deutschland; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Senior Clinical Research Associate in Germany to conduct site qualification, initiation, interim monitoring, site management, and study close-out visits. You will mentor and guide less experienced CRAs and site staff, document site visit findings, and ensure protocol adherence.

The role requires 5+ years as a CRA, a 4-year degree or RN/BSN, travel willingness, and bilingual English/French.

Qualifikationen

• 5+ years of experience as a Clinical Research Associate.
• 4-year university degree or RN/BSN in Nursing.
• Excellent interpersonal, oral, and written communication in English and French.
• Proficiency with CTMS, EDC systems, and Microsoft Office.
• Ability to work with little or no supervision and strong organization.
• Willingness to travel for site visits.

Aufgaben

• Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits
• Mentor and guide 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
• Review study subject safety information and informed consent
• Conduct source document verification for compliance, patient safety, and data accuracy
• Review CRFs using paper or electronic data capture systems
• Assist sites with data query resolution
• Update site-related documentation for filing in the Trial Master File
• Ensure site compliance with investigational product receipt, accountability, and return or destruction
• Conduct accompanied site visits for assessment or training of other CRAs

Kenntnisse

Interpersonal skills

Oral communication

Written communication

Attention to detail

Bilingual English/French

Willingness to travel

Ausbildung

4-year university degree

RN/BSN in Nursing

Tools

CTMS

EDC systems

Microsoft Office

Jobbeschreibung

• Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits
• Mentor and guide 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
• Review study subject safety information and informed consent
• Conduct source document verification for compliance, patient safety, and data accuracy
• Review CRFs using paper or electronic data capture systems
• Assist sites with data query resolution
• Update site-related documentation for filing in the Trial Master File
• Ensure site compliance with investigational product receipt, accountability, and return or destruction
• Conduct accompanied site visits for assessment or training of other CRAs

Requirements

• Excellent interpersonal, oral, and written communication skills in French and English
• Superior organizational skills with attention to detail
• Ability to work with little or no supervision
• Proficiency in Microsoft Office, CTMS, and EDC systems
• 5+ years of experience as a Clinical Research Associate
• 4-year university degree or RN/BSN in Nursing
• Willingness to travel required

Core Competencies

Demonstrates expertise in conducting site visits, monitoring compliance, and training site staff while ensuring adherence to protocols and safety standards. Proficient in managing documentation and utilizing clinical trial management systems to support research activities.

Highest-signal resume keywords

• Clinical Research Associate Experience
• Site Qualification and Management
• Protocol Adherence Training
• Microsoft Office Proficiency
• Bilingual Communication Skills

Hard Skills

• Source Document Verification
• Data Query Resolution
• CRF Review
• Study Safety Information Review
• Trial Master File Documentation

Soft Skills

• Interpersonal Skills
• Organizational Skills
• Attention to Detail
• Written Communication Skills
• Oral Communication Skills

Certifications & Qualifications

• 4-Year University Degree
• RN/BSN in Nursing

Industry Keywords

• Clinical Trials
• Site Management
• Patient Safety
• Investigational Product Compliance
• Study Close-Out

Tools & Technologies

• CTMS
• EDC Systems
• Microsoft Office