Clinical Research Associate – Oncology, Hematology

Jobtailor; Deutschland; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks an experienced Clinical Research Associate to conduct site qualification, initiation, interim monitoring and close-out visits. You will mentor junior CRAs and site staff while ensuring protocol adherence and patient safety.

You will document findings, perform source data verification, review CRFs, and keep the Trial Master File up to date. Proficiency in MS Office, CTMS and EDC is required, with 2+ years of CRA experience and willingness to travel.

Qualifikationen

• Fluent English communication skills, both written and spoken.
• Strong organizational abilities with high attention to detail.
• Ability to work with minimal supervision in a fast-paced, regulated environment.
• Experience with oncology/hematology trials is preferred.

Aufgaben

• Conduct site qualification, initiation, interim monitoring, and close-out visits.
• Mentor and guide less experienced CRAs and site staff as needed.
• Document site visit findings in written reports.
• Train site staff on protocol adherence and safety.
• Review subject safety information and informed consent during visits.
• Perform source data verification for safety, compliance, and data accuracy.
• Review CRFs and assist with data query resolution.
• Update TMF with site documentation and study files.
• Ensure product accountability and return/destruction where applicable.
• Conduct accompanied visits to train other CRAs.

Kenntnisse

Interpersonal skills

Oral communication

Written communication

Attention to detail

Independent work

Ausbildung

4-year university degree

RN/BSN in Nursing

Tools

Microsoft Office

CTMS

EDC Systems

Jobbeschreibung

Site Visit & Monitoring Responsibilities

• Conduct 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
• Review study subject safety information and informed consent
• Conduct source document verification for compliance, patient safety, and data veracity
• Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
• Update site-related documentation for filing in the Trial Master File (TMF)
• 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 English
• Superior organizational skills with attention to details
• Ability to work with little or no supervision
• Proficiency in Microsoft Office, CTMS and EDC Systems
• 2+ years of experience as a Clinical Research Associate
• 4-year university degree or RN/BSN in Nursing
• Experience in Oncology and Hematology is required
• Willingness to travel required

Core Competencies

Demonstrates expertise in conducting site visits, ensuring compliance with protocols, and mentoring clinical research staff. Proficient in data management and documentation within clinical trials, particularly in Oncology and Hematology.

Highest-signal resume keywords

• Clinical Research Associate Experience
• Oncology Experience
• Hematology Experience
• Proficiency in Microsoft Office
• CTMS and EDC Systems Knowledge

Hard Skills

• Site Qualification
• Site Management
• Source Document Verification
• Data Query Resolution
• Protocol Adherence Training
• Trial Master File Documentation
• Patient Safety Monitoring
• Informed Consent Review
• Interim Monitoring
• Study Close-Out Visits

Soft Skills

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

Certifications & Qualifications

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

Industry Keywords

• Clinical Trials
• Investigational Product Compliance
• Site Staff Training
• Study Subject Safety
• Travel Willingness

Tools & Technologies

• Microsoft Office
• CTMS
• EDC Systems