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
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Clinical Research Associate – Oncology, Hematology Arbeitgeber: Jobtailor
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