- 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 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
- Collaborate with colleagues across diverse therapeutic areas and specialties to advance clinical research
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 Neurology and Oncology 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 Neurology and Oncology.
Highest-signal resume keywords
- Clinical Research Associate Experience
- Site Qualification and Management
- Microsoft Office Proficiency
- CTMS and EDC Systems Knowledge
- Neurology and Oncology Experience
Hard Skills
- Site Qualification
- Source Document Verification
- Protocol Adherence Training
- Data Query Resolution
- Clinical Trial Documentation
Soft Skills
- Interpersonal Communication
- Organizational Skills
- Attention to Detail
- Ability to Work Independently
Certifications & Qualifications
- 4-Year University Degree
- RN/BSN in Nursing
Industry Keywords
- Clinical Research
- Trial Master File
- Patient Safety
- Informed Consent
- Therapeutic Areas
Tools & Technologies
- Microsoft Office
- CTMS
- EDC Systems
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Clinical Research Associate – Neurology, Oncology Arbeitgeber: Jobtailor
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