Responsibilities
- Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards
- Perform routine monitoring and close-out of clinical sites
- Maintain study files
- Conduct pre-study and initiation visits
- Liaise with vendors
- Manage study sites according to project plans
- Ensure study staff receive proper materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements comply with applicable regulatory requirements
- Verify the integrity of data submitted on Case Report Forms and other data collection tools
- Monitor data for missing or implausible data
- Manage registries according to project plans and undertake feasibility work when requested
- Complete Serious Adverse Event reporting, reports, narratives, and follow-up
- Independently perform CRF review, query generation, and resolution using Fortrea or client data management systems
- Assist with training new employees through co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact
- Perform other duties assigned by management
- Travel frequently to client and site locations, including occasional domestic and international travel
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 5+ years of Clinical Monitoring experience
- Oncology experience; early phase preferred
- 30-50% overnight travel
- Comfortable working in a fast-paced environment with strict study protocol and timeline requirements
- Ability to adapt to constantly changing priorities
- Teamwork and people skills
- Ability to work in a technology-based electronic data environment
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching, stooping, frequent bending and twisting of upper body and neck
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Light to moderate lifting and carrying objects including luggage and laptop computer, maximum 15-20 lbs
- Regular and consistent attendance
- Varied hours may be required
Core Competencies
Demonstrates expertise in Clinical Monitoring and Oncology, ensuring compliance with regulatory requirements and maintaining data integrity. Proficient in managing clinical trials, conducting site visits, and training staff in a fast-paced environment.
Highest-signal resume keywords
- Clinical Monitoring Experience
- Oncology Experience
- Regulatory Compliance
- Data Management Systems
- Teamwork and People Skills
ATS Optimization Keywords
Hard Skills
- Clinical Trial Management
- Case Report Form Review
- Serious Adverse Event Reporting
- Data Integrity Verification
- Feasibility Assessment
Soft Skills
- Adaptability
- Teamwork
- Communication
Certifications & Qualifications
- Nursing Licensure
- Allied Health Certification
Industry Keywords
- Clinical Trials
- Oncology
- Study Protocol
- Project Plans
- Vendor Liaison
Tools & Technologies
- Fortrea
- Electronic Data Environment
- Data Collection Tools
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Senior Clinical Research Associate II – Oncology Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
