Clinical Research Associate II, Phase

• Provide a high standard of care for participants in clinical trials
• Respond to emergency situations based upon clinical research standards
• Conduct 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 enroll patients
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Ensure integrity of data submitted on CRFs and other data collection tools
• Monitor data for missing or implausible data
• Manage study registries according to project plans
• Undertake feasibility work when requested
• Complete SAE reporting, reports, narratives, and follow-up of SAEs
• Perform CRF review and query generation and resolution in Fortrea or client data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator, with supervision if applicable
• Act as a local client contact as assigned
• Perform other duties assigned by management

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 1+ years of Clinical Monitoring experience
• Phase I experience
• 40-50% overnight travel
• Ability to work in a fast-paced environment with strict study-protocol timelines
• Ability to adapt to changing priorities
• Teamwork and people skills
• Comfort working 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 ability to make fast, simple, repeated movements of fingers, hands, and wrists
• Ability to crouch, stoop, bend, and twist upper body and neck
• Ability to access and use a variety of computer software
• Ability to lift and carry 15-20 lbs.
• Regular and consistent attendance
• Varied hours may be required

Demonstrates expertise in Clinical Monitoring and Project Coordination, ensuring compliance with clinical research standards and effective management of study sites. Proficient in data integrity verification and participant care within clinical trials.

• Clinical Monitoring Experience
• Phase I Experience
• Nursing Licensure
• Data Management Systems
• Emergency Response

• Clinical Trial Management
• Data Collection Tools
• CRF Review
• SAE Reporting
• Feasibility Assessment
• Study Protocol Compliance
• Monitoring Data Integrity
• Study Site Management
• Patient Enrollment Procedures
• Vendor Liaison

• Teamwork
• Adaptability
• Communication Skills
• People Skills
• Time Management

• University Degree
• Certification in Allied Health Profession

• Clinical Trials
• Clinical Research Standards
• Informed Consent Procedures
• Study Files Maintenance
• Project Plans

• Electronic Data Environment
• Fortrea
• Data Management Systems