
Clinical Research Associate II, Phase I
Posted 10 hours ago

Posted 10 hours ago
This is a fully remote position, open to applicants in Florida.
• Deliver exemplary care to participants involved in clinical trials
• Address emergency situations in accordance with clinical research protocols
• Oversee clinical study sites through routine monitoring and close-out visits
• Maintain study documentation and conduct both pre-study and initiation visits
• Collaborate with vendors
• Manage sites in alignment with project plans
• Ensure study personnel receive the necessary materials and guidance
• Validate informed consent processes and adherence to protocols
• Safeguard the integrity of CRF and additional data through source-document monitoring
• Review data for any missing or questionable information
• Handle clinical registries and perform feasibility assessments
• Complete SAE reporting, including narratives and follow-up reports
• Conduct CRF reviews and generate as well as resolve queries within Fortrea or client data management systems
• Support the training of new employees through co-monitoring
• Coordinate specific clinical projects as a Local Project Coordinator
• Serve as a local client liaison when designated
• Execute other responsibilities assigned by management
• A university or college degree, or certification in a relevant allied health profession from an accredited institution (e.g., nursing licensure)
• A minimum of 1 year of Clinical Monitoring experience
• Experience in Phase I clinical trials
• Willingness to undertake 40-50% overnight travel
• Capability to thrive in a fast-paced, dynamic, teamwork-oriented, technology-driven environment
• Ability to remain seated for extended durations and operate a vehicle safely
• Repetitive hand movements with both hands, capable of making quick, simple, repetitive motions with fingers, hands, and wrists
• Occasional crouching, stooping, bending, and twisting of the upper body and neck
• Proficiency in accessing and utilizing both in-house and commercial computer software
• Capacity to lift and carry weights of 15-20 lbs.
• Consistent and regular attendance is expected
• Flexibility in working hours may be required
• 40-50% overnight travel
• Regular travel to client and site locations, including occasional domestic and international trips
Fortrea
AbbVie
ICON plc
AbbVie
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