Senior Clinical Research Associate II – Phase I

This is a fully remote position, open to applicants in Florida.

📋 Description

• Deliver exceptional care for participants in clinical trials and respond to emergencies in accordance with clinical research standards.

• Execute all facets of study-site monitoring, which includes routine oversight and closing out clinical sites.

• Maintain study documentation and perform pre-study and initiation visits.

• Collaborate with vendors.

• Oversee clinical sites in alignment with project plans.

• Ensure study personnel receive the necessary materials and guidance for safe patient enrollment.

• Confirm that informed-consent processes and protocol requirements adhere to relevant regulations.

• Review source documents and data to identify any missing or questionable information.

• Manage study registries and conduct feasibility assessments as needed.

• Complete reporting on Serious Adverse Events, including reports, narratives, and follow-ups.

• Conduct CRF reviews, generate queries, and resolve queries within Fortrea or client data management systems.

• Support the training of new employees through co-monitoring activities.

• Coordinate specific clinical projects as a Local Project Coordinator and serve as a local client liaison when assigned.

• Carry out additional tasks as directed by management.

⛳️ Requirements

• A university or college degree, or certification in a related allied health profession from a recognized institution (e.g., nursing licensure).

• A minimum of 1 year of Clinical Monitoring experience.

• Experience in Phase I trials.

• Comfortable working in a dynamic, fast-paced environment that prioritizes teamwork and technology.

• Ability to sit for extended periods and operate a vehicle safely.

• Capacity for repetitive hand movements with both hands, including quick, simple, and repetitive actions of the fingers, hands, and wrists.

• Occasional need for crouching and stooping, along with frequent bending and twisting of the upper body and neck.

• Proficiency in accessing and utilizing various computer software.

• Capability to lift and carry items, including luggage and a laptop weighing up to 15-20 lbs.

• Consistent and regular attendance is required.

• Flexibility in working hours may be necessary.

🏝️ Benefits

• Opportunity for remote work.

• 40-50% overnight travel, including occasional domestic and international trips.

• Continuous acceptance of applications.