Clinical Research Associate II, Phase I

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

📋 Description

• Deliver exceptional care to participants involved in clinical trials.

• Respond promptly to emergencies in accordance with clinical research protocols.

• Execute routine monitoring and closure of clinical study sites.

• Maintain comprehensive study documentation.

• Conduct pre-study assessments and initiation visits.

• Collaborate with vendors.

• Oversee study sites in alignment with project objectives.

• Ensure study personnel receive adequate resources and instructions for safely enrolling participants.

• Verify that informed consent processes and protocol stipulations adhere to relevant regulatory standards.

• Safeguard data integrity in Case Report Forms and other data collection instruments.

• Monitor data for any missing or implausible entries.

• Manage study registries and perform feasibility assessments as needed.

• Complete reporting, narratives, and follow-ups for Serious Adverse Events.

• Carry out CRF reviews and generate as well as resolve queries using Fortrea or client data management systems.

• Assist in training new team members through co-monitoring.

• Coordinate specific clinical projects as a Local Project Coordinator, under supervision when required.

• Serve as a local client liaison when designated.

• Execute additional tasks as directed by management.

• Travel extensively to client and site locations, including occasional domestic and international trips.

⛳️ Requirements

• Bachelor’s degree or certification in a relevant allied health field from an accredited institution (e.g., nursing licensure).

• Minimum of 1 year of Clinical Monitoring experience.

• Experience in Phase I trials.

• Willingness to undertake 40-50% overnight travel.

• Comfort in a fast-paced environment with shifting priorities, teamwork focus, and technology-driven processes.

• Ability to remain seated for long durations and operate a vehicle safely.

• Capability for repetitive hand movements with both hands, including quick, simple motions of fingers, hands, and wrists.

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

• Proficiency in accessing and using various in-house and commercial software applications.

• Ability to lift and transport objects, luggage, and a laptop weighing up to 15-20 lbs.

• Consistent and regular attendance.

• Flexibility in working hours may be necessary.

🏝️ Benefits

• Opportunity for remote work.

• 40-50% overnight travel.

• Continuous acceptance of applications.