Clinical Research Associate II, Phase I

Fortrea

. Provide a high standard of care for participants in clinical trials .

Posted 9/15/2026full-timeRemote • Colorado • United StatesJuniorMid-Level💰 $100,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Monitoring and adherence to study protocols, ensuring compliance with regulations and maintaining data integrity. Proficient in managing clinical trials, conducting site visits, and training staff within a fast-paced environment.

Highest-signal resume keywords

Clinical Monitoring ExperiencePhase I ExperienceInformed Consent ProceduresData Management SystemsClinical Trial Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementCRF ReviewSerious Adverse Event ReportingFeasibility WorkStudy Protocol Compliance

Soft Skills

TeamworkAdaptabilityPeople Skills

Tools & Technologies

Electronic Data EnvironmentComputer Software Proficiency

Certifications & Qualifications

Nursing LicensureAllied Health Profession Certification

Industry Keywords

Clinical TrialsStudy MonitoringEmergency ResponseVendor LiaisonStudy Site Management

About the role

Key responsibilities & impact

Provide a high standard of care for participants in clinical trials
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
Verify informed consent procedures and protocol requirements comply with applicable regulations
Monitor source documents and verify the integrity of CRF and other collected data
Manage clinical registries and undertake feasibility work
Complete Serious Adverse Event reporting, narratives, reports, and follow-up
Perform CRF review and generate and resolve queries in data management systems
Assist with training new employees through co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator
Act as a local client contact when assigned
Perform other duties assigned by management

Requirements

What you’ll need

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
Comfortable working in a fast-paced environment with strict study protocol and timelines
Ability to adapt to constantly 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 and ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Ability to crouch, stoop, bend, and twist the 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

Benefits

Comp & perks

Remote work arrangement
40-50% overnight travel
Occasional domestic and international travel
Ongoing application acceptance