Clinical Research Associate II, Phase I

Fortrea

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

Posted 9/22/2026full-timeRemote • North Carolina • United StatesJuniorMid-Level💰 $105,000 - $118,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Monitoring and Phase I clinical trials, ensuring compliance with regulatory requirements and maintaining high standards of participant care. Proficient in data management systems and capable of managing study sites effectively while adapting to a fast-paced clinical research environment.

Highest-signal resume keywords

Clinical Monitoring ExperiencePhase I ExperienceNursing LicensureData Management SystemsRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementCase Report Form ReviewSerious Adverse Event ReportingSource-Document MonitoringFeasibility WorkEmergency ResponseStudy File MaintenanceData Integrity VerificationMonitoring Study SitesTraining New Employees

Soft Skills

TeamworkAdaptabilityPeople Skills

Tools & Technologies

FortreaElectronic Data EnvironmentComputer Software

Certifications & Qualifications

University DegreeCertification in Allied Health Profession

Industry Keywords

Clinical ResearchPhase I Clinical TrialsRegulatory RequirementsClinical Study SitesProject Coordination

About the role

Key responsibilities & impact

Provide a high standard of care for participants in Phase I clinical trials
Respond to emergency situations according to clinical research standards
Monitor clinical study sites, including routine monitoring and close-out visits
Maintain study files and 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 regulatory requirements
Verify integrity of Case Report Form and other data submitted through source-document monitoring
Monitor data for missing or implausible information
Manage registries and conduct feasibility work when requested
Complete Serious Adverse Event reporting, narratives, reports, and follow-up
Perform CRF review, generate and resolve queries using Fortrea or client 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
Ability to travel overnight 40-50% of the time
Ability to work in a fast-paced, highly regulated clinical research environment
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, fingers, hands, and wrists
Ability to crouch, stoop, bend, and twist upper body and neck
Ability to access and use in-house and off-the-shelf 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
Ongoing application acceptance