In House Clinical Research Associate II – FSP

Fortrea

. Serve as contact for project teams and investigative sites; conduct and document site contacts .

Posted 11/5/2026full-timeRemote • North Carolina • United StatesJuniorMid-Level💰 $65,000 - $72,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial processes, regulatory compliance, and site management, with a strong focus on ICH-GCP guidelines and effective communication within project teams. Proficient in monitoring site performance, managing documentation, and ensuring adherence to protocol requirements.

Highest-signal resume keywords

Clinical Trial MonitoringICH-GCP GuidelinesSite ManagementRegulatory ComplianceProject Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Case Report Form ReviewData Management SystemsPatient Recruitment TrackingSite Performance MonitoringRegulatory DocumentationIVRS/IWRS ReviewCTMS Data EntryAction Plan ImplementationQuery GenerationDrug Accountability

Soft Skills

Communication SkillsProblem-Solving SkillsTime ManagementOrganizational SkillsTeam Collaboration

Tools & Technologies

CTMSData Management SystemsRemote Monitoring ToolsLaboratory Sample Management

Certifications & Qualifications

Nursing LicensureMedical Technology CertificationLaboratory Technology Certification

Industry Keywords

Clinical ResearchPharmaceutical IndustryCRO IndustryEthics Committee SubmissionsRegulatory Authority Notifications

About the role

Key responsibilities & impact

Serve as contact for project teams and investigative sites; conduct and document site contacts
Monitor site performance and implement action plans with the CRA
Track patient recruitment and discuss study risks and opportunities with the Project Manager and CTL
Assist CRAs with site visit preparation, report generation, file QC, and action-item resolution
Oversee site maintenance activities, renewals, and regulatory/IRB/IEC documentation
Perform Case Report Form review, query generation, and resolution in data management systems
Assist with on-site monitoring tasks, including CRF review, SDR/SDV, regulatory files, and drug accountability
Perform remote monitoring visits, including SDV/SDR after MEA training
Liaise with laboratories, sponsors, medical monitors, project teams, CTAs, and sites
Provide site training via phone or web meetings
Conduct IVRS/IWRS review and reconciliation
Coordinate study visits and shipment of drug and laboratory samples
Manage site compliance with protocol requirements, visits, and timelines
Distribute and track clinical trial supplies
Enter weekly study details in CTMS and assist with status reports
Assist with Ethics Committee and Regulatory Authority submissions and notifications
Facilitate translation and back translation of study documents
Attend and present at investigator, sponsor, kick-off, and face-to-face meetings
Ensure compliance with Fortrea SOPs, regulatory requirements, ICH-GCP, and applicable guidelines
Complete the Fortrea Monitoring Excellence Academy training program
Perform other project-related administrative duties as assigned

Requirements

What you’ll need

University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology)
In lieu of the above requirement, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
Basic understanding of ICH-GCP guidelines
Basic understanding of the clinical trial process
A minimum of 2 years of industry experience in a related role
Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
Ability to work within a project team
Good planning, organization, time management and problem-solving skills
Good communication skills, oral and written
General computer literacy
Ability to work efficiently and effectively in a matrix environment
Ability to sit for extended periods and operate a vehicle safely
Ability to use a variety of computer software
Light to moderate lifting and carrying of objects up to 15–20 lbs
Regular and consistent attendance
Varied hours may be required