Clinical Trial Coordinator – Regulatory

Fortrea

. Serve as contact for the project team and investigative sites .

Posted 11/12/2026full-timeRemote • United StatesJunior💰 $65,000 - $75,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research processes, including site monitoring, compliance with protocol requirements, and effective communication with project teams and investigative sites. Proficient in managing clinical trial supplies and utilizing data management systems for case report form review and query resolution.

Highest-signal resume keywords

Clinical Research ExperienceSite MonitoringProtocol ComplianceData Management SystemsCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Case Report Form ReviewQuery GenerationQuery ResolutionSite Performance MonitoringStudy Visit CoordinationCTMS Data EntryBiology UnderstandingSOP ComplianceICH Guidelines KnowledgeGCP Knowledge

Soft Skills

Organizational SkillsTime ManagementInterpersonal SkillsWritten CommunicationOral Communication

Tools & Technologies

CTMSData Management SystemsComputer Software

Certifications & Qualifications

University/College Degree in Life ScienceNursing CertificationMedical Technology CertificationLaboratory Technology Certification

Industry Keywords

Clinical TrialsInvestigative SitesEthics CommitteesRegulatory AuthoritiesClinical Research

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as contact for the project team and investigative sites
Conduct and document site contacts for assigned sites according to study guidelines, including creating contact reports for telephone sessions
Monitor site performance and implement action plans with the CRA for sites not meeting expectations
Assist CRAs with site visit preparation by running reports, quality-checking files, and resolving prior action items
Perform Case Report Form review, query generation, and query resolution under supervision on Fortrea or client data management systems
Assist with coordinating study visits and shipment of drug, ancillary supplies, and laboratory kits/samples
Manage sites to ensure subject compliance with protocol requirements, study visits, and timelines
Distribute and track clinical trial supplies and ensure sites have sufficient supplies for recruitment
Coordinate maintenance activities, including amendments and revised documents, for assigned sites
Enter weekly study details in CTMS as required
Assist with submissions and notifications to Ethics Committees and Regulatory Authorities
Facilitate translation and back translation of required documents for local country requirements
Attend and present at investigator, sponsor, kick-off, and face-to-face meetings as needed

Requirements

What you’ll need

At least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing)
1-2 years of clinical research is required
Basic understanding of biology and biological processes
Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
Good organizational and time management skills
Good communication skills, oral and written
General computer literacy
Ability to work efficiently and effectively in a matrix environment
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
Ability to sit for extended periods and operate a vehicle safely
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Light to moderate lifting and carrying objects including luggage and laptop computer with a maximum lift of 15-20 lbs
Regular and consistent attendance
Varied hours may be required