Clinical Research Associate

Extremity Care

. Oversee operational aspects of clinical trial conduct at investigational sites .

Posted 9/29/2026full-timeRemote • United StatesJuniorMid-Level💰 $80,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in overseeing clinical trial operations, ensuring compliance with ICH-GCP and FDA regulations, and managing site performance metrics. Proficient in developing monitoring plans, coordinating data management activities, and maintaining effective communication with trial staff and investigators.

Highest-signal resume keywords

Clinical Trial OversightICH-GCP ComplianceCRA Certification (CCRA or CCRP)Data Management CoordinationSite Performance Metrics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research MethodologyMonitoring Plan DevelopmentData Query ProcessingCRF DevelopmentProtocol DraftingSite Activation ProcessesPatient Enrollment TrackingAdverse Event ReportingStudy Status ReportingRegulatory Compliance

Soft Skills

Strong Organizational AbilitiesProblem-Solving SkillsEffective CommunicationIndependent and Collaborative WorkAttention to Detail

Tools & Technologies

Microsoft Office (Word, Excel, PowerPoint)

Certifications & Qualifications

CRA Certification (CCRA or CCRP)

Industry Keywords

FDA RegulationsICH GuidelinesISO StandardsCGMP/CGTPAATB StandardsClinical Trial SitesInvestigational SitesSite QualificationSite MonitoringStudy Protocols

About the role

Key responsibilities & impact

Oversee operational aspects of clinical trial conduct at investigational sites
Evaluate clinical trial resourcing for site qualification, initiation, monitoring, and site support
Work with multiple trial sites and studies across varying indications
Develop and maintain monitoring plans
Liaise with clinic and hospital investigators and trial staff
Oversee trial site setup and ensure appropriate trial materials are available
Oversee site activation processes
Develop and monitor metrics evaluating monitor and site performance
Review data for issues or inconsistencies in collection or monitoring
Track patient enrollment and recommend solutions to improve enrollment of qualified subjects
Support processing of data queries, deviations, and adverse events
Write monitoring visit reports
Develop and execute site close-out plans and activities
Ensure adherence to ICH-GCP, SOPs, IRB regulations, study protocols, FDA regulations, and ICH guidelines
Coordinate data management activities
Generate protocol and informed consent drafts for management review
Create literature reviews for new study indications
Assist with CRF development and investigator meetings
Create study status data tables and slide decks for upper management review
Create and maintain study site investigator binders
Maintain working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, relevant regulations, and organizational policies
Start responsibilities punctually, maintain consistent presence throughout shifts, and attend scheduled meetings
Perform other duties as assigned

Requirements

What you’ll need

Bachelor's degree required, preferably in Clinical Research, Life Sciences or a related field
CRA certification such as CCRA or CCRP strongly preferred
3 years of relevant experience in industry or experience working with Sponsor companies as a clinic coordinator required
Prior study supervision experience required
Favorable background investigation required
Valid Class “C” driver's license
In-depth understanding of ICH-GCP, FDA regulations, and clinical research methodology
Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Strong organizational and problem-solving abilities with attention to detail
Effective verbal and written communication skills
Ability to work independently and collaboratively in a fast-paced environment
Ability to manage travel and multiple site relationships simultaneously
Flexibility to work outside normal business hours on weekdays or weekends with reasonable advance notice

Benefits

Comp & perks

Remote work
Full-time employment
Up to 50% travel required for the role