Clinical Research Associate

Extremity Care

. Oversee operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to GCP guidelines .

Posted 10/16/2026full-timeRemote • Texas • United StatesMid-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 multiple trial sites effectively. Proficient in developing monitoring plans, evaluating site performance, and maintaining data integrity throughout the clinical research process.

Highest-signal resume keywords

ICH-GCP ComplianceClinical Trial ManagementCRA CertificationData Integrity OversightSite Performance Evaluation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research MethodologyMonitoring Plan DevelopmentData Query ProcessingCRF DevelopmentProtocol DraftingMetrics DevelopmentSite Activation ProcessesPatient Enrollment TrackingAdverse Event ManagementStudy Close-Out Activities

Soft Skills

Strong Organizational AbilitiesProblem-Solving SkillsEffective Communication SkillsAbility to Work IndependentlyCollaborative Teamwork

Tools & Technologies

Microsoft OfficeData Management SystemsStudy Status Data TablesSlide Deck Creation

Certifications & Qualifications

CRA CertificationCCRACCRP

Industry Keywords

FDA RegulationsICH GuidelinesSOPsIRB RegulationsAATB StandardsISO StandardsCGMP/CGTPClinical Trial ConductInvestigational SitesSite Qualification

About the role

Key responsibilities & impact

Oversee operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to GCP guidelines
Evaluate clinical trial resourcing requirements for site qualification, initiation, monitoring, and site support
Work with multiple trial sites and studies across varying indications simultaneously
Develop and maintain monitoring plans for assigned clinical trials
Liaise with clinic and hospital investigators and staff throughout study conduct
Oversee trial site setup and ensure sites have appropriate trial materials
Oversee site activation processes
Develop and monitor metrics for monitor and site performance; evaluate causes and mitigate study risk
Review data to identify issues or inconsistencies in collection or monitoring
Track patient enrollment and recommend solutions to increase appropriate enrollment
Support processing of data queries, deviations, adverse events, and related items
Write monitoring visit reports
Develop and execute trial 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 from study start to end
Perform other duties as assigned

Requirements

What you’ll need

Bachelor's degree required, preferably in Clinical Research, Life Sciences or a related field
3 years of relevant experience in industry or has worked with Sponsor companies as a clinic coordinator required
Prior study supervision experience required
Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred
Clearance of favorable background investigation required
Valid Class “C” drivers license
In-depth understanding of ICH-GCP, FDA regulations, and clinical research methodology
Strong organizational and problem-solving abilities with an eye for detail
Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Effective verbal and written communication skills
Ability to work both independently and collaboratively in a fast-paced environment
Capacity to manage travel and multiple site relationships simultaneously
Working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, relevant regulations/standards, and internal organizational policies and SOPs
Ability to start job responsibilities punctually, maintain consistent presence throughout the entire shift, and attend scheduled meetings and appointments
Flexibility to work outside normal business hours on weekdays or weekends with reasonable advance notice
Must be able to manage travel and multiple site relationships simultaneously

Benefits

Comp & perks

Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary