Senior Clinical Research Associate

ClinChoice

. Serve as the primary sponsor/CRO contact for assigned sites and maintain regular communication with investigators and study coordinators .

Posted 11/4/2026contractRemote • Florida • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research monitoring, including site performance tracking, regulatory compliance, and data management. Proficient in conducting monitoring visits, ensuring informed consent, and supporting audit preparations.

Highest-signal resume keywords

Clinical Research Associate (CRA) ExperienceICH E6 Good Clinical Practice KnowledgeEDC, CTMS, and eTMF Systems ProficiencyFDA Regulations ComplianceClinical Research Certification (ACRP-CP, CCRA, SOCRA CCRP)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site Performance TrackingSource Data VerificationRegulatory Documentation ReviewProtocol Deviation IdentificationData Cleaning and Query ResolutionInvestigational Product AccountabilityAdverse Event ReportingRisk-Based MonitoringDatabase Lock PreparationSite Closeout Activities

Soft Skills

Effective CommunicationProblem-SolvingTeam CollaborationTraining and MentoringAttention to Detail

Tools & Technologies

Electronic Data Capture (EDC)Clinical Trial Management System (CTMS)Electronic Trial Master File (eTMF)

Certifications & Qualifications

ACRP-CPCCRASOCRA CCRP

Industry Keywords

Good Clinical PracticeFDA InspectionsMedical Device TrialsSleep Medicine StudiesRespiratory TrialsCardiometabolic TrialsOSA StudiesInformed Consent ComplianceCAPA ManagementIRB Review Tracking

About the role

Key responsibilities & impact

Serve as the primary sponsor/CRO contact for assigned sites and maintain regular communication with investigators and study coordinators
Track site performance, follow-up visit schedules, data entry timelines, and query resolution; escalate risks
Support site staff turnover through retraining and delegation log updates
Ensure adequate site resources, equipment calibration, and investigational product or device storage
Conduct on-site, remote, and risk-based monitoring visits and complete visit documentation
Perform source data verification and review of follow-up data, sleep study results, questionnaires, and device adherence data
Verify informed consent compliance and re-consent after protocol or ICF amendments
Review adverse events, serious adverse events, and device deficiencies for accurate regulatory reporting
Identify and follow up on protocol deviations and CAPAs
Oversee investigational product/device accountability, reconciliation, return, or destruction
Support subject retention, missed-visit reduction, withdrawal tracking, and long-term/end-of-study follow-up
Resolve EDC data queries and support data cleaning, interim/final data reviews, and database lock preparation
Ensure ISF completeness and reconciliation with the TMF
Track IRB reviews, amendment approvals, safety reports, and regulatory documentation
Prepare sites for sponsor audits and FDA inspections and support responses to findings
Plan and conduct site closeout visits and post-study reconciliation, reporting, and regulatory activities
Contribute to lessons learned and study-team process improvements

Requirements

What you’ll need

Bachelor's degree in life sciences, nursing, pharmacy, or a related health field (or equivalent experience)
2+ years of independent on-site monitoring experience as a CRA with a sponsor, CRO, or medical device company
Working knowledge of ICH E6 Good Clinical Practice, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312 and/or 812), and HIPAA
Experience monitoring studies through follow-up, database lock, and site closeout
Hands-on experience with EDC, CTMS, and eTMF systems
Valid driver's license and ability to travel to assigned sites
Authorization to work in the United States
Preferred: experience in sleep medicine, respiratory, cardiometabolic, or ENT trials, including OSA studies
Preferred: familiarity with PSG, HSAT, and CPAP or implantable/oral device studies
Preferred: medical device trial experience, including IDE studies, device accountability, and device deficiency reporting
Preferred: experience supporting FDA inspections or sponsor audits
Preferred: clinical research certification such as ACRP-CP, CCRA, or SOCRA CCRP

Benefits

Comp & perks

Professional development and continuous training
Supportive culture and close management
Equal opportunity, diversity, and inclusivity
Global CRO career opportunities and job security
Sponsor-dedicated work arrangement
Home-based/remote work arrangement