Senior Clinical Research Associate

Dayforce

Senior Clinical Research Associate supporting clinical operations in clinical trials for medical devices. Responsible for compliance, monitoring, and reporting across various clinical studies.

Posted 7/28/2026full-timeRemote • North Carolina • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical research management, ensuring compliance with Good Clinical Practices (GCPs), FDA regulations, and IRB requirements. Proficient in project management, data integrity, and effective communication across cross-functional teams.

Highest-signal resume keywords

Clinical Research ManagementGood Clinical Practices (GCPs)Project ManagementElectronic Data Capture (EDC)Trial Master File (TMF) Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Protocol ComplianceSite Qualification VisitsSource Data VerificationAdverse Event ReviewData Quality AssuranceMedical Device TrialsRegulatory ReportingDocument ManagementData Trending AnalysisSOP Maintenance

Soft Skills

Verbal CommunicationWritten CommunicationAttention to DetailProfessionalismTeam Collaboration

Tools & Technologies

Microsoft Office SuiteElectronic Trial Master File (eTMF)Clinical Monitoring Plan

Industry Keywords

Institutional Review Board (IRB)Code of Federal Regulations (CFR)Clinical ResearchInvestigational DeviceHuman Subject Protection

About the role

Key responsibilities & impact

Responsible for ensuring that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions
Acts as primary liaison to clinical sites.
Conducts site qualification visits, study start-up activities (essential document collection), site qualification visits, site initiation visits and training, monitoring visits for source data verification (reported study data are accurate, complete, and verifiable from source documents in the site’s medical records), and site close-out visits. Generates high-quality site qualification, initiation, monitoring, and close-out visit reports in timely manner (in accordance with the Clinical Monitoring Plan)
Contributes to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities
Ensures that the rights and well-being of human subjects are protected and confirms data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
Supports maintenance of department SOPs and work instructions
Supports investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
Supports and maintains documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.
Drives trial enrollment and identifies and communications potential and actual obstacles to enrollment.

Requirements

What you’ll need

Minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials.
Must be able to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines. May work on highly visible projects in high-pressure situations
Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements.
Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail.
Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with clients/partners.
Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint; as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
Familiarity with medical and anatomical terminology.
Ability and willingness to travel

Benefits

Comp & perks

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Responsible for ensuring that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions
Acts as primary liaison to clinical sites.
Conducts site qualification visits, study start-up activities (essential document collection), site qualification visits, site initiation visits and training, monitoring visits for source data verification (reported study data are accurate, complete, and verifiable from source documents in the site’s medical records), and site close-out visits. Generates high-quality site qualification, initiation, monitoring, and close-out visit reports in timely manner (in accordance with the Clinical Monitoring Plan)
Contributes to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities
Ensures that the rights and well-being of human subjects are protected and confirms data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
Supports maintenance of department SOPs and work instructions
Supports investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
Supports and maintains documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.
Drives trial enrollment and identifies and communications potential and actual obstacles to enrollment. 🎯 Requirements
Minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials.
Must be able to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines. May work on highly visible projects in high-pressure situations
Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements.
Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail.
Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with clients/partners.
Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint; as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
Familiarity with medical and anatomical terminology.
Ability and willingness to travel Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Senior Clinical Research Associate 🔥 38 minutes ago ERGOMED 1001 - 5000 💼 Consulting 🏥 Healthcare 📦 Logistics Website LinkedIn All Job Openings Senior Clinical Research Associate responsible for performing monitoring visits for clinical trials. Ensuring adequate facilities and training site staff throughout the study period. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🔬 Research Analyst Senior Clinical Research Associate 🔥 39 minutes ago PSI CRO AG 1001 - 5000 🏥 Healthcare 💼 Consulting 📦 Logistics Website LinkedIn All Job Openings Senior Clinical Research Associate at PSI responsible for managing clinical trial compliance and project timelines. Involvement in site communication and oversight of monitoring activities. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🔬 Research Analyst Senior Clinical Research Associate 🔥 1 hour ago CTI Clinical Trial and Consulting Services 1001 - 5000 💼 Consulting 🏥 Healthcare 🧬 Biotechnology Website LinkedIn All Job Openings Senior Clinical Research Associate conducting monitoring for clinical studies and managing project activities. Ensuring adherence to regulatory guidelines and contributing to the study start-up process. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🔬 Research Analyst Patient Collections Research Specialist 🔥 2 hours ago Sarnova 1001 - 5000 🏥 Healthcare 🤝 B2B ☁️ SaaS Website LinkedIn All Job Openings Patient Collections Research Specialist responsible for gathering patient information for EMS claims. Collaborating with internal teams and external partners to ensure accurate and timely claim resolution. 🇺🇸 United States – Remote 💰 $500k Venture Round - Sarnova on 2009-12 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🔬 Research Analyst Senior Research & Development Tax Credit Specialist 🔥 2 hours ago KBKG Transfer Pricing 51 - 200 💼 Consulting 🤝 B2B 💸 Finance Website LinkedIn All Job Openings R&D Tax Credit Senior Specialist in San Jose conducting tax research and overseeing Specialists. Engaging in client relationships and managing projects from start to finish. 🇺🇸 United States – Remote 💵 $80k - $105k / year ⏰ Full Time 🟠 Senior 🔬 Research Analyst View More Research Analyst Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs