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Clinical Research Associate
ICON plc. Monitor progress of clinical studies at the site level to verify subject rights and well-being, data accuracy and completeness, and compliance with protocol, SOPs, ISO/GCP, and applicable regulations .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in monitoring clinical studies, ensuring compliance with protocols and regulations, and maintaining data integrity. Proficient in training site personnel and collaborating with cross-functional teams throughout all study phases.
Highest-signal resume keywords
Clinical Study MonitoringMedical Device ExperienceRegulatory ComplianceMS Office ProficiencySite Training and Support
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data Accuracy VerificationProtocol ComplianceSource Document ReviewCase Report Form ComparisonEvent Reporting
Soft Skills
Effective CommunicationProblem SolvingCollaboration
Tools & Technologies
Medidata RAVEVEEVA Vault
Certifications & Qualifications
Bachelor's DegreeRegistered Nurse (RN)
Industry Keywords
ISOGCPInterventional CardiologyCardiac Rhythm ManagementCardiac ElectrophysiologyNeuromodulationUrologyEndoscopy
Tech Stack
Tools & technologiesGoogle Cloud PlatformVault
About the role
Key responsibilities & impact- Monitor progress of clinical studies at the site level to verify subject rights and well-being, data accuracy and completeness, and compliance with protocol, SOPs, ISO/GCP, and applicable regulations
- Provide on-site and remote support during clinical trial start-up, enrollment, follow-up, and closure
- Review subject source documents and ensure protocol requirements are met and reported
- Compare Case Report Form data against source documents and verify informed consent forms
- Review regulatory documents and device accountability records; investigate and resolve data discrepancies
- Communicate with clinical sites and project team members through monitoring reports, follow-up letters, study memos, and correspondence
- Train site personnel and maintain site personnel, qualification, and training records
- Address, document, and escalate site non-compliance issues; support regulatory inspection activities
- Identify, document, and report reportable events
- Participate in study-specific meetings, teleconferences, and trainings
- Collaborate with cross-functional team members and study sites throughout all study phases
- Work with the In-house CRA team to collect and review investigator/site documentation and approve applicable database documents
Requirements
What you’ll need- Minimum of 1 year of medical device experience
- Minimum of 2 years of site monitoring experience
- Bachelor's degree or Registered Nurse (RN) qualification
- Ability to travel up to 60%
- Therapeutic experience aligned with at least one Boston Scientific division: Interventional Cardiology, Cardiac Rhythm Management, Cardiac Electrophysiology, Neuromodulation, Urology, or Endoscopy
- Proficient with MS Office skills (Word, Excel, PowerPoint, Teams)
- Prior experience with Medidata RAVE and VEEVA Vault preferred
- The candidate should be based in or near Philadelphia, Boston, or Dallas
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways