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BD

Principal Clinical Research Associate

BD

Lead CRA overseeing complex clinical studies at Waters Corporation, ensuring compliance and prioritizing patient safety through expert management and training.

Posted 7/2/2026full-timeRemote • Maryland • 🇺🇸 United StatesJuniorMid-Level💰 $117,800 - $188,600 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud PlatformVault

About the role

Key responsibilities & impact
  • Serve as Lead CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and close‑out activities (on‑site, virtual, remote, and in‑house)
  • Actively participate in site feasibility assessments and site selection processes
  • Ensure study conduct is executed according to the clinical protocol (CPSP), regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs
  • Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically
  • Review and report AEs/SAEs and protocol deviations in accordance with regulatory and company requirements
  • Maintain complete, accurate, and audit‑ready regulatory documentation and TMFs in accordance with ALCOA principles
  • Monitor site inventory of investigational products and study supplies
  • Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance
  • Author, review, and approve Monitoring Plans, study source documents, monitoring tools, and site‑facing training materials
  • Perform SDR/SDV per monitoring plans and document monitoring activities through timely, high‑quality trip reports
  • Ensure strict compliance with company travel and expense policies
  • Provide mentoring, training, and functional oversight of CRAs, including contingent (contract) CRAs
  • Lead or review functional job aids and training materials
  • Support interviewing, hiring, onboarding, and training of CRA staff
  • Manage and oversee day‑to‑day activities of contingent CRAs, including approval of timecards and expense reports
  • Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues
  • Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS
  • Work cross‑functionally with internal teams, CROs, and SMOs to ensure high‑quality study execution and oversight
  • Build and maintain effective working relationships with investigator sites and internal stakeholders

Requirements

What you’ll need
  • Bachelor’s degree or higher in a healthcare or science-related field
  • Minimum of five (5) years of field-based CRA experience in the medical device and/or pharmaceutical industry
  • Experience across multiple phases of clinical research and product development
  • Experience with IVD and/or POC studies strongly preferred
  • Laboratory experience in molecular biology, microbiology, or blood culture is highly desirable
  • Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management
  • Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA
  • Proficiency with Veeva Vault CTMS and CDMS required
  • Excellent written and verbal English communication skills, including medical terminology
  • Strong presentation, organizational, time-management, and prioritization skills
  • Technically savvy with the ability to leverage technology to drive efficiency and performance
  • Ability to work independently with minimal supervision in a fast-paced environment

Benefits

Comp & perks
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities

ATS Keywords

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Hard Skills & Tools
Clinical Protocol ExecutionSite Feasibility AssessmentAdverse Event ReportingRegulatory Documentation ManagementInvestigational Product ManagementData ManagementMonitoring Plan DevelopmentSDR/SDV ExecutionAudit-Ready DocumentationLaboratory Experience in Molecular Biology
Soft Skills
Excellent Written and Verbal CommunicationStrong Presentation SkillsOrganizational SkillsTime ManagementPrioritization Skills