Clinical Research Associate

About the role

This Clinical Research Associate (CRA) role sits within Waters’ integrated global life-sciences organization, formed by the combination of BD Biosciences and Diagnostic Solutions with Waters Corporation. The position offers early-career professionals the chance to develop hands-on monitoring expertise while supporting regulated, high-volume clinical studies that accelerate the release of safe, effective medicines, assure food and water safety, and improve patient outcomes.

Responsibilities

• Manage and monitor assigned investigative sites and clinical studies to ensure compliance, quality, and operational success.
• Conduct all monitoring activities—qualification, initiation, routine monitoring, and closeout—via onsite, remote, virtual, or in-house methods as required.
• Perform source data review (SDR) and source data verification (SDV) in accordance with study-specific requirements.
• Develop a thorough understanding of study protocols, investigational products, instructions for use (IFU), and related documentation.
• Review and contribute to monitoring plans, study source documents, and other study-related materials.
• Ensure sites adhere to protocol requirements, Good Clinical Practice (GCP), ISO standards, regulatory requirements, and IRB/EC policies.
• Prioritize patient safety and verify that informed consent procedures are properly executed and documented.
• Support site feasibility assessments and site selection activities.
• Prepare timely, accurate, and high-quality monitoring reports, visit documentation, and communication records.
• Facilitate site initiation visits and support the development and delivery of site-facing training and presentation materials.
• Identify, communicate, and help resolve study risks, issues, and compliance concerns.
• Participate in study team meetings and provide regular updates on site status, performance, risks, and progress.
• Maintain Trial Master Files (TMF) and ensure timely site closeout activities.

Required Qualifications

• Bachelor’s degree or higher in healthcare, life sciences, or a related scientific discipline.
• Working knowledge of clinical trial processes, monitoring activities, data management, and investigational product handling.
• Knowledge of applicable regulations and guidelines, including ICH-GCP, FDA regulations, ISO standards, and HIPAA requirements.

Preferred Qualifications & Skills

• Up to 2 years of experience as a Clinical Research Associate, Clinical Research Coordinator, or relevant laboratory support role in clinical research, diagnostics, biotechnology, medical device, or pharmaceutical studies.
• Experience supporting diagnostic, in vitro diagnostic (IVD), point-of-care (POC), molecular biology, microbiology, or laboratory-based clinical studies.
• Laboratory experience in molecular biology, microbiology, or blood culture testing.
• Experience with electronic data capture (EDC), clinical trial management systems (CTMS), and electronic Trial Master File (eTMF) platforms.
• Familiarity with Veeva Vault TMF and/or Veeva CDMS platforms.

What Makes You Successful

• Strong attention to detail and commitment to quality.
• Ability to build relationships with investigative sites and internal stakeholders.
• Excellent organizational and time-management skills.
• Strong written and verbal communication skills.
• Adaptability and willingness to learn in a fast-paced clinical research environment.