Clinical Research Associate

Becton Dickinson; United States; Hybrid; USD 70,000 - 110,000; Full time

Job summary

Waters is seeking a Clinical Research Associate to manage and monitor assigned clinical studies, ensuring compliance with GCP and regulatory standards in a global environment.

The role offers exposure to site management, SDR/SDV activities, and collaboration with cross‑functional teams, with about 40% travel and a remote or hybrid work setup.

Qualifications

• Bachelor's degree or higher in healthcare, life sciences, or 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.

Responsibilities

• Manage and monitor assigned clinical sites and studies to ensure compliance, quality, and operational success.
• Conduct monitoring activities, including qualification, initiation, routine monitoring, and closeout visits through onsite, remote, virtual, or in‑house methods.
• Perform source data review (SDR) and source data verification (SDV) according to study requirements.
• Develop a comprehensive understanding of study protocols, investigational products, instructions for use (IFU), and related study documentation.
• Review and contribute to monitoring plans, study source documents, and other study‑related materials.
• Ensure sites conduct clinical studies in compliance with protocol requirements, GCP, ISO standards, regulatory requirements, and IRB/EC policies.
• Prioritize patient safety and verify proper informed consent procedures are followed 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 regarding site status, performance, risks, and progress.
• Maintain Trial Master Files (TMF) and ensure timely site closeout activities.

Skills

Clinical Research

GCP compliance

Site management

Regulatory knowledge

Communication

Education

Bachelor's degree (healthcare, life sciences, or related)

Tools

EDC

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Summary:

The Clinical Research Associate (CRA) is responsible for the management and monitoring of assigned clinical research studies and investigative sites. This role ensures studies are conducted in compliance with Good Clinical Practice (GCP), applicable regulatory requirements, company policies, and established quality standards.The CRA will collaborate closely with cross-functional teams and study sites to support the successful execution of clinical research activities. This position offers an excellent opportunity for early-career clinical research professionals to develop monitoring expertise through hands‑on site management, study oversight, and collaboration with experienced clinical operations leaders. This role requires approximately 40% travel.The CRA will have strong organizational, communication, and site management skills and the ability to manage multiple priorities and meet competing deadlines in a fast‑paced environment. They will work independently while fostering teamwork in a remote or hybrid environment.

Responsibilities

• Manage and monitor assigned clinical sites and studies to ensure compliance, quality, and operational success.
• Conduct monitoring activities, including qualification, initiation, routine monitoring, and closeout visits through onsite, remote, virtual, or in‑house methods.
• Perform source data review (SDR) and source data verification (SDV) according to study requirements.
• Develop a comprehensive understanding of study protocols, investigational products, instructions for use (IFU), and related study documentation.
• Review and contribute to monitoring plans, study source documents, and other study‑related materials.
• Ensure sites conduct clinical studies in compliance with protocol requirements, GCP, ISO standards, regulatory requirements, and IRB/EC policies.
• Prioritize patient safety and verify proper informed consent procedures are followed 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 regarding 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 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

• 2 years of Clinical Research Associate experience, Clinical Research Coordinator experience, or relevant laboratory experience supporting 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 working with electronic data capture (EDC), clinical trial manage