Senior Clinical Research Associate — Global Trial Operations

BD; California (MO); On-site; USD 100,000 - 140,000; Full time

Job summary

Waters is seeking a Senior Clinical Research Associate (Sr. CRA) to manage site monitoring and relationships across multiple studies in a regulated environment.

You will ensure GCP and regulatory compliance, support study teams, and guide less experienced CRAs while working with internal and CRO partners. The candidate will demonstrate excellent communication, organizational, and time management, with the ability to work independently in a fast-paced setting and contribute to study objectives

Qualifications

• Bachelor’s degree or higher in a healthcare or science‑related field (or equivalent experience)
• 3 years of field‑based CRA experience in medical device/pharma industry
• Strong understanding of clinical trial operations and monitoring practices
• Thorough knowledge of ICH GCP, FDA CFR, ISO, and HIPAA

Responsibilities

• Manage site monitoring across complex studies (on-site, virtual, remote)
• Lead site feasibility assessments and site selection
• Ensure study conduct complies with protocol, regulatory standards, IRB/EC and SOPs
• Prioritize patient safety and proper informed consent procedures
• Review and report AEs/SAEs and protocol deviations
• Maintain regulatory documentation and TMFs in ALCOA-compliant manner
• Monitor inventory of investigational products and study supplies
• Identify and manage study risks to ensure continuity and compliance
• Author/approve Monitoring Plans and training materials
• Perform SDR/SDV per monitoring plans and document actions
• Ensure adherence to travel and expense policies
• Provide mentoring and oversight of CRAs
• Lead or review training materials and job aids
• Present updates on site status, risks and issues
• Use Veeva Vault CTMS and CDMS for data management
• Collaborate with internal teams and CROs
• Build relationships with investigator sites and stakeholders

Skills

Clinical trial operations

Monitoring practices

Data management

Regulatory knowledge

Education

Bachelor’s degree or higher

Tools

Veeva Vault CTMS

CDMS

Job description

Waters is seeking a Senior Clinical Research Associate (Sr. CRA) to manage site monitoring and relationships across multiple studies in a regulated environment.

You will ensure GCP and regulatory compliance, support study teams, and guide less experienced CRAs while working with internal and CRO partners. The candidate will demonstrate excellent communication, organizational, and time management, with the ability to work independently in a fast-paced setting and contribute to study objectives