Senior Clinical Research Associate - Remote/Hybrid

BD; Delaware; On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Job summary

Waters is seeking a Senior Clinical Research Associate to lead site monitoring and study management across multiple clinical trials in a fast-paced, regulated environment. The role requires ensuring GCP compliance, regulatory adherence, and high-quality data capture while mentoring junior CRAs.

The ideal candidate will bring hands-on CRA experience, expertise with Veeva Vault CTMS and CDMS, and a proven ability to build strong relationships with sites and cross-functional teams.

Qualifications

• Bachelor's degree or higher in a healthcare or science-related field.
• 3 years of field-based CRA experience in the medical device and/or pharmaceutical industry.
• 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.

Responsibilities

• Serve as CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and close‑out activities (on-site, virtual, remote).
• Actively participate in site feasibility assessments and site selection processes.
• Ensure study conduct is executed according to the clinical protocol, 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 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.
• Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues.

Skills

Clinical trials

GCP knowledge

Education

Bachelor's degree or higher in healthcare/science

Tools

Veeva Vault CTMS

CDMS

Job description

Waters is seeking a Senior Clinical Research Associate to lead site monitoring and study management across multiple clinical trials in a fast-paced, regulated environment. The role requires ensuring GCP compliance, regulatory adherence, and high-quality data capture while mentoring junior CRAs.

The ideal candidate will bring hands-on CRA experience, expertise with Veeva Vault CTMS and CDMS, and a proven ability to build strong relationships with sites and cross-functional teams.