Senior Clinical Research Associate — Global Trial Leadership

BD; Alabama; On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health & well-being: medical/dental/视

401(k)

Job summary

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

You will ensure high-quality study execution, maintain regulatory compliance, and guide junior CRAs while supporting investigators and sites in fast-paced environments. The role requires strong communication, organizational, and time-management skills, with proficiency in Veeva Vault CTMS/CDMS and collaboration across internal teams and CROs.

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, overseeing 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 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, 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.
• Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS.
• Work cross-functionally with internal teams and CROs to ensure high-quality study execution and oversight.
• Build and maintain effective working relationships with investigator sites and internal stakeholders.

Skills

Clinical trial operations

Regulatory knowledge

Data management

Investigational product management

Education

Bachelor's degree or higher in healthcare/science

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 clinical studies.

You will ensure high-quality study execution, maintain regulatory compliance, and guide junior CRAs while supporting investigators and sites in fast-paced environments. The role requires strong communication, organizational, and time-management skills, with proficiency in Veeva Vault CTMS/CDMS and collaboration across internal teams and CROs.