Senior Clinical Research Associate – Ops Lead

BD; United States; Remote; USD 96,000 - 153,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Dental/medical coverage

Job summary

Waters is seeking a Senior Clinical Research Associate to manage site monitoring across multiple studies, ensuring GCP compliance and regulatory alignment. The role serves as a key resource to the study teams and mentors junior CRAs.

The Sr. CRA will demonstrate strong communication, organizational, and time-management skills, with experience using Veeva Vault CTMS and CDMS for data integrity and trial execution.

Qualifications

• Bachelor’s degree or higher in a healthcare or science-related field.
• 3 years of field-based CRA experience in medical device/pharma.
• Strong understanding of clinical trial operations and data management.
• Thorough knowledge of ICH GCP, FDA CFR, ISO, and HIPAA.

Responsibilities

• Serve as CRA for assigned complex studies, including site initiation, monitoring, and close-out.
• Participate in site feasibility and site selection processes.
• Ensure conduct adheres to protocol, regulatory requirements, and SOPs.
• Prioritize patient safety and ethical conduct; oversee informed consent.
• Review AEs/SAEs and protocol deviations per regulatory requirements.
• Maintain regulatory docs and TMFs in ALCOA-compliant manner.
• Monitor site inventory of investigational products and study supplies.
• Identify and manage study risks to ensure continuity and compliance.
• Author and review Monitoring Plans and site training materials.
• Perform SDR/SDV and document monitoring through trip reports.

Skills

Clinical trial operations

GCP compliance

Regulatory knowledge

Veeva Vault CTMS

CDMS

Education

Bachelor’s degree or higher in healthcare or science

Tools

Veeva Vault CTMS

CDMS

Job description

Waters is seeking a Senior Clinical Research Associate to manage site monitoring across multiple studies, ensuring GCP compliance and regulatory alignment. The role serves as a key resource to the study teams and mentors junior CRAs.

The Sr. CRA will demonstrate strong communication, organizational, and time-management skills, with experience using Veeva Vault CTMS and CDMS for data integrity and trial execution.