Senior CRA: Global Clinical Operations Leader

BD; Arizona; Vor Ort; USD 85.000 - 125.000; Vollzeit

Benefits dieser Stelle

Health & Well-being

401(k)

Zusammenfassung

Waters is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee site monitoring and relationships across multiple clinical studies, ensuring GCP compliance and high-quality execution. The role includes mentoring junior CRAs, supporting investigators, and proactively addressing operational risks.

The Sr. CRA will leverage strong communication and organizational skills, with experience in regulatory frameworks and study management.

Qualifikationen

• 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.
• Alternate education levels may be considered based on experience and business need

Aufgaben

• Manage site monitoring and relationship activities across multiple studies (on-site, virtual, remote).
• Participate in site feasibility assessments and site selection processes.
• Ensure study conduct adheres to protocol, regulatory requirements, IRB/EC, and SOPs.
• Prioritize patient safety and informed consent.
• Review and report AEs/SAEs and protocol deviations.
• Maintain regulatory documentation and TMFs (ALCOA).
• Monitor site inventory of investigational products.
• Identify and manage study risks and issues.
• Author/approve Monitoring Plans and site training materials.
• Perform SDR/SDV and document monitoring through trip reports.
• Ensure compliance with travel and expense policies.
• Mentor and oversee CRAs (including contractors).
• Lead or review training materials and process improvements.
• Present updates on site status and risks in cross-functional meetings.
• Maintain data in CTMS/CDMS and collaborate with internal teams.

Kenntnisse

Field-based CRA experience

Clinical trial operations

Regulatory knowledge (GCP, FDA CFR,ISO

Communication

Mentoring/leadership

Ausbildung

Bachelor's degree or higher in healthcare/science

Tools

Veeva Vault CTMS

CDMS

Jobbeschreibung

Waters is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee site monitoring and relationships across multiple clinical studies, ensuring GCP compliance and high-quality execution. The role includes mentoring junior CRAs, supporting investigators, and proactively addressing operational risks.

The Sr. CRA will leverage strong communication and organizational skills, with experience in regulatory frameworks and study management.