Clinical Research Associate

About the Role

As a Clinical Research Professional at Barrow Neurological Institute (BNI), you will be instrumental in advancing medical knowledge by expertly managing and executing clinical trials. You will ensure the highest standards of data integrity, patient safety, and regulatory compliance throughout the research process. This role involves managing trial activities, including participant recruitment, data collection, and documentation, while serving as a key liaison for all stakeholders. You will ensure strict adherence to protocols and regulatory requirements from study initiation to completion.

At BNI, one of the world’s premier neuroscience centers, you will join a nationally recognized team coordinating NIH/NINDS-funded studies that are changing how amyotrophic lateral sclerosis (ALS) is diagnosed, monitored, and ultimately treated. This position offers the opportunity to work alongside dedicated research sites while ensuring the highest standards of participant safety, regulatory compliance, and data quality.

Responsibilities

• Manage all aspects of clinical monitoring, site management, and trial administration as prescribed in the monitoring plan and as instructed by program leadership.
• Work with sites during study start-up, including assessing site feasibility, providing ongoing training, and conducting site initiation visits.
• Conduct remote monitoring and approximately 25-30 interim onsite and closeout field monitoring visits throughout the US and Canada.
• Evaluate clinical data documentation, review regulatory documents, monitor safety, and ensure investigator and site compliance with study protocol, FDA regulations, ICH/GCP guidelines, institutional/CRO SOPs, and HIPAA guidelines.
• Work cooperatively with the study team and operations management to proactively drive project success.
• Prepare and submit accurate and timely monitoring reports and other requested deliverables as outlined in the Study Monitoring Plan.
• Plan and schedule remote and on-site monitoring visits in accordance with the Study Monitoring Plan or as requested by program leadership.
• Perform Lead Study Monitoring activities as assigned, including acting as the primary liaison between BNI CRO and the Clinical Study Sponsor to ensure quality monitoring and site management customer services.
• Review all monitoring deliverables, conduct co-monitoring visits, and mentor CRA team members as the Lead Study Monitor.
• Participate in the quality control process for assigned monitoring activities and contribute to improving and adapting quality control procedures, including developing internal corrective and preventative action plans if needed.
• Proactively participate in program development, contributing to the overall quality improvement of clinical monitoring services and collaborating with program leadership to expand and grow the CRO's professional portfolio.

Requirements

• Bachelor’s degree or its international equivalent in clinical, science, or health-related field from an accredited institution, or five (5) years of equivalent work experience in lieu of the degree.
• Two (2)+ years of clinical research experience.
• Experience with Microsoft Office Suite Systems.

Preferred Qualifications

• Registered Nurse (AZ license), Physical Therapist (AZ license), Occupational Therapist (AZ license), or Certified Clinical Research Professional.

About the Workplace

Join Saint Joseph’s Hospital and Medical Center (SJHMC) in Phoenix, AZ, a 571-bed nonprofit founded by the Sisters of Mercy over 125 years ago. SJHMC is a global destination for life-changing care, embracing patients with humankindness. As part of this mission-driven community, you will work at the forefront of medical innovation.

• Barrow Neurological Institute (BNI): A world-renowned center for groundbreaking neurological research and innovative treatments.
• Norton Thoracic Institute (NTI): A national leader in advanced thoracic care with pioneering surgical techniques.
• Level I Trauma Center: One of Arizona's busiest ERs, providing immediate, comprehensive care for critically injured patients 24/7.

SJHMC fosters a culture of excellence and well-being, offering professional and personal growth opportunities within a collaborative community dedicated to global health.

Pay

$35.62 - $52.99 per hour.