Clinical Research Associate

Hello humankindness Located conveniently in the heart of Phoenix, Arizona,St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s. U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies.

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Join BNI CRO as a Clinical Research Associate (CRA) and collaborate with dedicated research sites contributing to rare neurological disease research. Make a significant impact in the scientific community alongside a dedicated team of CRAs. This remote position involves up to 75% travel across the US primarily focusing on regional site assignments. Your role will encompass important site monitoring and management activities including SIVs Interim and Remote Monitoring Visits as well as Final Onsite and Closeout Visits. Advance your career and acquire valuable skills at Barrow Neurological Institute all while contributing to groundbreaking clinical research! Experienced and entry level positions available!

To be successful in this role, you will bring relevant clinical research experience and a strong understanding of regulatory guidelines. Your exceptional organizational skills, attention to detail, and ability to communicate effectively will be crucial in this dynamic field.

• Responsible for all aspects of clinical monitoring, site management, and trial administration as prescribed in the monitoring plan and as instructed by program leadership. Employee is responsible for working with sites during study start up, including assessing site feasibility as required, provide ongoing training and site initiation visits, conducting remote monitoring, and approx. 25-30 interim onsite and closeout field monitoring visits located throughout the US and Canada. During each monitoring visit the CRA is responsible for the evaluation of clinical data documentation, regulatory document review, monitor safety and conduct of study to ensure investigator and site compliance with study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPAA guidelines. The CRA is expected to work cooperatively with study team and operations management to proactively drive project success.
• Completes preparation and submission of accurate and timely monitoring reports, and other requested deliverables, as outlined in the Study Monitoring Plan or as requested by program leadership.
• Effective long-term planning/scheduling of 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 BNI CRO provides quality monitoring and site management customer services. The Lead Study Monitor will be responsible for the timely review of all monitoring deliverables, conduct co-monitoring visits and mentorship of CRA team members.
• Participates in the quality control process for assigned monitoring activities, and makes contributions to improve and adapt quality control procedures, including the development of internal corrective and preventative action plans if needed, and align service goals with internal and external client expectations
• Proactively participate in program development. This includes making contributions to the overall quality improvement of clinical monitoring services, as well as actively collaborating with program leadership to expand and grow the CRO's professional portfolio.

Required

• Bachelors Other or equivalent combination of education and experience or its international equivalent in clinical, science, or health related field from an accredited institution
• 2-3 years of clinical research experience required or a combination of equivalent experience and education
• Experience with Microsoft Office Suite Systems

Preferred

• Registered Nurse: AZ, or
• Physical Therapist: AZ, or
• Occupational Therapist: AZ, or
• Clinical Research Associate, or
• Certified Clinical Research Professional