Clinical Research Associate

CommonSpirit Health•Phoenix, AZ

3d•Remote

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.