At Barrow Neurological Institute (BNI), one of the world’s premier neuroscience centers, we are leading groundbreaking multicenter clinical research to accelerate discoveries for people living with amyotrophic lateral sclerosis (ALS). As part of our Academic Clinical Research Organization (CRO), you will join a nationally recognized team coordinating NIH/NINDS funded studies that are changing how ALS is diagnosed, monitored, and ultimately treated.
We are seeking a motivated Clinical Research Associate (CRA) to support field monitoring activities across a network of leading academic medical centers participating in innovative ALS clinical research studies. This role offers the opportunity to work alongside dedicated research sites, while ensuring the highest standards of participant safety, regulatory compliance, and data quality.
As a Clinical Research Professional, 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.
Every day you will manage trial activities, including participant recruitment, data collection, and documentation, serving as a key liaison for all stakeholders. You will ensure strict adherence to protocols and regulatory requirements from study initiation to completion.
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.
Position responsibilities include:- 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, and Peurto Rico.
- 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.
- Completion , 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.
