Clinical Research Associate; East Coast - US Region

Position: Clinical Research Associate (East Coast - US Region) Job Summary and Responsibilities 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 northeast and east coast 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! This Clinical Research Associate will report directly to the BNI Clinical Research Organization (CRO) Program Manager. The CRA position will independently be responsible for clinical monitoring activities and overall project administration to oversee the progress of multi-center, investigator initiated, or industry sponsored clinical studies throughout the United States and Canada. The CRA will travel to assigned clinical research sites to conduct approx. 25-30 clinical trial monitoring visits each year, and will also complete remote/centralized monitoring visits to ensure clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines, and all applicable regulatory requirements. The CRA will be responsible for the timely reporting of all monitoring visit findings, and is expected to complete comprehensive monitoring reports and associated deliverables to provide back to the Sponsor and the clinical sites. Additionally, the CRA role will oversee clinical site training activities and, conduct remote webinar and onsite protocol training for Physician Site Investigators, Clinical Research Coordinators, Research Nurses, and other delegated healthcare study personnel. The CRA will be responsible for managing all monitoring visit travel arrangements and travel expense reporting activities in accordance with Dignity Health’s travel and expense purchasing policy. The CRA role will actively participate in departmental quality control and program development activities as directed by the BNI CRO Program Manager.

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.

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.

Job Requirements Minimum Required 2-3 years of… Apply tot his job Apply To this Job