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Role Description

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:

• Site Initiation Visits (SIVs)
• Interim and Remote Monitoring Visits
• 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
• 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.
• Work with sites during study start-up, including assessing site feasibility as required, providing 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.
• Evaluate 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.
• Work cooperatively with study team and operations management to proactively drive project success.
• Complete 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.
• Responsible for the timely review of all monitoring deliverables, conduct co-monitoring visits and mentorship of CRA team members.

Qualifications

• Minimum Required: 2-3 years of clinical research experience required or a combination of equivalent experience and education.
• Excellent written/oral communication, interpersonal, and organizational skills required.
• Good presentation skills and ability to effectively communicate information and processes to a variety of audiences.
• Proven attention to detail, excellent problem solving and customer service skills, and ability to multi-task.
• Education: Bachelor's Degree or equivalent combination of education and experience or its international equivalent in clinical, science, or health-related field from an accredited institution required or a healthcare professional licensure such as a Registered Nurse or Physical Therapist.

Requirements

• Ability to travel frequently on domestic and extended trips throughout the United States and Canada (up to 75% of the time), to perform clinical monitoring visits, primarily in the northeast/east coast region.
• Strong interpersonal skills to effectively navigate a matrix organizational structure and effectively lead cross-functional teams.
• Excellent communication skills (verbal and written) to effectively communicate complex information and processes to a variety of audiences.
• Proven attention to detail, with strong analytical, critical thinking, problem solving, time management, and customer service skills.
• Experience with Microsoft Office Suite Systems.

Benefits

• CCRA or CCRP certification preferred.