The Clinical Research Associate (CRA) will collaborate with and report to the GJCF leadership team and foundation contractors on a multi-center clinical research study titled “Collaborative International Research in Clinical and Longitudinal Experience in NMO Studies (CIRCLES).” The CRA is responsible for the monitoring of sites to assess quantitative and qualitative performance vs. expectations for screening, consent, enrollment and follow up of patients and controls. The CRA will work with the Utah Data Coordinating Center (DCC) to monitor on-site each CIRCLES site’s regulatory compliance and implementation of Good Clinical Practices.
Duties and Responsibilities
Serve as the GJCF reporting point of contact for CIRCLES sites and help to identify any issues or inefficiencies and propose effective solutions to GJCF leadership.
Perform onsite monitoring and source data verification in accordance with ICH Good Clinical Practices, FDA guidelines and local regulations. Expected travel is approximately 50%.
Work with study partners including the DCC and LabCorp to ensure that the study protocol is clearly executed at each site, confirmed at site visits twice per year and monthly calls. Implement remedial measures & monitor closely to ensure compliance.
Review and record each site’s contractual obligations prior to semi-annual site visits. Monitor indicators of site performance and report to GJCF leadership.
Ensure timely resolution of data queries to guarantee reliable clinical data.
Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed. Follow-up with sites until deficiencies are resolved.
Provide timely, quality study metrics to study teams using a variety of tracking tools (tables, databases, spreadsheets and files).
Perform ongoing review of the Trial Master File (TMF) to ensure files are properly maintained and archived
Engage in real-time peer-level relationships with client team/s, including a clinical research consortium, third-party commercial laboratory(ies) and data teams, and other partners to assure timely and accurate implementation of protocols, policies, procedures, and best practices in the CIRCLES study.
Interface with the study biorepository team to ensure seamless operations and communication.
Assist in strategic planning and support quality assurance policies of CIRCLES.
Minimum of 10 years related experience in clinical research.
Minimum of 8 years of experience in monitoring clinical trials.
Demonstrated experience and expertise in the interface of clinical research, laboratory sciences, clinical trials & the industry development process.
Thorough knowledge of good clinical practice (GCP) is required.
Operational knowledge of biorepository science is a plus.
Must have excellent communication skills and outstanding professional diplomacy.
Degrees, Licensure, and/or Certification
Advanced degree in clinical laboratory science, clinical outcomes research, epidemiology, or closely-related field desired.
Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP).
Valid driver’s license and passport
This is a home-based, contracted position, up to 40 hours per week
The Guthy-Jackson Charitable Foundation is dedicated to funding research in the quest to understand the pathophysiology and biochemistry of Neuromyelitis Optica (NMO) Spectrum Disorder. Our Foundation is passionate in its support of programs and opportunities aimed at elevating the clinical paradigm for NMO patients and improving options for treatment, prevention, and an eventual cure for this disease.