Sarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing cancer therapies through community-based clinical trials. The Site Regulatory/Data Coordinator will support the Clinical Research Coordinator and Research Nurse by ensuring compliance with regulatory standards and managing documentation for clinical trials.

Responsibilities
• You will enter data into study specific case report forms or electronic data capture systems for each assigned clinical trial
• You will resolve queries for in electronic data capture systems for each assigned clinical trials
• You will work with the Clinical Research Coordinator to meet industry trial data deadlines
• You will establish an effective workflow with the Clinical Research Coordinator to effectively manage clinical trials
• You will obtain source documentation for patients enrolled into clinical trials
• Assist in SAE reporting and tracking
• You will create and maintain patient visit tracking spreadsheets
• You will create imaging requests, manages imaging tracker, answers queries, and uploads images per imaging guidelines for assigned clinical trials
• You will establish and maintain positive relationship with Clinical Research Associates (CRA)
• You will investigate and report protocol deviations, when applicable
• You will maintain and archive study administrative files
• You will maintain assigned closed to accrual trials
• You will report required metrics to leadership team
• You will attend all SIVs for assigned trials
• You will schedule and manage monitor visits including resolution of follow up items
• You will assist other colleagues as requested and performs other related work as needed
• You will provide site level regulatory support to the site in relation to the status of start-up and ongoing regulatory maintenance
• You will establish and maintain a document management system for regulatory paper and electronic files for each study at the site
• You will escort monitors to and from the secured Monitoring Suite area
• You will maintain updated physician credentials and other critical documentation ensuring compliance
• You will meet with monitors, study sponsor representatives and auditors as requested
• You will track documents pending site regulatory signatures
• You will route and track completion of protocol training
• You will maintain FDA and GCP required regulatory documentation for individual site, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
• You will triage site requests for regulatory support and identifies correct pathway for issue resolution
• You will maintain organization of Regulatory File room, including archiving notebooks as needed
• You will attend network meetings, conference calls and departmental meetings as appropriate
• You will provide administrative support to the Site Support department
• You will participate in educational activities and programs

Skills
• Knowledge of scientific, medical, and regulatory terms
• Knowledge of GCP and GMP
• MS Office
• Professional writing and communication skills
• Organizational and prioritizing capabilities
• Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, Microsoft Office (Outlook, Word, Excel, and PowerPoint) and SharePoint

Benefits
• Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being
• Competitive compensation package
• Annual bonus or long-term incentive opportunities may be offered
• Benefits through our parent company, McKesson

Company Overview
• Sarah Cannon Research Institute is one of the world’s leading oncology research organizations conducting community-based clinical trials. It was founded in 1993, and is headquartered in Nashville, Tennessee, USA, with a workforce of 501-1000 employees. Its website is https://www.scri.com.