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About the Role

The Site Data and Regulatory Coordinator provides essential support to the Clinical Research Coordinator and Research Nurse, ensuring all activities adhere to company SOPs and GCP/ICH regulations. This role is crucial for maintaining site compliance by managing regulatory documents and protocol training, preparing for monitoring visits, and collaborating with regulatory affairs, site leadership, and principal investigators to meet strict deadlines.

Responsibilities

• Enter data into study-specific case report forms or electronic data capture systems.
• Resolve queries in electronic data capture systems for assigned clinical trials.
• Work with the Clinical Research Coordinator to meet industry trial data deadlines.
• Establish an effective workflow with the Clinical Research Coordinator to manage clinical trials.
• Obtain source documentation for patients enrolled into clinical trials.
• Assist in SAE reporting and tracking.
• Create and maintain patient visit tracking spreadsheets.
• Create imaging requests, manage imaging tracker, answer queries, and upload images per guidelines.
• Establish and maintain positive relationships with Clinical Research Associates (CRA).
• Investigate and report protocol deviations.
• Maintain and archive study administrative files.
• Maintain assigned closed-to-accrual trials.
• Report required metrics to the leadership team.
• Attend all SIVs for assigned trials.
• Schedule and manage monitor visits, including resolution of follow-up items.
• Assist other colleagues as requested and perform other related work as needed.
• Provide site-level regulatory support for start-up and ongoing regulatory maintenance.
• Establish and maintain a document management system for regulatory paper and electronic files for each study.
• Escort monitors to and from the secured Monitoring Suite area.
• Maintain updated physician credentials and other critical documentation.
• Meet with monitors, study sponsor representatives, and auditors as requested.
• Track documents pending site regulatory signatures.
• Route and track completion of protocol training.
• Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors, and networks.
• Ensure all regulatory documentation is compliant with local SOPs.
• Triage site requests for regulatory support and identify correct pathways for issue resolution.
• Maintain organization of the Regulatory File room, including archiving notebooks.
• Attend network meetings, conference calls, and departmental meetings as appropriate.
• Provide administrative support to the Site Support department.
• Participate in educational activities and programs.

Requirements

• Knowledge of scientific, medical, and regulatory terms preferred.
• Knowledge of GCP and GMP.
• MS Office proficiency.
• 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.

Skills

• Clinical trial databases
• Electronic data capture
• Microsoft Office (Outlook, Word, Excel, and PowerPoint)
• SharePoint

Location

• Remote

Work Type

• Full-time

Experience Level

• Not specified

Education Level

• Not specified

Salary/Compensations

• Competitive compensation package determined by performance, experience, skills, equity, market evaluations, and geographical markets.
• Potential for annual bonus or long-term incentive opportunities.

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.

About the Company

• Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials.
• SCRI is focused on advancing therapies for patients and is a leader in drug development.
• SCRI formed a joint venture with former US Oncology Research to expand clinical trial access.
• SCRI has conducted over 850 first-in-human clinical trials and contributed to pivotal research leading to FDA-approved cancer therapies.
• SCRI's research network includes over 1,300 physicians enrolling patients at over 200 locations in 20+ states.

Equal Opportunity

• We are an equal opportunity employer and value diversity at our company.
• We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.