Research Coordinator

• Advocate for patient safety and protocol integrity
• Conduct patient screening and schedule and oversee on-study requirements
• Attend study teleconferences with sponsors and clinical research organizations
• Identify study objectives and outcome measures
• Adhere to federal, state, institutional, and NEXT Oncology research regulations, policies, procedures, and SOPs
• Communicate with interdisciplinary teams to ensure protocol compliance and timelines
• Collaborate with investigators, pharmacy, and personnel regarding study drugs
• Provide protocol-specific education to clinical staff
• Prepare for and conduct meetings and teleconferences with sponsors, monitors, and auditors
• Report serious adverse events, unanticipated problems, deviations, violations, and noncompliance
• Support informed consent and re-consenting processes
• Determine patient eligibility and educate patients and families about trial participation
• Coordinate protocol-required events, study visits, scans, pharmacokinetic/dynamic assessments, and quality-of-life collections
• Assess patient factors affecting adherence and implement interventions
• Evaluate adherence to protocol agents and treatment requirements
• Collaborate on disease response and treatment schedule or dose modifications
• Document patient encounters and maintain study and source documents
• Obtain outside provider and laboratory documents
• Ensure accurate source documentation and resolve discrepancies
• Maintain patient privacy and confidentiality
• Manage research data, troubleshoot data entry issues, and enter source data into CRFs and electronic data capture systems
• Participate in quality control activities and respond to database and sponsor queries