NCI Specialist

Responsibilities

• NCI Liaison
• Serve as primary communication liaison between research teams and NCI programs to facilitate protocol processes
• Submit Letters of Intent (LOI) and Project Team Member Applications (PTMAs) to NCI
• Coordinate communications with CTEP, CTSU, PMB, and network groups
• Manage communications and submissions to NCI Central IRB (CIRB)
• Participate in multicenter grant-specific and protocol-specific teleconferences
• Absorb with study start-up including Site Initiation Visits and regulatory document review
• Submit required forms and documentation to CIRB
• Maintain lists of new and pipeline ETCTN projects and track enrollment, amendments, and progress
• Report project status updates to Grant Principal Investigator
• Queries, Audit Responses, & Education
• Provide guidance on corrective measures to address audit findings using advanced oncology knowledge
• Interpret complex clinical research issues for investigators and research staff
• Identify quality improvement opportunities and support development of quality initiatives
• Conduct quality assurance reviews to ensure protection of human subjects and data integrity
• Ensure adherence to Good Clinical Practice guidelines, IRB requirements, and SOPs
• Organize and review essential and source documents prior to audit start dates
• Facilitate query responses and address urgent audit-related items in real time
• Develop and review Corrective and Preventive Action Plans (CAPA) with research teams and CRAs
• Prepare and submit audit-related reports to NCI groups
• Quality Assurance
• Evaluate and support clinical research protocols developed through NCI programs
• Review source documentation against Rave system submissions
• Review Serious Adverse Event (SAE) reports and ensure submission timelines to CTEP
• Additional Duties
• Perform other duties as assigned

Education

• Required: A Bachelor's Degree Biological or science related field or a Graduation from an accredited school of professional nursing

Work Experience

• Required: 3 years Clinical research experience as a research nurse/ study coordinator
• Preferred: Experience supporting NCI-sponsored clinical research programs including ETCTN, NCTN, AMC, DCP, or NCORP trials, proficiency in CTSU, Rave, and CIRB systems, experience with CAPA development, quality assurance reviews, and compliance with ICH-GCP guidelines and applicable federal regulations governing clinical research

Licenses and Certifications

• Preferred: CCRP - Certified Clinical Research Professional Upon Hire

Pay

• Minimum $42.79 - Midpoint $53.37 - Maximum $63.94

Schedule

• Hybrid; Onsite presence is required during audits, meetings and additional based on business needs.

Why Us?

• Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
• Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
• Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
• Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.