Clinical Research Coordinator II (Non-RN)
Core
Coordinate care for patients on complex clinical research protocols (Phase 1-3, multi-cohort, interventional) under medical supervision, managing study procedures, data integrity, and regulatory compliance.
Role type
Clinical Research Coordinator II (Non-RN)
Builds
Clinical trial data and patient care records for oncology research studies
Domain
Healthcare / Clinical Research / Oncology
Required skills
Protocol comprehension and implementation, Regulatory compliance (GCP, ICH/FDA), Data collection and integrity, Adverse event reporting, Informed consent processes, Investigational product management, Budget and contract execution, IRB/IEC documentation
Preferred skills
Bachelor's degree, Licensed Practical Nurse (LPN) certification, Electronic Medical Records (EMR) experience, Clinical Trial Data Entry Systems (EDC) experience, Clinical Trial Management Systems (CTMS) experience
Technologies
MS Office (Word, Excel, PowerPoint, Outlook), EMR, EDC, CTMS
Responsibilities
Assess subject eligibility based on inclusion/exclusion criteria, Conduct informed consent discussions, Collect and report accurate clinical data, Manage investigational drug inventory and storage, Prepare for and support monitoring visits, Execute study budgets and billing compliance
Seniority
Mid-level, independent execution