Clinical Research Coordinator II
This Clinical Research Coordinator II role seeks a highly organized, detail-oriented professional to manage essential aspects of clinical trials. You’ll play a crucial role in patient coordination while assisting in regulatory and administrative compliance, study initiation, maintaining documentation, and accurately reporting adverse events.
The ideal candidate possesses strong communication, critical thinking, and problem-solving skills, with proficiency in MS Office. A Bachelor’s degree and at least three years of combined clinical trial or relevant clinical work experience are required. Oncology experience and phlebotomy skills are a plus.
Qualifications:
- Comprehensive Clinical Trial Management: Proven ability to coordinate and attend study initiation visits, manage all patient activities throughout trial enrollment, and ensure meticulous collection and documentation of source data, including adverse events.
- Expert Regulatory Compliance & Data Integrity: Skilled in maintaining current protocol documentation, managing regulatory files in SharePoint, utilizing Electronic Data Capture (EDC) systems, and addressing monitor queries to ensure data quality and compliance.
- Patient-Centric Coordination & Communication: Proficient in performing informed consent for diverse populations, educating patients on trial requirements, coordinating complex research visits (screening, treatment, tissue collection), and maintaining optimal patient tracking.
- Operational Acumen & Problem-Solving: Adept at creating and following logistical processes for patient onboarding, developing organized source documentation, and applying critical thinking to resolve logistical challenges efficiently.
- Team Collaboration & Technical Proficiency: Effectively collaborates with senior CRCs, investigators, clinic staff, and external partners. Proficient in MS Office tools for communication and organization, with the ability to learn new patient registering systems quickly.