Clinical Research Coordinator II

Position Summary

We are seeking an experienced Clinical Research Coordinator II to support oncology clinical trials within our Pediatric Oncology Research Program. This role is responsible for coordinating complex clinical studies, ensuring regulatory compliance, supporting patient enrollment and follow-up, and collaborating with investigators, research staff, sponsors, and study participants.

Key Responsibilities

• Cover, recruit, consent, and follow study participants.
• Review study protocols and ensure compliance with research requirements.
• Prepare and submit regulatory documents to IRBs and sponsors.
• Maintain study records, source documentation, and regulatory files.
• Report adverse events, serious adverse events, and protocol deviations.
• Complete data entry and manage study information within electronic systems.
• Collaborate with investigators, research nurses, sponsors, and other study team members.

Required Qualifications

• Bachelor’s degree in a health science, biological science, nursing, public health, or related field.
• Clinical research coordination experience, preferably with interventional clinical trials.
• Knowledge of Good Clinical Practice (GCP), FDA regulations, informed consent, and IRB processes.
• Strong organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Oncology or pediatric oncology research experience.
• Experience with regulatory submissions and compliance.
• Clinical research certification (CCRC, CCRP, or equivalent).
• Experience using EPIC, OnCore, REDCap, Rave, Veeva Vault, or similar research systems.