About this role
About the Role The Clinical Research Coordinator II (CRC II) will support the Dana-Farber Foxborough Satellite clinical research program and assist the research team in conducting clinical trials under Good Clinical Practice (GCP). The Satellite CRC will manage primary data collection, patient information, and regulatory documents across studies opened at Satellite site(s), ensuring timely protocol-related sample collection and regulatory compliance. Travel to the Longwood campus and other DFCI Satellite sites may be required. What You'll Do
- Manage primary data collection and patient clinical information for trials at the Satellite site(s)
- Maintain site regulatory binders and ensure compliance with state, federal, and IRB requirements
- May be responsible for IRB submissions (violations, deviations, severe adverse event reports)
- Screen patients for protocol eligibility, obtain informed consent (minimal risk studies), and register study participants
- Ensure timely collection, preparation, and shipment of protocol-related samples; adhere to IATA/DOT regulations
- Manage data reporting and management, collection of source documents, case report forms, adverse events reporting, and data queries
- Prepare regulatory-related reports and IRB submissions; maintain organized regulatory binders and data entry
- Coordinate and manage all clinical trials at the Satellite site(s); communicate with Sponsors and regulatory authorities
- Participate in site audits/monitoring visits, close-out activities, and contribute to research articles or meetings as needed
- Travel between DFCI satellite locations to support research activities as coverage requires
- Maintain knowledge of current regulations and local policies; present study status at monthly meetings What We're Looking For
- Understanding of CRF completion and accurate transcription of study data
- Experience coordinating and managing clinical research studies
- Knowledge of ICH/GCP and Federal regulatory requirements
- Familiarity with DF/HCC SOPs and related departments (OHRS, ODQ, DFCI CTO)
- Proficiency in understanding phases of clinical trials and ability to work across satellite locations
- Strong communication and organizational skills; ability to travel between sites as needed Compensation & Benefits
- Salary: $56,000 - $62,700 per year (USD)
- Location: Onsite with occasional remote support as needed across satellite sites
- Benefits information not listed in the posting