Clinical Research Coordinator II

This Satellite Clinical Research Coordinator position will work within the Dana-Farber Attleboro Satellite location supporting the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI disease programs.

The Satellite CRC will be responsible for the primary data collection, management of patient clinical information, and regulatory documents as it pertains to participation in clinical trials across all studies open at the Satellite site(s). Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains site regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for site IRB submissions (violations, deviations, severe adverse event reports). This individual may also screen patients for protocol eligibility, obtain informed consent (minimal risk studies), and register study participants to clinical trials. Travel to the Longwood campus and other DFCI Satellite sites may be required. Position located at Attleboro campus.

• Demonstrates understanding of CRF completion, including timely and accurate transcription of study data
• Shows an understanding in coordinating and managing clinical research studies
• Shows an understanding of ICH/GCP and Federal Regulatory requirements
• Shows an understanding of DF/HCC SOPs
• Shows an understanding of the roles and responsibilities of other key departments within clinical research (ex. OHRS, ODQ, DFCI CTO etc.)
• Proficient in understanding of phases of clinical trials
• Ability to work across satellite locations and provide on-site and remote support
• Is competent and autonomous with minimal assistance and supervision

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Excellent organization and communications skills
• Strong interpersonal skills with the ability to effectively interact with all levels of staff and externals contacts
• Must be detail oriented and have the ability to follow-through
• Ability to effectively manage time and prioritize workload
• Must practice discretion and adhere to hospital confidentiality guidelines at all times
• Must have computer skills including the use of Microsoft Office

MINIMUM JOB QUALIFICATIONS:

The position requires a bachelor’s degree and 1 to 3 years of related experience. Experience in a medical, scientific research, or technology-oriented business environment is preferred. The role involves performing primary duties with greater independence and advancing to more complex skill sets as directed.

SUPERVISORY RESPONSIBILITIES:

Orients and assists in training new staff.

PATIENT CONTACT:

Minimal patient contact.