Clinical Research Coordinator II - Foxborough

Dana-Farber Cancer Institute•Foxborough, MA

5d•$56,000 - $62,700

About The Position

The Clinical Research Coordinator (CRC) will work within the Dana-Farber Regional Campus clinical research program and support the 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 Regional Campus 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 Regional Campus 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 Regional Campus sites may be required. This role will be based at the Foxborough location and travel to the Weymouth location 1-2 times per month. Travel to the Longwood campus and other regional sites maybe required. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. 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

Requirements

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
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
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

Responsibilities

primary data collection
management of patient clinical information
regulatory documents as it pertains to participation in clinical trials across all studies open at the Regional Campus 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)
screen patients for protocol eligibility
obtain informed consent (minimal risk studies)
register study participants to clinical trials
Orients and assists in training new staff