Clinical Research Coordinator - Milford

About the role

The Satellite Clinical Research Coordinator (CRC) will work within the Milford Dana-Farber Satellite 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 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).

Responsibilities

• Oversight of the clinical trials regulatory process at the DFCI Satellite(s) and site activation activities
• Communication and coordination with the lead study team at the Longwood campus for study start-up, ongoing study team meetings, and project management of all site study activities
• Responsible for data reporting and management, collection of source documents, use of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries for all studies at the Satellite site(s)
• Prepare and/or complete regulatory related reports and IRB submissions as it pertains to the satellite’s studies. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis
• Maintain various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
• Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations
• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits
• Cordination and management of all clinical trials at the Satellite site(s), including communication with Sponsors and regulatory authorities
• Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved
• Interact with study participants as directed/required by the protocol and/or study team
• May be responsible for tissue sample work
• Travel between DFCI satellite locations to support all above research activities when cross coverage is needed
• Maintain working knowledge of current regulations, regulatory guidance and or local policies
• May be responsible for preparing and presenting study status regulatory status for satellite site clinical team members at monthly research meetings

Qualifications

• The position requires a bachelor’s degree, with 0 to 1 year of related experience preferred. Experience in a medical, scientific research, or technology-oriented business environment is also preferred. The role requires close to moderate supervision.