Clinical Research Coordinator - Center of Early Detection & Interception Solid Tumor

Overview

Building upon Dana‑Farber’s deep experience in early cancer detection and treatment, we’ve created a robust, integrated clinical/research program – Centers for Early Detection and Interception. This program brings together Dana‑Farber’s expert clinicians and researchers across all cancer types, working together in a unified, multi‑disciplinary effort that will accelerate progress in early cancer detection and interception. Through this effort, we will help stop cancer earlier, saving more lives, and improving the quality of life for all of those affected by cancer.

The Clinical Research Coordinator (CRC) will be an integral part of the Center of Early Detection & Interception clinical research program and lead recruitment for our research studies on the Longwood campus. This role will support the research team in the execution of clinical trials in accordance with Good Clinical Practice and will operate under guidance of the Principal Investigator(s), the DFCI Clinical Trials Office, and the Clinical Research Director.

The CRC will be responsible for leading patient recruitment and consenting efforts at the Longwood campus, providing timely entry of study data into clinical trials management software, screening for protocol eligibility, and obtaining consent from patients for industry‑sponsored and biobanking studies. The CRC will also be responsible for collecting, compiling, and managing patient clinical information. The CRC will ensure prompt collection and shipment of protocol‑related samples to external entities as necessary.

Responsible for maintaining regulatory binders and assuring study compliance with all state, federal, and IRB mandates. This individual will also register study participants to clinical trials.

Fluency in English and Spanish, Portuguese, Chinese, or Hatian Creole is strongly preferred to support effective communication and engagement with participants.

• Oversight of the clinical trials start‑up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
• Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.
• May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable.
• Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.
• Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial.
• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
• Coordination and management of clinical trials throughout the trial life cycle, 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 collection per trial requirements.
• Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject‑specific information.
• Responsible for data entry of time and effort spent on study‑specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.
• Responsible for data entry of study‑specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.

• Bachelor…