Dana-Farber Cancer Institute
This position will work within the clinical research program and supports the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT).
PRIMARY DUTIES AND RESPONSIBILITIES:
Clinical Research Coordinator
Performs basic technical procedures as directed. Collects medical data from paper and electronic sources, both internal and external. Maintains timely follow-up of protocol patients. Maintains on-going communications with DFCI staff for data collection needs. Accesses demographic and clinical information from the clinical systems. Prepares and submits protocol application packets, amendments to protocols, continuing review forms and adverse event reports to IRB and Sponsor. Prepares summary data reports for manuscripts and presentations. Understands basic principles of human research subject protection. Works independently under general supervision.May handle specimens, including collection, appropriate packing and shipping of specimens in accordance with all safety regulations. May administer Quality of Life surveys and interviews. Participates in Quality Control and Quality Improvement initiatives.
Bachelors Degree preferred. 0-2 years of related experience preferred. Requires close to moderate supervision. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
8:30 - 5:00