About the position
These positions work within the 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 Clinical Trials Office. 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 to clinical trials. Some travel may be required.
Responsibilities
- 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.
- Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
- 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.
- Coordination and management of clinical trials, 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.
- Orients and assists in training new staff.
Requirements
- Bachelor's Degree and 1-3 years of equivalent experience required.
- Bilingual Spanish or Mandarin preferred.
- Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
