Dana-Farber Cancer Institute
Clinical Research Coordinator II - Foxborough and South Shore Float
Dana-Farber Cancer Institute, Oklahoma City, Oklahoma, United States
Overview
The Clinical Research Coordinator works within the Dana-Farber Regional Campus clinical research program and supports the research team in the conduct of clinical trials following Good Clinical Practice under the supervision of the Principal Investigator(s) and the DFCI disease programs. The Regional Campus CRC is responsible for primary data collection, management of patient clinical information, and regulatory documents related to participation in clinical trials across all studies at the Regional Campus site(s). They ensure timely collection of protocol-related samples, maintain site regulatory binders, and ensure study compliance with all applicable regulations. They may also handle IRB submissions, screen patients for eligibility, obtain informed consent, and register study participants. Travel to other DFCI campuses may be required.
Located in Boston, Dana-Farber Cancer Institute is a leader in cancer research and patient care, committed to diversity, equity, and inclusion, and works in partnership with Harvard Medical School-affiliated hospitals.
Responsibilities
Oversee the clinical trials regulatory process at the Regional Campus(s) and site activation activities. Coordinate with the lead study team for study start-up, meetings, and project management. Manage data reporting, source documents, adverse events, and study records. Prepare regulatory reports and IRB submissions; maintain study regulatory binders. Track study recruitment, enrollment, and progress using regulatory databases. Ensure proper collection, preparation, and shipping of samples. Prepare for audits and monitoring visits. Manage communication with sponsors and regulatory authorities. Handle trial close-out activities, including contributing to publications and audits. Interact with study participants as required. Support tissue sample work if applicable. Travel between DFCI Regional Campus locations as needed. Perform data entry to support regional activities. Stay updated on current regulations and policies. Prepare and present study status updates at meetings. Clinical Research Coordinator II Understand CRF completion and accurate data transcription. Coordinate and manage clinical research studies. Comprehend ICH/GCP and federal regulatory requirements. Follow DFCI SOPs and understand roles of other departments. Proficient in phases of clinical trials and provide support across locations. Work autonomously with minimal supervision. Qualifications
At Dana-Farber, we foster an inclusive environment where every individual feels they belong. We are committed to diversity and encourage professionals from all backgrounds to apply.
Bachelor's Degree 1 to 3 years of related experience Experience in medical/scientific research or similar technology-oriented environment preferred Ability to work independently and perform advanced skills as directed
Dana-Farber is an equal opportunity employer, affirming the right of all qualified applicants to consideration for employment regardless of protected characteristics. #J-18808-Ljbffr
The Clinical Research Coordinator works within the Dana-Farber Regional Campus clinical research program and supports the research team in the conduct of clinical trials following Good Clinical Practice under the supervision of the Principal Investigator(s) and the DFCI disease programs. The Regional Campus CRC is responsible for primary data collection, management of patient clinical information, and regulatory documents related to participation in clinical trials across all studies at the Regional Campus site(s). They ensure timely collection of protocol-related samples, maintain site regulatory binders, and ensure study compliance with all applicable regulations. They may also handle IRB submissions, screen patients for eligibility, obtain informed consent, and register study participants. Travel to other DFCI campuses may be required.
Located in Boston, Dana-Farber Cancer Institute is a leader in cancer research and patient care, committed to diversity, equity, and inclusion, and works in partnership with Harvard Medical School-affiliated hospitals.
Responsibilities
Oversee the clinical trials regulatory process at the Regional Campus(s) and site activation activities. Coordinate with the lead study team for study start-up, meetings, and project management. Manage data reporting, source documents, adverse events, and study records. Prepare regulatory reports and IRB submissions; maintain study regulatory binders. Track study recruitment, enrollment, and progress using regulatory databases. Ensure proper collection, preparation, and shipping of samples. Prepare for audits and monitoring visits. Manage communication with sponsors and regulatory authorities. Handle trial close-out activities, including contributing to publications and audits. Interact with study participants as required. Support tissue sample work if applicable. Travel between DFCI Regional Campus locations as needed. Perform data entry to support regional activities. Stay updated on current regulations and policies. Prepare and present study status updates at meetings. Clinical Research Coordinator II Understand CRF completion and accurate data transcription. Coordinate and manage clinical research studies. Comprehend ICH/GCP and federal regulatory requirements. Follow DFCI SOPs and understand roles of other departments. Proficient in phases of clinical trials and provide support across locations. Work autonomously with minimal supervision. Qualifications
At Dana-Farber, we foster an inclusive environment where every individual feels they belong. We are committed to diversity and encourage professionals from all backgrounds to apply.
Bachelor's Degree 1 to 3 years of related experience Experience in medical/scientific research or similar technology-oriented environment preferred Ability to work independently and perform advanced skills as directed
Dana-Farber is an equal opportunity employer, affirming the right of all qualified applicants to consideration for employment regardless of protected characteristics. #J-18808-Ljbffr