May 31, 2022 at 6:58 pm #30381
Are you an experienced clinical trials professional looking for an interesting, challenging position? Do you enjoy working in a team environment on exciting projects involving new cutting-edge cancer therapies? If so, you may be the person we’re looking for to join our Clinical Trials Unit at the Cross Cancer Institute. The Clinical Trials Coordinator reports to the CTU Assistant Manager for administrative functions. They are responsible to the Assistant Manager and Principal Investigator(s) for facilitating clinical trial processes and completing delegated study tasks. Responsibilities may include: Prepare REB application submissions and progress reports, submit IND safety reports and draft study consent forms. Complete and maintain regulatory forms and critical documents/binders for Clinical Trials. Develop a system to organize, plan and track workflow related to clinical trial activities to ensure timely documentation and data submissions. Abstract data to complete study forms, flow sheets, or CRF’s as required by protocol. Review source documents and case report forms with site teams/study representatives and resolve data queries. Prepare and maintain study accrual statistics. Coordinate and prepare for monitoring visits, site audits, and regulatory inspections. Develop and maintain strong relationship(s) with PI’s, hospital personnel and representatives from outside agencies regarding ongoing conduct of clinical research. Register patients and inform appropriate personnel of assigned study treatment, notify team of communications regarding adverse drug reaction reports and ensure safety documentation is completed. Assist with Operational Approval submits and queries. This position will support our Breast tumor group primarily but may assist or be reassigned to help other groups as needed.
As a Clinical Research Coordinator, you will provide support for research studies through the identification, collection, and reporting of clinical trial data. You will compile research, reports and regulatory documents as required by the protocol, and study/sponsor. This involves ensuring research information is timely, accurate, valid, meaningful, and to the sponsor’s satisfaction, and that studies are run according to local and global regulations.
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