Your Opportunity:
Are you an experienced clinical trial professional? If so, you may be the person we\'re looking for. The Clinical Trials Coordinator coordinates & assists with study activities within various areas of the Unit. This position will be assigned to our Trial Launch Team (TLT) primarily but may assist other tumor groups as required. They report to the CTU Manager and are responsible for facilitating clinical trial processes and completing delegated study tasks. Responsibilities include: Preparing REB application submissions, amendments and progress reports. Draft, negotiate and finalize Informed Consent Forms, liaising with Industry partners on ICF content and ethics submission timelines. Develop and maintain strong relationship(s) with PI\'s, hospital personnel and representatives from outside agencies regarding ongoing conduct of clinical research. Complete and maintain regulatory forms and critical documents. Develop a system to organize, plan and track workflow related to clinical trial activities to ensure timely documentation and data submissions. Other duties may include abstracting 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, report and maintain various study metrics. Coordinate monitoring visits, and assist with site audits, and regulatory inspections. Registering patients, inform appropriate personnel of assigned study treatment, notify team of communications regarding adverse drug reaction reports, and ensuring safety documentation is completed.
Description:
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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