Clinical Research Coordinator - Lung Group

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 Research 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. May assist with Operational Approval submits and queries. The initial position assignment will be with our Lung tumor group however positions within the Unit may assist or be reassigned to other tumor groups as required.

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.

Completion of a minimum two year diploma or certificate in a health care related field. Minimum of two years' clinical research experience.

Oncology and general clinical trial experience required; experience with lung disease or trials is an asset. Prior experience working with pharmaceutical sponsors. An ability to multi-task effectively in a busy area with multiple interruptions and competing demands. Knowledge of oncology medical terminology, anatomy and tumor staging. ICH-GCP training and familiarity with clinical trial regulatory reporting requirements. Excellent computer skills and experience working with Microsoft Office programs. Familiar with using and creating spreadsheets, and using various databases (e.g. InForm, RAVE). Experience with electronic medical records (e.g. Netcare, ARIA, ConnectCare), and ethics submission systems (IRISS, REMO). Must be able to transport large volumes of materials (study supplies, charts, boxes, etc.) to various areas regularly and push/pull loaded carts. Physical demands of the job include sitting for extended periods, lifting office/medical supplies and equipment weighing up to 35 lbs., and using repetitive motions, lifting, bending, reaching and standing for prolonged periods. To ensure your skills and qualifications are considered, please attach a resume and cover letter with your application indicating how your education and experience meets requirements of this position.

Preference given to those with a bachelor’s level degree (health-related). Completion of an approved Clinical Research or Data Management Certificate Program. SoCRA or ACRP certification/membership.