Job Description

Your Opportunity:

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\xe2\x80\x99re 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 SAE\'s & 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\xe2\x80\x99s 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\xe2\x80\x99s, 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 SAE safety documentation is completed. May assist with Operational Approval submits and queries. This position will support our Gynecology tumor group primarily but may assist or be reassigned to help other groups as needed.

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.

• Classification: Clinical Resrch Coord (ACB)
• Union: HSAA Facility PROF/TECH
• Unit and Program: Clinical Trials Unit, Cancer Care
• Primary Location: Cross Cancer Institute
• Location Details: As Per Location
• Multi-Site: Not Applicable
• FTE: 1.00
• Posting End Date: 28-APR-2023
• Employee Class: Regular Full Time
• Date Available: 19-JUN-2023
• Hours per Shift: 7.75
• Length of Shift in weeks: 2
• Shifts per cycle: 10
• Shift Pattern: Days
• Days Off: Saturday/Sunday
• Minimum Salary: $32.34
• Maximum Salary: $41.21
• Vehicle Requirement: Not Applicable

Required Qualifications: Completion of a minimum two year diploma or certificate in a health care related field. Minimum of two years\' clinical research experience. Additional Required Qualifications: 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 SAE and 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 30 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. Preferred Qualifications: Gynecological experience is an asset. Preference given to those with a Bachelor\xe2\x80\x99s level degree (health-related). Completion of an approved Clinical Research or Data Management Certificate Program. SoCRA or ACRP certification/membership.