Are you an experienced clinical trial 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 are looking for to join our Clinical Trials Unit at the Cross Cancer Institute. The Clinical Research Coordinator - Clinical Trials reports to the CTU Assistant Manager for administrative functions. They are responsible to the Assistant Manager, 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.
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
Department: ACB REG RES Phase I Gyne Srcm
Primary Location: Cross Cancer Institute
Multi-Site: Not Applicable
Posting End Date: 13-AUG-2020
Temporary Employee Class: Temp F/T Benefits
Date Available: 28-SEP-2020
Temporary End Date: 29-SEP-2021
Hours per Shift: 7.75
Length of Shift in weeks: 2
Shifts per cycle: 10
Shift Pattern: Days
Days Off: Saturday/Sunday
Minimum Salary: $31.01
Maximum Salary: $39.50
Vehicle Requirement: N/A
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:
Recent experience and understanding of the complexities involved in working with pharmaceutical trials & sponsors. Proven ability with previous project coordination requiring effective multi-tasking in a busy area with numerous interruptions and competing demands. Knowledge of oncology medical terminology, anatomy and tumor staging. ICH/ GCP training and familiarity with clinical trial regulatory and safety reporting requirements Proficient with Microsoft office programs. Current experience using electronic health record (ARIA, Netcare) and EDC systems (e.g. InForm, RAVE). Familiar with ethics submission systems and requirements (IRISS, REMO). Able to lift and transport large volumes of charts, binders, lab kits, boxes, etc. to various areas throughout the site on a regular basis – boxes up to 25lbs, push or pull loaded carts.
Preference given to those with a Bachelor’s level degree (health-related). Completion of an approved Clinical Research Program, or related training and experience. SoCRA or ACRP certification/membership.