Clinical Research Coordinator - Breast group

Alberta Health Services; Edmonton; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading healthcare organization is seeking a Clinical Research Coordinator to join their Clinical Trials Unit. The role involves facilitating clinical trial processes, preparing regulatory submissions, and maintaining strong relationships with stakeholders. Ideal candidates will have clinical research experience, particularly in oncology, and excellent organizational skills. This position offers a chance to work on cutting-edge cancer therapies in a collaborative environment.

Qualifications

• Minimum of two years' clinical research experience.
• Knowledge of oncology terminology and tumor staging.

Responsibilities

• Prepare REB application submissions and progress reports.
• Coordinate and prepare for monitoring visits and regulatory inspections.
• Identify, collect, and report clinical trial data.

Skills

Oncology

Clinical Research

Multi-tasking

Computer Skills

Education

Two-year diploma in healthcare

Bachelor’s degree in health-related field

Tools

Microsoft Office

InForm

RAVE

Netcare

ARIA

ConnectCare

IRISS

REMO

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’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 CRFs 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 relationships with PIs, hospital personnel, and outside agency representatives regarding ongoing clinical research.
• Register patients, inform personnel of assigned study treatments, notify the team of adverse drug reactions, and ensure safety documentation is completed.
• Assist with Operational Approval submissions and queries.

The initial position will be with our Breast 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 support research studies by:

• Identifying, collecting, and reporting clinical trial data.
• Compiling research reports and regulatory documents as required by protocols and sponsors.
• Ensuring research information is timely, accurate, valid, meaningful, and compliant with regulations.

Additional details include:

• Classification: Clinical Resrch Coord (ACB)
• Union: HSAA Facility PROF/TECH
• Unit and Program: Clinical Trials Unit, Cancer Care
• Location: Cross Cancer Institute
• FTE: 1.00
• Posting End Date: 20-MAY-2025
• Temporary Employee Class: Temp F/T Benefits
• Date Available: 09-JUN-2025
• Temporary End Date: 13-MAR-2026

Required Qualifications:

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

Additional Required Qualifications:

Oncology and general clinical trial experience; experience with breast cancer/disease or trials is an asset. Prior experience working with pharmaceutical sponsors. Ability to multi-task in a busy environment. Knowledge of oncology terminology, anatomy, and tumor staging. ICH-GCP training and familiarity with regulatory reporting. Excellent computer skills, experience with Microsoft Office, spreadsheets, databases (e.g., InForm, RAVE), electronic medical records (e.g., Netcare, ARIA, ConnectCare), and ethics submission systems (IRISS, REMO). Physical ability to transport materials and perform tasks involving lifting, bending, and standing. Please attach a resume and cover letter demonstrating how your education and experience meet these requirements.

Preferred Qualifications:

Bachelor’s degree in a health-related field, completion of a Clinical Research or Data Management Certificate Program, and SoCRA or ACRP certification/membership are preferred.