Quality and Regulatory Coordinator

3 weeks ago

Calgary, Canada Alberta Health Services Full time

**Your Opportunity**:
The Quality and Regulatory Coordinator will act as an Investigator Initiated Trials Quality and Regulatory Advisor and will provide coordination, project management and oversight of all aspects related to regulatory requirements for Investigator Initiated Trials (IITs) (and other trials as needed) to assure the integrity of the trial with respect to logistics, accuracy, accountability and safety. This position will play an integral role in developing and implementing a quality assurance/regulatory strategy as the Investigator Initiated Trial program continues to expand in the Clinical Research Unit. This position will ensure planning, coordination and continuous improvement of processes and methods established to control the quality of IIT studies being conducted at Tom Baker Cancer Centre (TBCC) and ensure timelines are set and adhered to. This position is crucial to ensuring the success of the TBCC Investigator Initiated Trial Program.

**Description**:

- Classification: Coordinator
- Union: Exempt
- Unit and Program: Clinical Research Unit, TBCC CRU
- Primary Location: Tom Baker Cancer Centre
- Location Details: As Per Location
- Negotiable Location: Within Calgary Zone
- Temporary Employee Class: Temp F/T Benefits
- FTE: 1.00
- Posting End Date: 15-FEB-2023
- Date Available: 06-MAR-2023
- Temporary End Date: 08-MAR-2024
- Hours per Shift: 7.75
- Length of Shift in weeks: 2
- Shifts per cycle: 10
- Shift Pattern: Days
- Days Off: Saturday/Sunday
- Minimum Salary: $28.20
- Maximum Salary: $48.45
- Vehicle Requirement: Not Applicable

**Required Qualifications**:
Undergraduate degree in a related field. Minimum of 5 years clinical trial experience including site coordination of clinical trials. In-depth knowledge of clinical trial and drug development processes including ICH-GCP, FDA and Health Canada regulatory requirements. Demonstrated ability to manage multiple trials and tumor groups as it relates to regulatory compliance and protocol administration and management. Experience with regulatory submission preparation (CTA) to Health Canada Directorates (TPD, NNHPD, BGTD). Experience with protocol development. Working knowledge of AHS research environment. Oncology clinical trial experience. Well-developed interpersonal oral and written communication skills.

**Additional Required Qualifications**:
As required.

**Preferred Qualifications**:
ACRP or SOCRA certification.

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