Quality & Regulatory Advisor

🔍 Edmonton Zone, Edmonton, Cross Cancer Institute

📁: Business Support - Other

📅   : ALB00248805 Requisition #

📅   : Dec 08, 2021 Post Date

Thanks for your interest in the Quality & Regulatory Advisor position. Unfortunately this position has been closed but you can search our 1,860 open jobs by clicking here.

Classification: Coordinator

Union: Exempt

Department: CCI CTU Indirect Cost

Primary Location: Cross Cancer Institute

Negotiable Location: Within Edmonton Zone

Temporary Employee Class: Temp F/T Benefits

FTE: 1.00

Posting End Date: 17-DEC-2021

Date Available: 10-JAN-2022

Temporary End Date: 27-JAN-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: $28.20

Maximum Salary: $48.45

Vehicle Requirement: Not Applicable

Required Qualifications:

Undergraduate degree in a related field. Quality System/Quality Assurance background or training. Familiar with Quality Management Systems, and strong process improvement skills. Experience with regulatory inspections and audit responses (CAPA/root cause analysis.) Minimum of five 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 therapeutic areas/tumor groups as it relates to regulatory compliance, and protocol administration and management.

Additional Required Qualifications:

Clinical Trial Site Monitoring experience. Oncology Clinical Trial experience. Well-developed interpersonal oral and written communication skills. Computer literate in MS Word, Excel, PowerPoint.

Preferred Qualifications:

SOCRA or ACRP Certification. Experience with regulatory submission preparation (CTA) to Health Canada directorates (TPD, NNHPD, BGTD). Experience with protocol development. Working knowledge of AHS research environment.

Please note:

All postings close at 23:59 MT of the posting end date indicated.

Security Screening:

A satisfactory criminal record check and/or Vulnerable Sector Search is required prior to your first day of work. Additionally, all employees have an ongoing duty to disclose any charges or convictions that may occur during their employment with AHS.

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Communities. Together.

We’re passionate about what we do. Our team of skilled and dedicated health care professionals, support staff, and physicians promote wellness and provide health care every day, all across Alberta.

Everything we do at AHS reflects a patient and family centred approach; it’s about putting patients’ and families’ experiences, priorities and trust first.

We are an equal opportunity employer. AHS values the diversity of the people and communities we serve and is committed to attracting, engaging and developing a diverse and inclusive workforce.