JOB POSTING: Clinical Research Associate C17-PROFYLE

Job Classification:  Clinical Research Associate
Department: C17 – Terry Fox PROFYLE
Location:  Edmonton Clinic Health Academy (ECHA)
Estimated FTE:  0.6 – 1.0 FTE Temporary until 31 March 2017
Hours of Work: Flexible
Salary:  $25-30/hour based on experience

 

The Terry Fox PROFYLE program is a collaborative platform being established in pediatric research centres across Canada to molecularly profile the genome of tumours in young Canadian cancer patients. The C17 Council (C17) represents all Hematology and Oncology Programs at children’s cancer centres across Canada, and will be hosting the PROFYLE CRA in their Edmonton office and will provide some guidance. The PROFYLE CRA will assist in the establishment of the fundamental components of clinical trial aspect of the Terry Fox PROFYLE program.

Duties:

  1. Develop a generic protocol for the PROFYLE clinical trial, including:
    • Research and help write Protocol background
    • Create a suite of clinical trial protocols that may be utilized
    • Establish an appropriate SAE, ADR, SUSAR reporting framework
    • Modify the C17 monitoring program for PROFYLE
    • Create templates for QI labelling
    • Write Informed Consent and Assent documents
  2. Identify appropriate drugs to be considered for PROFYLE, including:
    • Identify source and cost of drugs, including available generics
    • Help network with pharmaceutical companies and contacts
    • Search and identify protocols for N of 1, Phase I/II pediatric and adult studies currently open, find treatment protocols, basket trials
  3. Liaise with Health Canada:
    • Establish BGTD and TPD contacts
    • Start pre-CTA discussions and arrange a pre-CTA meeting, if needed
    • Submit Clinical Trial Application (CTA) to Health Canada for generic protocol with up to 10 pre-approved clinical trials treatment plans
  4. Modify the C17 Terms of Reference, personnel and reporting templates for PROFYLE DSMC
  5. Study Start-Up:
    • Identification of study start-up process and requirements
    • Provide study documents and tools
    • Create training slide deck
  6. Advocacy:
    • Understand issues of access and payment for research drugs. SAP access,                          compassionate use supply
  7. Create a clinical trial node budget for PROFYLE

 

Applications may be forwarded to:

Kathy Brodeur-Robb, Executive Director, C17 Council
Emailed to: kathy.brodeur-robb@albertahealthservices.ca
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