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COORDINATOR, CLINICAL TRIALS

12 Month Fixed-Term

 

MAIN RESPONSIBILITIES:

 

  • Execute operational aspects of clinical trials.
  • Prepare supporting documentation for clinical trial applications and research ethics board applications.
  • Consult with study managers to provide expertise on Canadian laws/regulations.
  • Participate in site qualification and initiation visits, including coordinating site start-up activities.
  • Participate and coordinate training on new research studies.
  • Prepare and communicate specifications to relevant internal departments in order to study drugs or other required resources.
  • Prepare metrics and updates for management.
  • Proactively identify potential study issues/risks and recommends/implements solutions.
  • Recommend and implement innovative process ideas to impact clinical trials management.
  • Manage clinical trial monitoring activities ensuring compliance with GCP and applicable regulations.
  • Maintain clinical trial documents in the trial-specific Trial Master File (TMF).
  • Works cross-functionally with regulatory affairs and QA/QC teams to maintain compliant documentation and record keeping. 
  • Must adhere to ICH GCP R2, Aurora’s SOPs and comply with Health Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR). In addition, must adhere to ISO 9001:2015 (Quality Management System), ISO 14001 (Environment Management System) and OHSAS 18001 (Occupational Health and Safety Assessment Series).
  • Where applicable, promote and maintain GMP requirements.
  • Other duties as required.

 

QUALIFICATIONS:

  • Bachelor's in relevant field.
  • CRA/CCRP is an asset. Minimum ability to be certified.
  • Mandatory 3+ years of clinical trial (Phase I-IV) management experience in the pharmaceutical or biotechnology industry.
  • Clinical trial management: 3+ years.
  • Drug development in biotech or pharma environment: 2+ years.
  • BS or BA in relevant discipline.
  • Experience in cannabinoid therapy is a plus.
  • Must have strong knowledge of protocol and drug development processes, including clinical trial design, study implementation, management, and monitoring.
  • Experience in management of vendors and external partners.
  • Requires proven project management skills and leadership ability.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
  • Ability to multi-task and shift priorities quickly.
  • Must have excellent interpersonal, written and verbal communication skills.
  • Knowledge of Health Canada and FDA regulations, ICH guidelines, and GCP governing the conduct of clinical trials, from the perspective of a clinical trial sponsor is a plus.

 

We would like to thank all applicants for their interest but only those selected for an interview will be contacted.

Aurora Cannabis Inc. is an Equal Opportunity Employer.


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