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Clinical Research Specialist

Lallemand Solutions Santé

This is a Full-time position in Montréal, QC posted October 2, 2018.

Reporting to the Clinical Program Manager, the Clinical Research Specialist (CRS) will be responsible for the oversight of evidence-based clinical trials of Lallemand probiotic strains and yeast formulations. The CRS will also be responsible for managing clinical trial documentation and implementing applicable regulatory requirement(s). Additionally, the CRS will be responsible for ensuring that all clinical trials are conducted in accordance with ethical principles and following the principles of International Conference for Harmonization Good Clinical Practice (ICH GCP).

– Oversee and coordinate clinical trials of the Lallemand Health Solutions clinical portfolio.
– Write protocols and other study related documents (Case Report Forms (CRFs), Informed Consent Forms (ICFs), Statistical Analysis Plan (SAP), etc.).
– Prepare institutional review board (IRB)/independent ethics committee (IEC) documentation and regulatory applications to ensure clinical trial approval.
– Coordinate the supply of Investigational Products (IPs) and other study devices to the clinical site.
– Prepare and perform audits of current and potential Clinical Research Organizations (CROs), clinical sites, or universities to ensure GCP compliance and quality assurance implementation.
– Write audit reports to preserve and value the audit function;
– Follow study progress during intervention period to ensure that all data are reliable and have been processed correctly.
– Prepare internal monthly updates on each project.
– Prepare and conduct monitoring visits to verify that :

  • the rights and well-being of participants are protected,
  • reported trial data are accurate, complete and verifiable from source documents,
  • the conduct of the trial is in accordance with approved protocol/amendments and following GCP requirements.

– Write monitoring visit reports to document site visits and findings.
– Conduct analysis of the study results and prepare study report or manuscripts for publication.
– Present findings at scientific congresses or meetings.
– Design, write and update documentation and templates related to the management of clinical operations.
– Assist with other project management duties as assigned by the Clinical Program Manager.
– Participate in other projects.

 

 

– Minimum of 3 to 5 years of experience in clinical research or in a similar position.
– Knowledge of guidelines and regulations regarding Good Clinical Practice (GCP) and clinical trial regulations. – Ability to write scientific reports and excellent oral and written communication skills in English and French.

Personal strengths required

Attention to detail and ability to work independently.
– Possess excellent organization, project management and critical thinking skills.

Skills Required

  • Education level: University
  • Work experience (years): 3-5 years

Package

Salary: N/D


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