Clinical Research Specialist

Under the direct supervision of the Clinical Operations Director, 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).

Responsibilities

• Oversee and coordinate clinical trials of the Lallemand Health Solutions clinical portfolio;
• Evaluate and manage project budgets and resources;
• Take part in the writing and/or revise protocols and other study related documents (Case Report Forms (CRFs), Informed Consent Forms (ICFs), Statistical Analysis Plan (SAP), etc.);
• Support preparation of institutional review board (IRB)/independent ethics committee (IEC) documentation and regulatory applications to ensure clinical trial approval;
• Provide administrative support to clinical projects (i.e.; contract negotiations, grant applications)
• Coordinate the supply of Investigational Products (IP) and other study supplies to the clinical site(s);
• Perform search and evaluation of Clinical Research Organizations (CROs), clinical sites, universities or Principal Investigators for potential trials;
• Prepare and perform continuous monitoring during the study (i.e.; Site Initiation Visits (SIV), Monitoring Visits (MV), Close Out Visits (COV), monthly updates reports) of CROs, clinical sites, or universities to ensure the conduct of the trial is in accordance with approved protocol/amendments and following GCP requirements;
• Write monitoring reports to document site visits and findings;
• Coordinate the analysis of study samples;
• Take part in analysis of the study results;
• Coordinate the redaction of study reports 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 Operations Director.

Requirements

• M.Sc. or Specialty Diploma in Clinical Research Assistant School or related field;
• Previous clinical research experience preferred;
• Knowledge of guidelines and regulations regarding Good Clinical Practice (GCP) and clinical trial regulations in Canada and USA;
• Ability to write scientific reports and excellent oral and written communication skills in English and French;
• Attention to detail and ability to work independently;
• Possess excellent organization, project management and critical thinking skills.

Work conditions

• Workplace: 6100 Avenue Royalmount, Montreal (Quebec) H4P 2R2;
• Possibility of partial remote work;
• 37.5/hours per week from Monday to Friday (flexible schedule);
• Salary according to experience;
• Group Insurance Plan and Registered Pension Plan.

Note: The use of the masculine is used without discrimination and in order to lighten the text.