Cette offre d'emploi est expirée.

Clinical Research Associate

7 octobre 2019
Industries Pharmaceutique, Biotechnologie
Catégories Données cliniques, Statistiques, Biostatistiques, Laboratoire, Recherches clinique
Laval, QC

BELLUS Health is recruiting for a Clinical Research Associate (CRA) to coordinate and monitor the progress of important clinical trials on exciting company products. Recently listed on the NASDAQ (BLU), BELLUS is well positioned to offer innovative solutions with the support of a qualified and dedicated team. We are currently recruiting for several positions as the company evolves, and we look forward to exploring a mutually rewarding collaboration with you. Contact us today! 

Position Location: Montreal (Laval) or Eastern US

Position Summary:

Under the direction of the Sr. Director, Clinical Development & Regulatory Affairs the Clinical Research Associate (CRA) works in close collaboration with the Sr. Director, Clinical Development & Regulatory Affairs, Sr. Director, Drug Development, the CROs and the Clinical Trial Manager.

Essential Duties and Responsibilities: 

  • Participates in the coordination and implementation of the local, national and/or international single or multi-center studies.
  • Coordinates all aspects of the clinical monitoring process (including overseeing the activities of independent monitors/CROs) in accordance with good clinical practice (GCP) and BELLUS' standard operating procedures (SOPs). 
  • Conducts and/or oversees pre-study, initiation, interim and close-out site visits.
  • Prepares and/or reviews accurate and timely monitoring visit reports and site corrective actions to ensure effective resolution. Ensures subject's confidentiality and compliance with the patient-consent process.
  • Manages and/or oversees IP receipt, dispensing, inventory and reconciliation. 
  • Ensures SAEs, and AEs are reported within the required timeframe.
  • Assists in gathering and the preparation of documents for clinical trial applications for the submission and approval from the competent authority and ethical committees.
  • Reports on the progress of the studies on an ongoing basis, engaging the Clinical Trial Manager in assisting with the resolution of more complex issues.
  • Supervises and coordinates with contract research organizations (CROs) and other vendors particularly in the monitoring aspect during the conduct of trials.
  • Contributes to the preparation and revision of documents (Monitoring Plan, CRF design, ICF, Protocol, Amendments, study related forms, etc.) and reviews study related documents from CROs (Master Services Agreement, Budget and Work Order for external vendors, Data Validation Guidelines for Data Management, etc.).
  • Represents BELLUS in the global medical research community and develops collaborative relationships with investigative sites and client company personnel. Conducts and reviews clinical studies. 
  • Reviews investigator's study files for audit or inspection and participate in audits as needed.
  • Processes Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study. Participates inthe co-ordination, ordering/dispatching and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate. 
  • Assists clinical research/drug development members with trial progress tracking by updating the Clinical Trial Management systems. 
  • Copies and routes incoming correspondence, internal documentation, CRFs, etc., as appropriate. 
  • Assists in co-ordination of Investigator payments, review of CRA expenses report as needed. 
  • Establishes and maintains effective oral and written communication with investigators and site staff. 
  • Frequent traveling (40%-60% of time), mostly in the United States, Europe and Canada.
  • Assists in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations. 

Education/Experience:

  • A Bachelor's degree in Science or related field or a certification in a related allied health profession.
  • CRA certification is an asset.
  • A minimum of three (3) years experience in clinical trials as CRA.
  • Knowledge of Food and Drug Administration (FDA) European, and Health Canada regulations, International Conference on Harmonization (ICH) requirements and GCP, as well as pre-clinical, clinical and regulatory components in the pharmaceutical industry is required.
  • Knowledge of Respiratory & Dermatology diseases is considered a strong asset.
  • Strong communication skills in both written and spoken English and a good understanding of medical terminology to effectively communicate with medical personnel is required. Fluency in spoken and written French is also an asset in the role.
  • Team player capable of working independently when required, customer-focused, detail-oriented and capable of adapting to different situations.
  • The successful candidate will demonstrate a professional attitude, strong attention to details, initiative, autonomy, flexibility and team spirit.

Knowledge, Skills and Abilities:

  • Relevant work experience in pharmaceutical or biotechnology industry.
  • Good organizational skills, ability to manage multiple tasks and meticulous attention to details. 
  • Impeccable grammar in English is required for this position. Fluency in spoken and written French is also an asset in the role.
  • Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint, Outlook and the Internet.
  • Ability to prioritize and manage personal effort and time accordingly.
  • Excellent interpersonal skills and ability to work cohesively in team settings.
  • Initiative and creativity.

Please submit your resume via this website. 

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