Bilingual Clinical Research Monitor (CRA)
Medtronic
Montreal, Quebec, Canada
1d ago

Responsibilities may include the following and other duties may be assigned.

  • Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
  • Develops and maintains liaison with clinical investigators, clinical research organizations (CO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
  • Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
  • May assist with design, development, and monitoring of clinical evaluation projects.
  • Trains investigators and site personnel.
  • Includes headquarter and field clinical research associates (CORA).
  • Implements and prepares the clinical development strategy as outlined by the clinical teams.
  • May contact and recommend qualified investigators to perform studies and initiate clinical trials.
  • Ensures recruitment and retention of patients.
  • Must Have : Minimum Requirements

  • Bachelors Degree is required.
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
  • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
  • High attention to detail and accuracy.
  • Excellent problem-solving skills.
  • Capable of clearly and effectively communicating verbally and in writing.
  • Excellent interpersonal skills and be a team player (in a virtual environment).
  • Capable to work independently.
  • Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel).
  • Nice to Have

  • Bachelor’s Degree in (medical) sciences.
  • Experience working in a medical environment or involved in executing or monitoring clinical studies.
  • Experience working in a team / matrix environment requiring strong working relationships.
  • Ability to handle and prioritize multiple therapeutic areas and projects simultaneously.
  • Ability to work in a fast-paced environment.
  • Competencies and essential skills in the following : cross functional relationships, decision making, execution / results / process improvement, customer satisfaction.
  • Basic understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)
  • Business knowledge or experience with the medical / healthcare industry.
  • Class III medical device and / or phase II, III and IV pharmaceutical experience.
  • Experience of conducting clinical research activities in a regulated environment.
  • Proficient knowledge of medical terminology.
  • Regulations / standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)
  • Scientific / clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training).
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