Clinical Research Safety Associate

4 weeks ago

Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Clinical Research Safety Associate

Everest Clinical Research Services Inc is seeking a highly skilled and detail-oriented Clinical Research Safety Associate to join our team. As a key member of our clinical research team, you will be responsible for ensuring the safety and well-being of participants in clinical trials.

Key Responsibilities:
  • Serve as the Data Monitoring Committee (DMC) Secretary and perform administrative tasks for assigned projects, including contract negotiations and data report preparation.
  • Support project management of DMC area with activities focused on planning and execution of DMC administration tasks and biostatistical support for these committees.
  • Manage the planning, implementation, conduct, and reporting of assigned projects within established timelines and budgets.
  • Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary.
  • Support medical writing and clinical safety monitoring teams by performing quality control review of document deliverables.
  • Perform data verification (QC) on statistical programming outputs against data source.
  • Learn and perform document e-publishing for clinical trial and regulatory documents.
  • May assist with case processing of safety events from clients' ongoing drug clinical trials.
Qualifications and Experience:
  • M.Sc. or Ph.D. in a clinical or medical or health-related field.
  • At least two years' clinical research experience in an academic, pharmaceutical, or CRO environment.
  • Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device regulations and industry standards.
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
  • Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data.
  • Detail-oriented, customer- and quality-focused.
  • Excellent interpersonal and teamwork skills.

We offer a dynamic and entrepreneurial work environment with opportunities for growth and professional development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.

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