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Clinical Study Specialist – AusculSciences Canada Inc. (Kanata, Ontario location).

Posted: June 1, 2017 at 5:20 pm   /   by   /   comments (0)

Clinical Study Specialist

AusculSciences Canada Inc. is seeking a full time Clinical Study Specialist for its Kanata, Ontario location.

Send Application:
Interested candidates may please send their resumes with Salary Expectation and References to:

Careers@ausculsciences.com

Responsibilities:

The Clinical Study Specialist plays a key role in the development, coordination and project management of clinical trials from protocol development through to ethics approval, activation, follow-up and closure. This role is responsible for projects involving various company initiated cardiovascular diagnostic devices trials.  The position will report to the company’s Regulatory Affairs Director.   Principal responsibilities will include:

  • Project management of single and multi-centre studies
  • Contributing to clinical trial / research protocol development and amendments
  • In conjunction with study principal investigators, implementation and compliance with all legal, contractual and protocol requirements related to clinical trials and research
  • Site Management including qualification, operator training, monitoring, analysis, and reporting
  • Communication with clinical study sites, principal investigators, physicians, nurses, research coordinators, external stakeholders and vendors
  • Support regulatory submissions related to clinical trials and product registrations and ensure studies are conducted in accordance with ICH-GCP, Health Canada, FDA as well as other regulatory requirements
  • Apply quality assurance procedures, including those required under ISO 13485 and 21CFR Part 820, to ensure that high quality data is obtained and protected.

Qualifications:

Education

  • Undergraduate Science degree or recognized equivalent
  • Strong understanding of biostatistics desired
  • Clinical Research certification preferred

Experience

  • Minimum 5 years’ experience in medical device clinical trials management

Skills & Functional / Technical Competencies

  • Self-motivated with Initiative, good judgment and the ability to multi-task
  • Excellent organization and prioritization skills
  • Able to work in a fast-paced environment while paying close attention to detail
  • Able to problem solve and apply critical thinking
  • Able to learn quickly and work independently
  • Able to produce high quality work while meeting deadlines
  • Able to work well as part of a team
  • Knowledge of applicable legislation and regulations (Health Canada, FDA, CE Mark)
  • Demonstrated proficiency in English, with excellent oral and written communication skills
  • Demonstrated proficiency in MS Office applications

Contact:

Interested candidates may please send their resumes with Salary Expectation and References to:

Careers@ausculsciences.com