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Job Information Clinical Research Associate Company Information
Company Perimeter
Contact Name Perimeter
Contact Email hr@perimetermed.com
Since 05-04-2013
Job Information
Job Type Full-Time
Duration
Salary Range Per Month
Department
Category Clinical Research
Sub Category
Shift Morning
Posted 09-01-2017
Requirements
Minimum Education University
Degree Title
Minimum Experience
Work Permit Canada
Required Travel
Job Status
Job Status Sourcing
Start Publishing 09-01-2017
No of Jobs 1
Stop Publishing 15-02-2018
Description

As part of the clinical project team, the clinical research associate will be responsible for developing and supporting clinical trial programs within the commercial organization. The successful applicant will participate in all aspects of ongoing clinical research programs and will be required to deliver on projects with tight timeframes to meet commercial objectives. We are looking for a dynamic team player who possesses experience in advancing clinical trials successfully, with a background in medical imaging and oncology. The individual will bring a robust knowledge of clinical protocol design, experience in working in a multi-site environment, and overseeing implementation and execution of successful clinical trials to the position.

Please note, this is not a research lab environment. We are looking for a strong leader to help us grow our clinical program within our business organization.

Major Responsibilities:

  • Develops a detailed clinical trial project plan, and executes and oversees all aspects of the clinical trial through completion, including but not limited to:
    • conducting on-site qualifications
    • study initiation
    • interim monitoring
    • close-out monitoring
  • conducting on-site qualifications
  • Ensures the identification, recruitment and selection of appropriate clinical investigators and contract research organizations, including appropriate contract negotiation.
  • Aids in development of clinical protocols and preparation of documentation for submission to IRBs/REBs, including but not limited to:
    • drafting Informed Consent Form
    • drafting Clinical Trial Agreement (CTA)
    • negotiating budgets with sites
  • Assists the clinical project team in development of study specific monitoring tools and other related documents as needed.
  • Ensures that all clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solutions in hand to avoid delays in clinical trial implementation.
  • Maintains/reviews regulatory documents as required.
  • Training site staff on protocol/trial procedures.
  • Ensures clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
  • Assists regulatory affairs to ensure the timely preparation of documents to be submitted to the FDA and other health authorities for review.
  • Travel to sites within North America and internationally, as required.
Agreement
Qualifications
  • University Degree, post-graduate work preferred.
Preferred Skills
  • Experience in medical device industry executing on multi-site trials.
  • Experience in a related medical device specialty such as medical imaging, oncology or other related specialty.
  • Experience working with CMS, FDA and Contract Research Organizations (CRO).
  • Medical device industry experience evidenced by successful development, registration, and commercialization of new products.
  • A working knowledge of biostatistics as relevant to the design and analysis of clinical trials is preferred.