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Clinical Trials Specialist

2 months ago

Toronto, Canada Ozmosis Research Inc. Full time

Ozmosis Research Inc. promotes a strong team environment and is seeking a new valued member of our team. If you have experience in critical care clinical trials management, project management and would appreciate the opportunity to work in a setting that moves critical care research forward, we would be interested in hearing from you.

 

Ozmosis is an independent, entrepreneurial clinical trials management company in Canada operating as a social enterprise (not for profit). We are a trusted partner for biotechnology and pharmaceutical companies as well as academic institutions and investigators, and we have an impressive track record of success in clinical research. We provide our expertise to pharmaceutical and biotechnology companies to help them succeed with the design and implementation of their Phase I, II and III clinical trials. 


Responsibilities

The Clinical Trials Specialist (CTS) participates in project management of clinical trials from protocol development/review and approval through to activation, follow-up and trial closure. The CTS is responsible for a wide variety of projects involving phase I, II, III, and observational trials for various investigator-initiated sponsors, pharmaceutical, and biotechnology companies. Principal responsibilities may include:

 

  • Clinical trial project management
  • Coordinating local and/or international multicentre studies
  • Protocol development, writing, and amendments
  • Site activations, ongoing management and close outs
  • Communication with various stakeholders including sites, staff, and sponsors at all levels
  • Vendor management
  • Utilize quality assurance procedures to ensure that high quality data is obtained
  • Ensuring studies are conducted in accordance with ICH-GCP, Health Canada, FDA and US Federal Code, as well as other regulatory agencies


Qualifications


Education

  • Completion of a Bachelor's of Science degree or recognized equivalent required
  • Completion of a post graduate certificate in Clinical Research or Project Management or recognized equivalent preferred

 

Experience

  • At least 3 years of experience in clinical trials required
  • Experience in some or all of critical care/ICU based research, platform trials, international trial management, and device research preferred

 

Professional Affiliations/Memberships

  • SoCRA or ACRP designation, preferred

 

Skills & Functional/Technical Competencies

  • Experience in project and clinical site management
  • Possess initiative and good judgment with the ability to multi-task
  • Strong critical thinking abilities
  • Ability to work under pressure and attention to detail
  • Demonstrated proficiency in English grammar, with excellent oral and written communication skills
  • Excellent organization and prioritization skills
  • Ability to learn quickly and work independently
  • Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines
  • Ability to work well as part of a team
  • Knowledge of applicable legislation and regulations
  • Demonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint)
  • Experience in REDCap an asset

 

If you have experience in critical care, clinical trials management, project management and would appreciate the opportunity to work in a setting that moves clinical research forward, we would be interested in hearing from you. Please apply directly through LinkedIn. Poster will not be responding to direct messages through LinkedIn.