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Clinical Trials Specialist

1 month ago

Toronto, Ontario, Canada Ozmosis Research Inc. Full time

Job Title: Clinical Trials Specialist

Hours: 35 HRS/week; 9:00-5:00, Monday-Friday

Status: Full Time

Level: Minimum 3 Years Experience

Location: Toronto, ON - Hybrid Position

Ozmosis Research Inc. 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. Ozmosis has an impressive track record of success in early phase 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. We offer services provided by traditional CRO's with a distinct advantage – our early phase experience and our network of contacts at leading oncology centres in Canada, US, and Europe.

Ozmosis Research offers a comprehensive compensation package including health benefits and a defined benefit pension plan.

RESPONSIBILITIES

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

  • Project management
  • Coordinating single and/or multicentre studies
  • Protocol development, writing, and amendments
  • Regulatory compliance
  • Site Management
  • Communication with various 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

  • At minimum, completion of a Bachelor's of Science degree or recognized equivalent
  • Degree or Certificate in Clinical Research, an asset

Experience

  • 3 years experience in some or all of oncology, clinical trials management, project management, regulatory issues involving human subjects, preferred

Professional Affiliations/Memberships

  • SoCRA or ACRP designation, preferred

Skills & Functional/Technical Competencies

  • Experience in project management
  • Possess initiative and good judgment with the ability to multi-task
  • Ability to work under pressure and attention to detail
  • Demonstrated proficiency in English grammar, with excellent oral and written communication skills
  • Excellent organization, prioritization skills, and the 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 Medidata Rave an asset

If you have experience in clinical trials management, project management and would appreciate the opportunity to work in a setting that moves research forward, we would be interested in hearing from you. Please submit a CV to