Clinical Trials Specialist

3 weeks ago

Toronto, 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 2 Years Experience
Location: Toronto, ON
Position: Combination in-office and remote position

Ozmosis promotes a strong team environment and is seeking a new valued member of our team. If you have experience in oncology, 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.

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, 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. We offer services provided by traditional CRO’s with a distinct advantage – our clinical research and oncology experience and our network of contacts at leading centres in Canada, US, and Europe.

RESPONSIBILITIES

The Clinical Trials Specialist (CTS) participates in the development, coordination, data 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 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
At minimum, completion of a Bachelor's of Science degree or recognized equivalent

Experience
At least 2 years of experience in some or all of oncology, clinical trials management, project management, regulatory issues involving human subjects

Professional Affiliations/Memberships
SoCRA or ACRP designation, preferred

Skills & Functional/Technical Competencies
Experience in project and site 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 Oncology and Medidata Rave an asset

If you have experience in oncology, 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.

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