The organizational culture at Ozmosis Research can be described as an achievement culture
We value, openness, honesty, and transparency
Process improvements and thinking innovatively are key to the success of the organization
Ozmosis Research is an equal opportunity employer.
We welcome you to send your resume to firstname.lastname@example.org. Please include a cover letter outlining relevant work experience, professional skills, and the position you seek.
We appreciate your interest, however, only candidates selected for an interview will be contacted.
Hours: 35 HRS/week; 9:00-5:00, Monday-Friday
Status: Full Time
Level: Minimum 2 Years Experience
If you have experience in oncology, clinical trials management, project management and would appreciate the opportunity to work in a setting that moves oncology research forward, we would be interested in hearing from you.
Ozmosis Research Inc. is the only 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 oncology 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 oncology experience and our network of contacts at leading oncology centres in Canada, US, and Europe.
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 stakeholders including sites, staff, and sponsors at all levels.
- 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.
- At minimum, completion of a Bachelor’s of Science degree or recognized equivalent
- 2 years experience in some or all of oncology, clinical trials management, project management, regulatory issues involving human subjects, preferred
- 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 oncology, clinical trials management, project management and would appreciate the opportunity to work in a setting that moves oncology research forward, we would be interested in hearing from you. Please submit a cover letter and CV to email@example.com.
Minimum Bachelor’s Degree in Science with post-grad Clinical Research Training or experience
Continuous Training including:
- GCP Training every 2 years
- Ethics & Privacy Training: TCPS2
- Disease Site Oncology Training
- Regulatory Updates
- SOP Training
- Others as needed (Response criteria, correlatives, etc)