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 email@example.com. 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.
Status: Full Time
Level: Minimum 2 Years Experience
Location: Toronto, ON
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 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 research monitor is responsible for monitoring clinical studies and is a key contact for investigational sites from the pre-study visit until study closure. The monitor is responsible for training site personnel on protocols, CRFs, Good Clinical Practice and performs source data verification while ensuring compliance with GCP guidelines, SOPs and the protocol. Other responsibilities include:
- Ensuring that studies are being conducted in accordance with study protocol, GCP, SOPs and country specific regulations
- Performing source document verification of CRFs
- Conducting drug accountability/reconciliation
- Collection /Review of CRFs and regulatory documents
- Identifying/Resolving problems at the study site to ensure subject safety and data quality
- Conducting pre-investigation, initiation, monitoring and close-out visits
- Travel is required up to 60% of the time, dependent on project needs
- Valid driver’s license and vehicle perferred
- This role will require the flexibilty to work in an environment that is constantaly changing and work with a variety of individual
Skills & Functional/Technical Competencies:
- Demonstrated proficiency in English grammar, with excellent oral and written communication skills
- Excellent organizational and prioritization skills, ability to learn quickly and independently
- Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with Ozmosis standards
- Exercise initiative and good judgment with ability to multi-task
- Ability to work under pressure and close attention to detail
- Knowledge of applicable legislative and regulatory policies
- Demonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint)
- Experience in Medidata Rave an asset
- At a minimum, a completion of a Bachelor’s degree program in a science or health related field, or recognized equivalent required.
- Post Graduate diploma in Clinical Research preferred.
- 2+ years of clinical research experience
- At minimum, 1 year of clinical research monitoring experience (oncology experience preferred)
- Bilingual (English/French) an asset
- SoCRA or ACRP designation preferred
If you have experience in oncology and clinical research monitoring and would appreciate the opportunity to work in a setting that moves oncology research forward, we would be interested in hearing from you at firstname.lastname@example.org.
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)