Careers

Company Description

Ozmosis Research Inc. is Clinical Trials Management Organization located in Toronto that specializes in the management of oncology clinical trials. We are a trusted partner for both large and small corporations, academic institutions, and investigators. Ozmosis Research Inc. values a collaborative and multidisciplinary approach during all trial phases and is strategically designed to ensure the rapid completion of high quality studies with an emphasis on innovative drug development.

I. JOB SUMMARY

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 preferred
• This role will require the flexibility to work in an environment that is constantly changing and work with a variety of individuals

II. QUALIFICATIONS

Education:

• 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.

Experience:

• 2+ years of clinical research experience
• At minimum, 1 year of clinical research monitoring experience (oncology experience preferred)
• Bilingual (English/French) an asset

Professional Affiliations/Memberships

• SoCRA or ACRP designation preferred

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

OZMOSIS RESEARCH INC. THANKS ALL APPLICANTS, HOWEVER, ONLY THOSE SELECTED FOR AN INTERVIEW WILL BE CONTACTED.

Company Description

Ozmosis Research Inc. is Clinical Trials Management Organization located in Toronto that specializes in the management of oncology clinical trials. We are a trusted partner for both large and small corporations, academic institutions, and investigators. Ozmosis Research Inc. values a collaborative and multidisciplinary approach during all trial phases and is strategically designed to ensure the rapid completion of high quality studies with an emphasis on innovative drug development.

I. JOB SUMMARY

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.
• 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.

II. QUALIFICATIONSEducation

• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent

Experience

• 2 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 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 oncology research forward, we would be interested in hearing from you.

OZMOSIS RESEARCH INC. THANKS ALL APPLICANTS, HOWEVER, ONLY THOSE SELECTED FOR AN INTERVIEW WILL BE CONTACTED.