Clinical Trials Specialist

Ozmosis Research Inc.; Toronto; Hybrid; CAD 70,000 - 90,000; Full time

Job summary

Ozmosis Research Inc. is seeking a Clinical Trials Specialist to manage and coordinate clinical trials. The role requires a Bachelor's degree in Science and 4 years of experience in clinical trials management. You will be responsible for protocol development, project management, and ensuring compliance with regulatory standards, while working in a dynamic hybrid environment. A comprehensive compensation package with benefits is offered.

Benefits

Health & dental benefits

Defined benefit pension plan

Qualifications

• Completion of a Bachelor's of Science degree or recognized equivalent required.
• 4 years of experience in clinical trials management preferred.
• SoCRA or ACRP designation is an asset.

Responsibilities

• Participate in the development and coordination of clinical trials from protocol to closure.
• Manage projects, coordinate studies, and ensure regulatory compliance.
• Communicate with various sites, staff, and sponsors.

Skills

Project Management

Regulatory Compliance

Communication

Quality Assurance

Teamwork

Education

Bachelor's of Science degree

Degree or Certificate in Clinical Research

Tools

MS Office Suite

Job description

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

Status: Full Time

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 & dental 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
• 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

• 4 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
• 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)

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 [e-mail].

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Research Services

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