Careers

I. JOB SUMMARY
The Administrative Assistant, Clinical Trails provides administrative clinical research support to the Ozmosis team in conducting & coordinating single and/or multicentre studies.

II. QUALIFICATIONS
• Must have good computer skills and be comfortable with learning how to use new applications and databases
• Some working knowledge of medical terminology and/or clinical trials operations preferred
• Good written and verbal communication skills
• Excellent organizational skills
• Strong attention to detail
• Possess good judgment with the ability to multi-task
• Good time management skills, self-motivated, and the ability to work independently
• High school diploma
• An asset: Completed post-secondary degree/diploma

III. KEY ACCOUNTABILITIES & RESPONSIBILITIES
The key accountabilities and responsibilities listed below that the Administrative Assistant, Clinical Trials is responsible for will vary according to each individual study agreement and according to Ozmosis Research needs.

A. Trial Master File (TMF) Management
 Maintain study files as per Ozmosis SOPs, TMF/eTMF Index, eTMF Plan and client requirements
 Complete activities related to document receipt, tracking and processing
 Responsible for uploading files to eTMF and/or filing in paper TMF, as applicable per trial
 Create TMF structure (either paper or electronic) for studies as needed
 Responsible for the ongoing maintenance of and ensuring completeness of the TMF in conjuction with the applicable project manager. Escalate late or missing documents to the project manager and work to resolve.

B. Study Documents Coordination
 Per direction from Ozmosis Project Manager, prepare and/ or update study documents and tools (eg. Trial Master File, TMF Tracking Tool, training trackers, etc.)
 Assist in the generation and review of study reports
 Provide copies of study documents to Project Manager as requested

C. Study Coordination & Administration
 Assist with general administrative tasks, such as scheduling meetings and invoicing, as applicable and as assigned
 Assist in tracking the status of sites throughout a study
 Participate in internal or external audits and document archiving activities as necessary

Other accountabilities and responsibilities may be required depending on business needs.

Job Title: Clinical Trials Manager

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

Status: Full Time

Level: Minimum 5 Years Experience

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, a defined benefit pension plan, Personal Development Fund, and Flexible Fridays.

RESPONSIBILITIES

The Clinical Trials Manager (CTM) 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 CTM 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:

• Managing and coordinating complex multicentre studies
• Communication & Leadership- collaborating with the following: Sponsor, investigator, site staff, internal Ozmosis team, medical monitor and external vendors
• Protocol development, writing, and amendments
• Project Management- management of study logistics, timelines, and budget
• Regulatory compliance – adhering to ICH GCP, regulatory guidelines, and Ozmosis SOPs
• Site Management
• 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
• Degree or Certificate in Clinical Research, an asset

Experience

• At least 5 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

• Excellent written and verbal communication skills, excellent organization, prioritization skills, project management
• Ability to learn quickly and work independently
• Possess initiative, leadership, and good judgment with the ability to multi-task
• Takes ownership of project and drives timelines forward
• Ability to work under pressure and attention to detail
• 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 ozmcareers@ozmosisresearch.ca.