Clinical Research Associate

6 days ago

Ottawa, Canada TFS HealthScience Full time

**Join Our Team as a** **Clinical Research Associate**

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

**About this role**

The Clinical Research Associate** **is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements. The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out).

As part of our **SRS** team you will be dedicated to one sponsor, a global pharmaceutical company and focus on Ophthalmology.

**This is a part time position for around 35 hours per month.**

**Key Responsibilities**:

- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company
- Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
- Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA
- Initiates corrective action to resolve issues as directed by supervisor
- Participate in contract handling and negotiation directed by Lead CRA/Project Manager
- Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
- In cooperation with study team, responsible for SMF maintenance

**Qualifications**:

- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Minimum 1-3 years of relevant clinical experience
- Able to work in a fast paced environment with changing priorities
- Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guideline

**What We Offer**

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

**A Bit More About Us**

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our cores values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unifed force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. **Together we make a difference

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