CRA 1/2, Sr. CRA – Oncology, General Medicine, French Speaking

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document monitoring • Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management • Assist with training of new employees, eg. co-monitoring • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned • Perform other duties as assigned by management

🎯 Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) • 1 - 3+ years of Clinical Monitoring experience • Oncology or ophthalmology experience is desired • Open to various hub locations in Canada • French Speaking preferred

🏖️ Benefits

• Frequent travel to clients/ site locations with occasional travel both domestic and international • Health insurance • Professional development opportunities