Bilingual Sr. Clinical Research Associate

About the Role

We are seeking a Bilingual Senior Clinical Research Associate to join our team in a remote-based capacity within Canada. This is an in-house position designed for a professional who can manage, deliver, and perform full clinical site monitoring services for one or more projects. monitoring services for complex, multinational projects.

As a Lead CRA, you will act as the primary liaison between Clinical Research Associates (CRAs) and the project team. Your role involves the design and oversight of project monitoring services, of project monitoring services, including training, site and patient recruitment, site data and document management, monitoring project site budgets, site budgets, and regulatory filings. You will ensure all activities align with Standard Operating Procedures (SOPs), study guidelines, and Good Clinical Practice (GCP) best practices.

Your Impact

In this subject matter expert capacity, you will mentor, coach, and provide performance feedback to peers. You may assist with the selection, hiring, training, and supervision of CRAs, and training of CRAs, performing co-monitoring and training visits. training visits. When required, you will serve as the first escalation point for resolving site/patient issues or addressing Sponsor concerns.

You will represent the Director of Monitoring and Site Management or the Manager of Clinical Site Management in Business Development initiatives with a site monitoring focus. As the Project Monitoring Lead, you may manage monitoring services for a group of projects and/or CRAs on large/complex projects. This includes directing day-to-day activities and reviewing/approving monitoring reports. You will function as the liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.

You will also play a key role in site recruitment and setup, identifying and recruiting site investigators and coordinating the movement and delivery of trial materials, samples, tests, of trial materials, samples, tests, and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms, CRFs, project documents, forms, and support tools. You will ensure SOPs are in place to optimize patient recruitment, patient recruitment by providing guidance to site teams on inclusion/exclusion criteria.

As the primary clinical site contact, you will oversee the overall integrity of the study to promote positive working relationships with the site and staff. You will facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements. You will ensure all site-related issues are followed until resolution. Additionally, you will coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information, updates, information, and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.

Why Join Us

We value self-motivation, strong communication skills, and a commitment to achieving positive results. We prioritize attention to detail and the importance of building collaborative relationships to achieve results. We encourage critical thinking and the ability to regularly travel to sites.

Working Conditions

This is a home-based position. Regular travel to sites is required.

Compensation

The salary range for this position is $78,000 - $130,000 a year,000 a year, plus bonus.

Stay Alert to Recruitment Scams

We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn't feel right, we encourage you to verify before responding.