Clinical Research Associate II (France)

Clinical Research Associate II (France)

This position is primarily a training and development role, supporting and observing clinical site monitoring services both in-house and in the field while developing CRA skills and knowledge. This role will provide exposure and training in all aspects of clinical site monitoring services, while also performing monitoring and site management activities for full-service studies, assessing protocol, SOP, and regulatory compliance.

Responsibilities include:

• Site management activities to drive investigative site and patient recruitment, compliance, and oversight.
• Remote data review, query support, and closure activities.
• Support for Risk-Based Monitoring (RBM) activities.
• Assessment of data collection and (regulatory) document collection.
• Performing remote and onsite activities for investigational sites, including site contacts, qualification, initiation, monitoring, and close-out visits, under supervision and/or independently, in accordance with corporate, sponsor, and regulatory (ICH GCP and other) standards and guidelines.
• Representing the corporation by maintaining collaborative relationships with stakeholders.

Site Management

• Conducts and documents remote site contacts, which may include remote site initiation, monitoring, and close-out visits. Activities are documented per SOPs and study guidance.

• Conducts and documents onsite activities such as feasibility, qualification, initiation, monitoring, and close-out visits under supervision. Activities are documented per SOPs and study guidance.

• Conducts remote data review of EDC, CTMS, RBM, and other clinical systems to ensure alignment with SOPs, study guidelines, and GCP best practices. Identifies trends within and across study sites and escalates findings appropriately.

• Routinely reviews the site section of the TMF for accuracy, timeliness, and completeness. Requests new/updated documents from the site/primary assigned CRA as required.

• Supports CRA II, Snr CRA, and Lead CRA's in day-to-day study management activities.

• Remotely monitors, resolves, and/or facilitates the resolution of queries arising from regular and/or safety reviews, adverse events, and other data management activities throughout the trial.

• Coordinates the delivery of clinical site communications, collaborating with project teams, to ensure investigational sites receive accurate ongoing data, updates, information, and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.

• Supports preparation for audits and required follow-up actions.

Site Setup and Startup Support

• Identifies and recruits site investigators, coordinates the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms, and support tools.

• Ensures SOPs are in place to optimize patient recruitment, providing guidance to site teams on inclusion/exclusion criteria.

Training and Development

• Successfully completes CRA development track activities and milestones.

• Develops and demonstrates competencies required to fulfill the role of a CRA.

• Supports and observes primary assigned CRAs during both onsite and remote visits.

• Supports Lead CRA's with remote site management activities.

• Participates in all study-related activities, including but not limited to trainings, team meetings, and provides any necessary updates to the study team.

Qualifications

• A minimum of a college diploma/degree and 1-3 years of related experience.
• SoCRA, CCRA, and/or ACRP certification/designation is an asset.
• Must exhibit self-motivation with strong communication skills and a commitment to achieving positive results.
• Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
• For one CRA position supporting Flemish sites in Belgium, Dutch language skills are required.

Working Conditions

• Home-based.
• Regular travel.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Positions available: 1 (remote within France)