Field Clinical Research Associate, French Speaking

Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.

Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.

May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.

Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.

Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.

Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.

Performs study-related training.

Manages the development and maintenance of study documents, processes and systems as assigned.

Ensures quality and completeness of central and site master files.

Tracks and maintains required study documents, performs quality control review, manages renewals.

Tracks study site and overall study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.

Attends internal and external meetings as required.

Provides all job-related progress reports and visit documentation as required.

May support safety activities such as narrative writing, managing the CEC/DSMB, etc.

OUS: Prepares and coordinates submissions to regulatory authorities.

May perform other activities as assigned.

Requirements

• Must be fluent in French residing in one of the locations noted above preference is the UK given our client portfolio.
• Fluency in English and local language, if different, required.
• Higher education degree or equivalent education, training, and experience.
• Preferred 2 years clinical trial experience or medical device.
• Required 3-5 years monitoring experience.
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinical research processes and regulations.
• Certifications such as Society of Clinical Research Associates (So CRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.
• Core Competencies

Demonstrates expertise in clinical trial monitoring, ensuring compliance with Good Clinical Practice (GCP) and applicable regulations.

Proficient in managing study documents, site communications, and metrics tracking while maintaining high standards of quality and organization.

• Highest-signal resume keywords
• Clinical Trial Monitoring
• Good Clinical Practice (GCP)
• Fluency in French
• Study Document Management
• Organizational Skills
• ATS Optimization Keywords
• Hard Skills
• Clinical Research Processes
• Site Monitoring
• Quality Control Review
• Study Metrics Tracking
• Site Qualification
• Site Initiation
• Site Close-Out Monitoring
• Adverse Event Tracking
• Study Start-Up Activities
• Narrative Writing
• Soft Skills
• Verbal Communication
• Written Communication
• Independence
• Collaboration

Certifications & Qualifications

• Society of Clinical Research Associates (So CRA)
• Association of Clinical Research Professionals (ACRP)
• Industry Keywords
• Human Subject Protection
• Regulatory Guidelines
• Clinical Site Monitoring
• Medical Device Experience
• Study Enrollment
• Tools & Technologies
• Trial Master File
• Study Documents
• Quality Review Systems
• #J-18808-Ljbffr