[Hiring] CRA I / CRA II - Sponsor Dedicated - Bilingual French and English @Syneos Health

Role Description

The CRA I / CRA II will perform the following responsibilities:

• Conduct site qualification, initiation, interim monitoring, management activities, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol.
• Evaluate overall site performance and provide recommendations regarding site-specific actions, communicating serious issues to the project team.
• Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
• Verify informed consent processes for each subject/patient.
• Protect confidentiality of subjects/patients and assess factors affecting safety and clinical data integrity.
• Conduct Source Document Review and verify clinical data accuracy in case report forms (CRFs).
• Utilize hardware and software for effective clinical study data review and capture.
• Perform investigational product (IP) inventory and ensure compliance with dispensing and administration protocols.
• Review the Investigator Site File (ISF) for accuracy and reconcile with the Trial Master File (TMF).
• Document activities via confirmation letters, trip reports, and other required project documents.
• Support subject/patient recruitment, retention, and awareness strategies.
• Manage site-level activities and communication to meet project objectives and timelines.
• Act as primary liaison with study site personnel and ensure compliance with training requirements.
• Prepare for and attend Investigator Meetings and clinical training sessions.
• Provide guidance towards audit readiness standards and support preparation for audits.
• For Real World Late Phase, support site throughout the study lifecycle and collaborate with Sponsor affiliates.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Requirements

• Compliance with Site requests for medical and personal information for facility access as a condition of employment.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to a Total Self culture.