[Hiring] Senior Clinical Research Associate I @Syneos Health

Role Description

The Sr CRA I will perform various responsibilities related to site qualification, management, and monitoring, ensuring compliance with regulatory standards.

• Performs site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely).
• Uses judgment to evaluate site performance and communicate serious issues to the project team.
• Maintains knowledge of ICH/GCP Guidelines and company SOPs.
• Verifies informed consent processes and protects subject confidentiality.
• Assesses factors affecting subject safety and clinical data integrity.
• Conducts Source Document Review and verifies clinical data accuracy.
• Utilizes hardware/software for effective data review and capture.
• May perform investigational product inventory and reconciliation.
• Routinely reviews the Investigator Site File for accuracy and completeness.
• Documents activities via confirmation letters, trip reports, and communication logs.
• Understands project scope, budgets, and timelines; manages site-level activities.
• May act as primary liaison with project site personnel.
• Prepares for and attends Investigator Meetings and sponsor meetings.
• Provides guidance towards audit readiness standards.
• May provide training or mentorship to junior CRAs.
• May be mentored and assigned clinical operations lead tasks.
• Supports site throughout the study lifecycle from identification to close-out.
• Identifies and communicates out of scope activities to Lead CRA/Project Manager.
• Proactively suggests potential sites based on local knowledge.
• Collaborates with RWLP Regulatory team for updated regulatory information.

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 regulatory requirements.
• Demonstrates good computer skills and embraces new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.

• We are passionate about developing our people through career development and progression.
• Committed to building an inclusive culture where you can authentically be yourself.
• Continuously building the company we all want to work for and our customers want to work with.