SrCRAI

The Senior Clinical Research Associate (SrCRA) at Syneos Health supports clinical trial site management, monitoring, and compliance to ensure regulatory adherence and data integrity. The role involves site visits, data review, and collaboration with project teams, suitable for candidates with a background in clinical research or related fields.

Location: Remote (US)

Responsibilities

• Performs site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with regulatory standards.
• Verifies informed consent process and protects patient confidentiality.
• Reviews source documents and medical records, verifies data accuracy, and manages query resolution.
• Performs investigational product inventory, reconciliation, and verifies proper dispensing.
• Reviews Investigator Site Files and ensures document archiving.
• Documents activities and supports patient recruitment and retention.
• Manages site activities, communication, and ensures project objectives are met.
• Acts as liaison with site personnel and ensures training and compliance.
• Prepares for and attends meetings, supports audit readiness, and may mentor junior staff.
• Supports study lifecycle activities, collaborates with stakeholders, and identifies process improvements.

Requirements

• Bachelor’s degree or RN in a related field or equivalent experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
• Good computer skills and adaptability to new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to travel up to 75% regularly.