[Hiring] CRA II - Sponsor dedicated - Onco-hematology @Syneos Health

Role Description

The CRA II - Sponsor dedicated - Onco-hematology is responsible for performing site qualification, initiation, monitoring, management activities, and close-out visits, ensuring compliance with regulatory standards.

• Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (on-site or remotely).
• Ensures regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance.
• Evaluates site performance and communicates serious issues to the project team.
• Maintains knowledge of ICH/GCP Guidelines, relevant regulations, 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 in case report forms (CRFs).
• Utilizes hardware and software for effective clinical study data review and capture.
• May perform investigational product (IP) inventory and reconciliation.
• Ensures compliance with electronic data capture requirements.
• Reviews the Investigator Site File (ISF) for accuracy and completeness.
• Documents activities via confirmation letters, trip reports, and communication logs.
• Supports subject recruitment, retention, and awareness strategies.
• Manages site-level activities to meet project objectives and timelines.
• Acts as primary liaison with study site personnel.
• Prepares for and attends Investigator Meetings and clinical training sessions.
• Provides guidance towards audit readiness standards.
• Supports site throughout the study lifecycle from identification through close-out.
• Collaborates with Sponsor affiliates and local country staff.
• May train junior staff and suggest potential sites based on local knowledge.

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 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

• As part of your employment with Syneos Health, you may be deployed to Sites requiring certain medical and personal information for facility access.
• Compliance with Site requests for additional information is required for ongoing 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 building an inclusive culture.