[Hiring] Single Sponsor CRA I / II @Syneos Health

Role Description

The Single Sponsor CRA I / II (Must have UK monitoring exp) is responsible for various site management activities, ensuring compliance with regulatory standards and protocols.

• Performs site qualification, initiation, interim monitoring, management activities, and close-out visits (on-site or remotely).
• Evaluates overall performance of site and site staff, providing recommendations for site-specific actions.
• Maintains knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
• Verifies informed consent process and protects subject/patient confidentiality.
• Assesses factors affecting subject/patient safety and clinical data integrity.
• Conducts Source Document Review and verifies clinical data accuracy in case report forms (CRF).
• Utilizes hardware and software for effective clinical study data review and capture.
• May perform investigational product (IP) inventory and reconciliation.
• Reviews Investigator Site File (ISF) for accuracy and completeness.
• Documents activities via confirmation letters, trip reports, and communication logs.
• Supports subject/patient recruitment and retention strategies.
• Understands project scope, budgets, and timelines; manages site-level activities.
• Acts as primary liaison with study site personnel or in collaboration with Central Monitoring Associate.
• Prepares for and attends Investigator Meetings and global clinical monitoring/project staff meetings.
• Provides guidance towards audit readiness standards and supports audit preparation.
• Maintains knowledge of ICH/GCP Guidelines and completes assigned training.
• Supports site throughout the study lifecycle and may train junior staff.
• Identifies and communicates out of scope activities to Lead CRA/Project Manager.

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 applicable 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.

Requirements

• Compliance with site requests for medical and personal information for facility access.
• Failure to provide requested information may risk 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.

Company Description

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

• Worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years.
• Involved in over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
• Encourages initiative and challenges the status quo in a competitive environment.