Single Sponsor CRA I / CRA II or Senior CRA (Must have UK monitoring exp. Phase I exp. preferred)

Single Sponsor CRA I / CRA II or Senior CRA (Must have UK monitoring exp. Phase I exp. preferred)

Updated: Yesterday

Location: London, LND, United Kingdom

Job ID:

Description

Syneos Health is a leading fully integrated life sciences services organization built to accelerate customer success. Our Clinical Solutions team members apply their experience to understand customer needs and represent them in the solutions we shape. This role requires experience in UK monitoring and preferred Phase I monitoring.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close out visits (performed on site or remotely) ensuring regulatory, ICH GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies informed consent procedures, protects confidentiality, and assesses factors that may affect subject safety and data integrity.
• Conducts source document review, verifies clinical data entry, and resolves queries within agreed timelines.
• Performs investigational product inventory, reconciliation and ensures proper dispensing and storage.
• Reviews Investigator Site File for accuracy and reconciles with Trial Master File.
• Documents activities through letters, trip reports, communication logs, and other required project documents.
• Manages site level activities, budgets and timelines, adapting to changing priorities.
• Acts as liaison with site personnel and may collaborate with Central Monitoring Associate.
• Prepares for and attends investigator meetings and sponsor face to face meetings.
• Provides guidance toward audit readiness and supports audit preparations.
• Supports site throughout study lifecycle, potentially training junior staff and identifying out of scope activities.

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 an ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.
• US ONLY: Compliance with Employee Privacy Notice regarding deployment to sites requiring personal information.

Equal Employment Opportunity Statement

We are committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate, to assist employees or applicants to perform the essential functions of the job.