Overview
In this role, you will lead and support site monitoring activities to ensure regulatory and protocol compliance across sponsor-driven studies. You’ll work with cross-functional teams to manage site performance, data integrity, and patient safety, using remote and on-site monitoring as needed. You will contribute to audit readiness and PM/ISF reconciliation, while aligning with ICH-GCP and GMP practices. This is a hands-on, collaborative position with meaningful impact on patient progress and trial success.
Pay / Benefits
- career development and progression
- inclusive culture
- peer recognition
- total rewards program
- technical and therapeutic area training
Responsibilities
- Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) per ICH-GCP/GPP and protocol
- Evaluate site performance and escalate serious issues with actionable plans
- Ensure informed consent, confidentiality, and patient safety considerations
- Conduct CMP/SMP activities including source data review, CRF data accuracy, and query resolution
- Manage IP inventory, dispensing validation, labeling, and storage compliance
- Reconcile ISF with TMF and ensure archiving per local guidelines
- Support subject recruitment and retention strategies; track observations and actions
- Coordinate with Lead CRA and project teams to meet scope, budget, and timelines
- Participate in Investigator Meetings and sponsor meetings; support audit readiness and follow-up actions
- Provide site-level training and ensure compliance with project requirements
- Prepare for real-world late-phase studies and related chart abstraction activities
- Liaise with sponsor affiliates, medical science liaisons, and local country staff
Key requirements
- Bachelor’s degree or RN in related field or equivalent
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Strong computer skills and adaptability to new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to travel up to 75%
- UK on-site monitoring experience (required)
- Excellent communication and interpersonal skills
- Collaborative mindset
- Adaptability to changing priorities
- GCP/ICH guidelines knowledge
- Source Document Review (SDR)
- Electronic Data Capture (EDC) familiarity
Single Sponsor CRA I (Must have UK on-site monitoring exp) Fully remote in London employer: Syneos Health
At Syneos Health, we pride ourselves on being an exceptional employer that prioritises the growth and development of our employees. With a strong commitment to career progression, comprehensive training, and a supportive work culture, we foster an inclusive environment where diverse perspectives are valued. Our remote monitoring role offers the unique advantage of flexibility while contributing to meaningful clinical research that impacts lives across the UK.
