Single Sponsor CRA I/II – UK Monitoring Experience
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Job Description
Clinical Research Associate monitoring UK clinical trial sites for Syneos Health, a life sciences services organization. Ensuring GCP compliance, data integrity, site performance and audit readiness.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely
- Ensure regulatory, ICH-GCP/GPP and protocol compliance
- Evaluate site and site staff performance and provide recommendations and action plans
- Verify informed consent, subject safety, confidentiality and clinical data integrity
- Conduct source document review and verify case report form data accuracy and completeness
- Resolve queries remotely and on site and guide site staff
- Verify electronic data capture compliance
- Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities through required letters, reports and communication logs
- Support subject/patient recruitment, retention and awareness strategies
- Track observations, site status and action items to resolution
- Manage site-level activities and communications to meet project objectives, deliverables and timelines
- Act as liaison with study site personnel and ensure site/project team training and compliance
- Attend investigator, sponsor, global monitoring and clinical training meetings
- Support audit readiness and audit follow-up actions
- For real-world late phase studies, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and suggest potential sites based on local knowledge
Requirements:
- Must have UK monitoring experience
- 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 ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Opportunity to collaborate with colleagues from across the world
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