Single Sponsor Senior Clinical Research Associate (UK monitoring experience needed)
Role Overview
Single Sponsor Senior Clinical Research Associate role requiring UK monitoring experience.
The clinical solutions team works with customers across drug development and commercialization.
Key Skills for This Role
Full Job Posting
Role overview
Single Sponsor Senior Clinical Research Associate role requiring UK monitoring experience.
The clinical solutions team works with customers across drug development and commercialization.
Clinical monitoring and site management
- Conduct site qualification, initiation, interim monitoring, site management, and close-out visits remotely or on site.
- Assess site and staff performance, ensure regulatory, ICH/GCP and/or GPP, and protocol compliance, and escalate serious issues.
- Verify informed consent documentation and confidentiality; assess participant safety, protocol deviations, and pharmacovigilance issues.
- Review source documents and medical records, verify CRF data, resolve queries, and confirm electronic data capture compliance.
- Where applicable, reconcile investigational product inventory and verify storage, dispensing, administration, and handling.
- Review and reconcile the Investigator Site File and Trial Master File, and support essential document archiving.
- Document visits and communications, track action items, and support participant recruitment and retention.
Experience and knowledge
- UK monitoring experience is specified in the job title.
- Maintain working knowledge of ICH/GCP guidance or other applicable guidance, relevant regulations, and company SOPs and processes.
About Syneos Health
Syneos Health describes itself as an integrated life sciences services organization supporting drug development and commercialization.
The company describes opportunities for career development, training, and collaboration across clinical solutions teams.
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