Job Title: Single Sponsor Clinical Research Associate II
Agency: Syneos Health
Location: United Kingdom
Salary/Rate: Not Specified

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Description

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely
• Evaluate site and site staff performance and recommend site-specific actions
• Escalate serious issues and develop action plans
• Verify informed consent, subject confidentiality, safety and clinical data integrity
• Assess site processes and conduct source document review
• Verify clinical data in case report forms and resolve queries
• 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, logs and project documents
• 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
• Liaise with study site personnel and collaborate with Central Monitoring Associates
• Train assigned sites and project-specific site team members
• Prepare for and attend Investigator Meetings, sponsor meetings, project meetings and clinical training
• Support audit readiness and audit follow-up actions
• For Real World Late Phase, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons and local country staff, train junior staff, identify out-of-scope activities and suggest potential sites

Requirements

• 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 30-40% regularly
• Must have UK monitoring experience
• Must be based in the UK
• Must comply with applicable site requests for medical and other personal information where required for facility access

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations, when appropriate, for employees or applicants with disabilities

How to Apply;

Interested and qualified candidates should:
Click here to apply online for this job

Disclaimer

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