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Clinical Research Associate II, UK Monitoring Experience
Syneos Health. Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site management, monitoring, and compliance with Good Clinical Practice/ICH Guidelines, while effectively managing site-level activities and communications. Proficient in clinical data verification, subject recruitment strategies, and maintaining audit readiness.
Highest-signal resume keywords
UK Monitoring ExperienceGood Clinical Practice/ICH Guidelines KnowledgeClinical Data VerificationSite ManagementExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site QualificationSite InitiationSource Document ReviewElectronic Data Capture ComplianceInvestigational Product Inventory ManagementClinical Data Accuracy VerificationMonitoring Activity DocumentationChart AbstractionData CollectionAction Plan Development
Soft Skills
Interpersonal SkillsPresentation SkillsProblem-Solving Skills
Tools & Technologies
Tracking SystemsTrial Master FilesElectronic Data Capture Systems
Certifications & Qualifications
Bachelor’s DegreeRegistered Nurse (RN) or Equivalent
Industry Keywords
Clinical StudySite ManagementPatient RecruitmentAudit ReadinessRegulatory Compliance
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely
- Evaluate site and site staff performance and provide recommendations and action plans
- Verify informed consent, subject confidentiality, safety and clinical data integrity
- Assess site processes and conduct source document review
- Verify clinical data accuracy and completeness in case report forms
- Resolve queries remotely and on site within agreed timelines
- Support clinical study data review and capture and verify electronic data capture compliance
- Perform investigational product inventory, reconciliation and storage reviews as needed
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities and maintain tracking systems
- Support subject/patient recruitment, retention and awareness strategies
- Manage site-level activities, communications, deliverables and timelines
- Liaise with study site personnel and ensure site/project team training and compliance
- Attend investigator, sponsor, 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 as requested, and identify out-of-scope activities and potential sites
Requirements
What you’ll need- 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
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Remote work arrangement (Remote (Pre-Approved))