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Senior Clinical Research Associate II – UK
CTI Clinical Trial and Consulting Services. Serve as the main CTI contact for assigned study sites .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research activities, including site management, monitoring, and regulatory compliance. Proficient in ICH-GCP guidelines and capable of implementing effective subject enrollment strategies.
Highest-signal resume keywords
Clinical Research ExperienceICH-GCP KnowledgeSite Management ActivitiesRegulatory Document TrackingSubject Enrollment Strategies
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 InitiationInterim MonitoringClose-Out VisitsRegulatory RequirementsStudy Start-Up ActivitiesFeasibility AssessmentCRF RetrievalSource Document ReviewRemote MonitoringInvestigational Product Management
Soft Skills
CommunicationTeam CollaborationPresentation Skills
Industry Keywords
Clinical Trial ManagementEssential DocumentsMonitoring PlanSOPsProject Team Meetings
About the role
Key responsibilities & impact- Serve as the main CTI contact for assigned study sites
- Conduct pre-study, site initiation, interim monitoring, and close-out site visits
- Complete site visit deliverables according to the Monitoring Plan and required timelines
- Assist with or oversee study start-up, feasibility, pre-study activities, and site selection
- Collect, review, and track essential and regulatory documents
- Participate in required training and investigator, client, and project team meetings
- Create and implement subject enrollment strategies for assigned sites
- Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials
- Perform site management activities and provide site status updates to the Clinical Project Manager
- Conduct remote monitoring according to the study-specific Monitoring Plan
- Use systems and reports to track subject status, CRF retrieval/source document review, regulatory documents, and investigational product
- Assist with project-specific activities as a Project Team member
Requirements
What you’ll need- 3–5 years of clinical research experience as a CRA or related profession
- Life science background
- Excellent knowledge of ICH-GCP and regulatory requirements
- Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits
- Ability to complete site visit deliverables within required timelines
- Knowledge of applicable regulatory requirements, SOPs, and ICH GCP
- Ability to assist with or oversee study start-up activities, feasibility, pre-study activities, and site selection
- Ability to collect, review, and track essential/regulatory documents
- Ability to complete required general and study-specific training
- Ability to participate in investigator, client, and project team meetings, including presentations
- Ability to create and implement subject enrollment strategies
- Ability to manage investigational product and trial-related materials
- Ability to perform site management and remote monitoring activities
- Ability to use systems and reports to track subject status, CRF retrieval/source document review, regulatory documents, and investigational product
Benefits
Comp & perks- Structured mentoring program
- Leadership development courses
- Dedicated training department
- Ongoing education support
- Hybrid work opportunities
- CTI Cares community and global giving opportunities
- Work supporting the development of life-changing treatments