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Junior Clinical Research Associate
Novo Nordisk. Oversee assigned clinical trial sites through on-site and remote monitoring with risk-based quality management (RBQM) .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in overseeing clinical trial sites with a focus on risk-based quality management, ensuring compliance with ICH-GCP and regulatory requirements, and maintaining participant safety and data integrity. Proficient in managing clinical trial systems and fostering strong relationships with site staff and study teams.
Highest-signal resume keywords
Clinical Trial MonitoringICH-GCP ComplianceElectronic Data Capture (EDC)Time ManagementProblem-Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial MethodologyRegulatory RequirementsData CleaningSite Performance TrackingAdverse Event Management
Soft Skills
Clear CommunicationAttention to DetailOrganizational SkillsRelationship BuildingProactivity
Tools & Technologies
Clinical Trial Management System (CTMS)Electronic Trial Master File (eTMF)
Certifications & Qualifications
GCP Qualification
Industry Keywords
Life SciencesClinical ResearchRisk-Based Quality Management (RBQM)Investigator Trial Master FileSite Training
About the role
Key responsibilities & impact- Oversee assigned clinical trial sites through on-site and remote monitoring with risk-based quality management (RBQM)
- Act as the main point of contact between Novo, clinical sites and the study team
- Conduct on-site and remote visits according to the Monitoring Plan, Protocol, ICH-GCP, SOPs and local regulations
- Protect participant safety and data integrity by reviewing site data, resolving discrepancies and managing adverse events
- Ensure data cleaning timelines are met
- Track recruitment, retention, data collection and site performance against study timelines, quality objectives and clinical operations KPIs
- Train and support site staff on protocols, procedures and systems
- Manage investigational product, study supplies, equipment and essential documents, including the Investigator Trial Master File
- Keep trials inspection-ready and support audits and inspections
- Resolve or escalate site issues early
- Share site feedback and practical improvement ideas
- Support fellow CRAs through knowledge sharing
- Report to the Clinical Operations Manager
- Participate in investigator meetings, CRA training sessions and local and global trial meetings
Requirements
What you’ll need- A bachelor’s degree in Life Sciences or a related field
- A basic GCP qualification
- At least 2 years’ experience in industry-sponsored clinical research or up to 1 year of experience as a CRA
- Solid knowledge of ICH-GCP, regulatory requirements and clinical trial methodology
- Confidence using clinical trial systems such as electronic data capture (EDC), CTMS and eTMF
- Strong organisation and time management skills
- Attention to detail to manage several sites and priorities at once
- Clear written and verbal communication
- Ability to build trusted relationships with site staff and colleagues at all levels
- Proactive, problem-solving approach
- Flexibility to travel as required
Benefits
Comp & perks- On-the-job growth and monitoring expertise development
- Learning from experienced CRAs, manager and wider trial team
- CRA training
- International study meetings
- Investigator meetings
- Inclusive recruitment process and equality of opportunity