Clinical Research Associate conducting site initiation, monitoring, and close - out visits for a biotech company advancing neuroscience therapies.
About the role
- Clinical Research Associate overseeing clinical trial sites and ensuring protocol compliance at Novo Nordisk. Collaborating with site staff to support innovative medicine development.
Responsibilities
- Serve as primary Novo Nordisk liaison to assigned clinical sites and cross‑functional study teams
- Conduct on‑site and remote monitoring visits per the Monitoring Plan, Protocol, ICH‑GCP, internal SOPs and applicable regulations
- Monitor patient safety and data integrity, manage queries and adverse event reporting, and resolve discrepancies in line with study requirements
- Track site performance, recruitment, retention and data delivery to meet timelines and quality objectives
- Manage IMP, study supplies, essential documents and site equipment accountability
- Provide site training and continuous operational support on protocol, systems and compliance requirements
- Maintain accurate trial documentation, including the Investigator Trial Master File, per the TMF plan
- Implement RBQM principles to identify, assess and mitigate risks throughout study conduct
- Support timely data cleaning in line with the Data Flow Plan
- Maintain inspection readiness and provide support during audits and inspections
- Ensure clinical activities are conducted to high quality standards in accordance with ICH‑GCP, regulations and internal SOPs
- Build strong relationships with site staff, investigators and key stakeholders
- Provide site feedback to inform protocol amendments, patient engagement initiatives and operational planning
Requirements
- Graduate in Medicine, Science, Pharmacy or other relevant
- Minimum 2 -4 years’ of experience working as a CRA
- Experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure
- Strong knowledge of ICH‑GCP, regulatory requirements and clinical trial methodology
- Proven track record delivering high‑quality clinical trial execution in compliance with ICH‑GCP, regulations and SOPs
- Excellent stakeholder management and communication skills
- Able to work independently and collaboratively in dynamic environments
- Strong organisational and time management skills; able to prioritise across multiple sites/studies
- Project management capabilities, attention to detail, integrity and commitment to patient safety
- Proficiency with EDC, CTMS, eTMF and other clinical systems
- Strong problem‑solving and proactive risk‑mitigation skills.
- Willingness to embrace new ways of working, continuous improvement and digital tools
- Flexibility to travel as required
Benefits
- Flexible travel required
- Opportunities for professional and personal development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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