Senior Clinical Research Associate Norway Sponsor-Based
- Experience Level
- Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Sr Clinical Research Associate to work with one of the largest and most successful Pharmaceutical companies in the world. Employment would come from Syneos Health and you would be outsourced to this client.
- Demonstrate a commitment to quality in all aspects of monitoring and clinical research
- Monitor Investigative Sites’ adherence to GCP, ICH guidelines and local regulations, and Company policies
- Supervise the conduct of clinical studies, ensure compliance with protocols, regulatory requirements, and good clinical practice
- Build strong relationships with site personnel to ensure quality study conduct and patient safety
- Ensure subjects rights and safety are protected
- Conduct and document monitoring visits and CRO oversight visits
- Manage timely data entry and query resolution by investigative site
- Conduct timely onsite and remote Source Document Verification and Source Data Review
- Identify and mitigate issues, ensure timely escalation, and follow-up to resolution
- Review, maintain and reconcile Trial Master Files against Investigator Site Files
- Oversee Investigational Product documentation, storage, accountability and reconciliation at site
- Present and train during internal and external meetings
- Maintain trial management systems
- Effectively facilitate and negotiate contracts for assigned sites
- Provide county-specific expertise to ensure operational compliance with local regulations
- Work effectively with other departments and levels within the organization
- Mentor new CRAs as needed
The ideal candidate will need to following ezperience / skills to be considered:
- Minimum of BSc or Science degree in a helath related field with min. 3 years of clinical research experience.
- Previous proven experience in monitoring oncology studies.
- Demonstrated success in working independently.
- Strong communication and leadeship skills.
- Ability to work independently and travel up to 50 % of time.
- Fluent in local language and English.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
We have a comprehensive benefits package and offer highly competitive remuneration.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.