Docs Global (Continental Europe)

Senior Clinical Research Associate

Oslo, Norway
24 Oct 2020
04 Nov 2020
Full Time
Contract Type
Experience Level
Experienced (non-manager)
In this role you will contribute to identifying new sites for clinical trial with full responsibility for clinical site management. Duties will include;

• SIVs and training, generate initiation visit report.
• Monitoring visits, regulatory assessment, drug supply management and ensure compliance with protocol, GCP, global and local regulations, global and local processes.
• Identify, manage and resolve issues and escalate as appropriate.
• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
• Prepare and complete monitoring reports
• Data review; resolve technical and content issues to achieve timely database lock targets.
• Follow-up to ensure resolution of issues
• Manage site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection

Minimum Requirements:

• 5 years' experience monitoring global trials and Bachelor's or RN level degree is required. Degree in life sciences, pharmacy preferred.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus.
• Proven ability to work independently in a fast-paced environment.
• Strong communication, interpersonal, and organizational skills.
• Must demonstrate good computer skills.
• Ability to travel as necessary up to 50% depending on assignment. Overnight and occasional weekend travel may be required.

If you are open to a great opportunity to further develop your CRA experience, please send your CV to for review and to arrange a call.