Docs Global (Continental Europe)

Senior Clinical Research Associate

Location
Oslo, Norway
Salary
Competitive
Posted
24 Oct 2020
Closes
04 Nov 2020
Ref
24214
Hours
Full Time
Contract Type
Permanent
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 alison.burton@docsglobal.com for review and to arrange a call.