Clinical Research Associate Specialist

2 days ago

Oslo, Oslo County, Norway IQVIA Full time

Job Overview
IQVIA seeks a Clinical Research Associate to perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Responsibilities
• Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with contracted scope of work and regulatory requirements.
• Collaborate with sites to develop and implement subject recruitment plans to enhance predictability and meet project needs.
• Provide protocol and study training to assigned sites and maintain regular communication to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the protocol and adherence to applicable regulations, escalating quality issues as necessary.
• Track and manage study progress, including regulatory submissions, case report form completion, and data query resolution.
• Maintain accurate documentation of site management, monitoring visit findings, and action plans, submitting regular visit reports and generating follow-up letters as required.

Qualifications
• High School Diploma or equivalent degree in a scientific discipline or health care preferred.
• Equivalent combination of education, training, and experience may be accepted in lieu of degree.
• Basic knowledge of and skill in applying applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Proficiency in Microsoft Word, Excel, and PowerPoint, as well as use of a laptop computer and mobile devices.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We strive to make a positive impact by pushing the boundaries of human science and data science. Learn more at IQVIA.com.

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