Clinical Research Associate

1 month ago

Oslo, Oslo County, Norway IQVIA Full time

Job Overview

As a Clinical Research Associate at IQVIA, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site management and monitoring visits 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.

Key Responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements.
  • Work with sites to adapt, drive and track subject recruitment plans to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.
  • Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications

  • High School Diploma or equivalent Degree in 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.
  • Good therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
  • Written and verbal communication skills - Must be fluent in English and Local language.
  • Organizational and problem-solving skills.
  • Effective time and financial management skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

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