Clinical Research Associate

2 days ago

Oslo, Oslo County, Norway IQVIA Argentina Full time

About the Role

At IQVIA Argentina, we are seeking a highly skilled Clinical Research Associate to join our team. As a key member of our site management group, you will be responsible for ensuring that sites conduct studies and report data as required by the study protocol, applicable regulations, and sponsor requirements.

Main Responsibilities

  • Perform site monitoring visits to ensure adherence to contracted scope of work and Good Clinical Practice.
  • Work with sites to develop and track subject recruitment plans to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular communication lines to manage ongoing project expectations and issues.
  • Evaluate site practices related to the proper conduct of the protocol and adherence to applicable regulations, escalating quality issues as necessary.
  • Manage study progress by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution.
  • Ensure site documents are available for filing in the Trial Master File (TMF) and verify Investigator's Site File (ISF) compliance with GCP and local regulatory requirements.
  • Create and maintain documentation regarding site management, monitoring visit findings, and action plans through regular visit reports, follow-up letters, and other required study documentation.
  • Collaborate with study team members for project execution support as needed.
  • Develop and implement effective site financial management according to executed clinical trial agreements and retrieve invoices according to local requirements.

Requirements

  • Bachelor's Degree in a scientific discipline or healthcare preferred.
  • At least 2 years of on-site monitoring experience required.
  • Equivalent combination of education, training, and experience may be accepted in lieu of degree.
  • Good knowledge of and skill in applying clinical research regulatory requirements (GCP and ICH guidelines).
  • Strong therapeutic and protocol knowledge as provided in company training.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and use of laptop computer and iPhone/iPad (where applicable).
  • Excellent written and verbal communication skills, including good command of English language.
  • Organizational and problem-solving skills, effective time and financial management, and ability to establish and maintain effective working relationships.

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