Experienced Clinical Research Associate SM

1 dzień temu


Warszawa, Mazovia, Polska TN Poland Pełny etat

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Experienced Clinical Research Associate SM, WarsawClient:

IQVIA

Location:

Warsaw, Poland

Job Category:

Other

EU work permit required:

Yes

Job Reference:

23dbfc09693d

Job Views:

2

Posted:

17.03.2025

Expiry Date:

01.05.2025

Job Description:

Our team is growing, join us on our mission to drive healthcare forward

What We Offer / USPs
  • The chance to work on cutting edge medicines at the forefront of new medicines development.
  • IQVIA has access to significant data pools allowing better site selection and recruitment, driving performance of sites and making the CRA role more efficient.
  • Genuine career development opportunities for those who want to grow as part of the organization.
  • Flexibility regarding site locations to minimize travel; consideration for candidates looking for a 4-day working week.
  • As a CRA, you will receive an iPad and use key developments such as site visit apps that allow CRAs to perform their duties more efficiently.
Responsibilities
  • Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Work with sites to adapt, drive, and track subject recruitment plans in line with project needs.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.
  • 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 site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained according to GCP and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management and monitoring visit findings.
  • Collaborate and liaise with study team members for project execution support.
  • If applicable, may be accountable for supporting development of project subject recruitment plans on a per site basis.
  • If applicable, may be accountable for site financial management according to executed clinical trial agreements.
Requirements
  • Life science degree education.
  • Experience of independent on-site monitoring.
  • Experience handling multiple protocols and sites across a variety of drug indications.
  • Flexibility and ability to travel.
  • Strong communication, written, and presentation skills.
Awards
  • FORTUNE Magazine's World's Most Admired Companies list for the third year in a row - Ranked #1 in Its Category for the Second Consecutive Year.
  • Best AI-based Solution for Healthcare Award in 2023 Artificial Intelligence Breakthrough Awards.

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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