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Senior Clinical Research Associate

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Primary Location: Xzagreb, Croatia Full time R1340931

Job description

Senior Clinical Research Associate, Sponsor dedicated

-Based in Croatia-

Why should you apply?

  • When you join IQVIA as a sponsor dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers
  • With us, you don´t have to jump from one company to another to build a career. We strongly support our employee´s career development, and we create long-term plans.
  • IQVIA has been nominated a top 500 company every year since our inception in 2016
  • You will become a member of 75.000+ brave minds who are passionately working together on advancing human health
  • We offer attractive compensation package, better work-life balance, attractive sponsors and projects, and supportive management

Job Overview:

  • By performing monitoring and site management work in accordance with contracted scope of work and regulatory requirements, you will ensure that sites are conducting the studies as required by the study protocol, applicable regulations and guidelines, and sponsor´s requirements.

Your tasks will include:

  • Site monitoring visits - selection, initiation, monitoring, and close-out visits
  • Working with sites to adapt, drive, and track subject recruitment plan
  • Administering protocol and related study training to assigned sites and establishing regular lines of communication with them
  • Evaluating the quality and integrity of study site practices and escalating quality issues as appropriate
  • Managing the study progress by tracking regulatory submissions and approvals, recruitment and enrolment, case report form completion and submission, and data query generation and resolution. May support start-up phase.
  • Ensuring site documents are available for filing in the Trial Master File and verify that the Investigator's Site File is maintained in accordance with Good Clinical Practice and local regulatory requirements.
  • Creation and maintenance of appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Collaboration with study team members for project execution support

Qualifications:

  • Degree in scientific discipline or health care preferred
  • At least 2 years of on-site monitoring experience
  • Good knowledge of clinical research regulatory requirements
  • Desire to learn and implement therapeutic and protocol knowledge as provided in company training
  • Computer skills
  • Excellent Knowledge of both Croatian and English language
  • Organizational and problem-solving skills
  • Effective time and financial management skills
  • Flexibility to travel; active driver with a valid driver´s license
  • Ability to establish and maintain effective working relationships with co-workers, managers, and clients

#LI-ZELJKASEGRC#LI-Hybrid

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. Learn more at https://jobs.iqvia.com

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