CRA II

QPL IQVIA RDS Poland Sp. z o.o.

Manchester

On-site

GBP 38,000 - 52,000

Full time

3 days ago
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Job summary

IQVIA is actively seeking experienced Clinical Research Associates to join our Site Management team. You will perform site monitoring visits, ensure adherence to GCP/ICH guidelines, and support project execution across multiple sponsor studies.

Join a global leader committed to integrity and career development. You will gain exposure to diverse interventional studies, collaborate with sites, and grow within IQVIA's expanding clinical research services.

Qualifications

  • Requires at least 2 years on-site monitoring experience of interventional studies.
  • Degree in scientific discipline or healthcare or equivalent industry experience.
  • Good knowledge of GCP and ICH guidelines and regulatory requirements.
  • Ability to establish and maintain effective working relationships with coworkers and clients.

Responsibilities

  • Perform site monitoring visits in accordance with GCP/ICH and contracted scope.
  • Drive subject recruitment plan to enhance predictability.
  • Administer protocol training to assigned sites and maintain regular communication with sites.
  • Evaluate the quality and integrity of site practices and adherence to regulations.
  • Escalate quality issues as appropriate.
  • Track regulatory submissions, recruitment, CRF completion and data query resolution.
  • May support start-up phase.
  • Ensure TMF/ISF documentation is filed and maintained.
  • Collaborate with study team for project execution support.

Skills

On-site monitoring experience
Regulatory knowledge
Stakeholder communication

Education

Degree in scientific discipline or healthcare

Job description

Join IQVIA on our mission to accelerate innovation for a healthier world! IQVIA's Site Management (full service / multi-sponsor) team is growing and seeking experienced Clinical Research Associates.

Why IQVIA?

Genuine career development opportunities to grow as we grow AI-powered career advancement through our internal talent marketplace, Career Connections Mentorship opportunities across the organisation via Employee Resource Groups Flexible working to assist work-life balance and professional success Well‑being support covering your physical, mental, and financial health Awards 2026 "Glassdoor Best Place to Work in the UK" #1 in category - 2026 Fortune® World's Most Admired Companies™ list (for the FIFTH consecutive year!) Brandon Hall Excellence Award for Learning & Development

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 plan in line with project needs 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.
  • Escalate quality issues as appropriate
  • 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.
  • May support start-up phase
  • 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 and local regulatory requirements
  • Create and maintain 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
  • Collaborate and liaise with study team members for project execution support as appropriate
Requirements
  • Requires at least 2 years on-site monitoring experience of interventional studies
  • Degree in scientific discipline or health care or equivalent industry experience
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Ability to establish and maintain effective working relationships with coworkers and clients

Please note - this position is not eligible for visa sponsorship

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.

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