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Clinical Research Associate II (CRA2)

iqvia · Porto Salvo

Novo
Mid 🇬🇧 English
GCP ICH guidelines

Descrição do cargo

About the role

IQVIA is recruiting a Clinical Research Associate II (CRA2) within its Clinical Functional Service Partnership (CFSP) model. The role applies clinical research expertise to drive outcomes for patients and sponsors, working on innovative studies across a variety of therapeutic areas. The CFSP model combines the variety and sponsor-level exposure of being an embedded member of a pharmaceutical or biotechnology team with the stability and career support of IQVIA.

Key responsibilities

  • Conduct site qualification, initiation, monitoring and close-out visits according to study protocols, GCP, ICH guidelines and regulatory requirements.
  • Ensure sites maintain high standards of patient safety, data integrity, protocol compliance and study quality.
  • Build and maintain relationships with investigators and site personnel, providing guidance, training and support.
  • Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution and site performance metrics.
  • Collaborate with sites on patient recruitment and retention strategies.
  • Maintain accurate, inspection-ready documentation such as Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports and follow-up communications.
  • Identify and escalate study risks, site issues and quality concerns, and partner with cross-functional teams on study execution.
  • Mentor junior team members through coaching, training and co-monitoring, and contribute to continuous improvement and site financial activities.

Required profile

  • University degree in Life Sciences, Health Sciences, Nursing, Pharmacy or a related discipline, or equivalent education and experience.
  • 2-4 years of on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology or healthcare environment.
  • Preferrable: experience in a sponsor-dedicated or cFSP environment, and knowledge of patient recruitment and study start-up.
  • Fluent written and spoken local language (minimum C1) and strong command of English.
  • Willingness to travel up to 40-60% of working time within the assigned region, and a valid Class B driver's licence.

Required skills

  • Strong knowledge of GCP, ICH guidelines and applicable regulatory requirements.
  • Excellent communication, organisational and stakeholder management skills.
  • Ability to work independently, manage multiple priorities and collaborate in cross-functional teams.

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Source : ats:workday

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Porto Salvo