Clinical Research Associate II - Late Phase
Madrid, ES
hace 6 días

Descripción del trabajo

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

IQVIA- Real World Evidence Solutions has exciting permanent career opportunities on offer for experienced CRAs (office-based in Madrid / Barcelona or home-based in different locations)

Within IQVIA, the Real World Evidence business unit employs over 1,000 dedicated staff to design, implement and manage real-world and post-marketing studies.

As healthcare stakeholders increasingly need evidence to support regulatory, reimbursement and prescribing decisions, the IQVIA RWE team offers a comprehensive evidence approach to meet our customer’s unique needs for demonstrating safety, effectiveness and quality.

  • Perform site selection, start-up / regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
  • 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 to international Clinical Project Manager (CPM), Site Management Lead (SML) and / or line manager.

  • Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.
  • Required Knowledge, Skills and Abilities

  • Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Strong written and verbal communication skills in Portuguese & English
  • Good organizational, interpersonal and problem-solving skills
  • Strong attention to detail
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
  • Availability to travel
  • Minimum Required Education and Experience

    Bachelor’s Degree preferably in life science and minimum of 2 years of independent monitoring experience in Late Phase or Interventional studies.

    What We Can Offer You

    At IQVIA you have the opportunity to make a lasting impact on our customers, the industry, patient health around the world, and your career.

    We are committed to rewarding your contributions with a combination of competitive salaries, comprehensive benefits, and an award winning culture.

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