Senior Clinical Research Associate

hace 1 mes

Málaga, Málaga, España Pharmiweb A tiempo completo

Job Summary:

As a Senior Clinical Research Associate, you will be responsible for coordinating all aspects of clinical monitoring and site management processes in accordance with regulatory guidelines, local regulations, and standard operating procedures.

You will be a key decision-maker, solving problems independently or as part of the client and ICON team. Your role will involve managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and motivating the team to achieve high-quality results.

Key Responsibilities:

  • Monitor multiple Phase I, II, III, and IV clinical trial sites across different therapeutic areas.
  • Assist other CRAs with co-monitoring activities, both remote and on-site.
  • Utilize your customer service mindset to deliver value, build loyalty, and trust with investigators and study coordinators.
  • Collaborate with the team to develop commitment to study timelines and objectives through regular visits with site staff.
  • Ensure patient safety and data integrity by reviewing source to CRF/eCRF.
  • Escalate concerns/issues to other departments, including Safety, Investigational Medicinal Product, Local Study Managers, and management team as appropriate.

Requirements:

  • Bachelor's Degree (or equivalent) with 2-4 years of relevant healthcare experience in the pharma or clinical research industry.
  • Minimum 3 years of monitoring and site management experience.
  • Strong experience in phase 1 trials.
  • Scientific background.
  • Proficiency with medical terminology.
  • Working knowledge of Local Regulations.
  • Demonstrated working knowledge of ICH/GCP Guidelines.
  • Excellent record-keeping skills and attention to detail.
  • Experience conducting Site Selection, Initiation, Routine Monitoring, and Close Out Visits both remotely and on-site.
  • Fluent in English, both written and oral.
  • Strong technical skills with CTMS, eCRF, eTMF.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises an excellent level of base pay, as well as a wide range of variable pay and recognition programs.

In addition, our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.

Our success depends on the knowledge, capabilities, and quality of our people.

That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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