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Study Start-Up Clinical Research Associate

  1. United States
2023-102595
  1. Clinical Monitoring
  2. ICON Strategic Solutions
  3. Remote

About the role

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As a Study Start-Up Clinical Trial Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.


What you will be doing:

  • Supports country SSU strategy in close collaboration with Study Start-Up Team Lead,
    Study Start-Up Manager, Feasibility Manager as well as Site Partnership Manager
  • Collaborates with Study Start-Up Manager, Study Start-Up Team Lead and global study
    team to ensure Study Start-Up timelines and deliverables are met according to country
    commitments
  • Accountable for timely start-up activities from country allocation until site greenlight at assigned
    sites
  • Conducts site selection visits, verifies site eligibility for a specific study
  • Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission
    preparation
  • Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
  • Facilitates the preparation and collection of site and country level document
  • Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all
    relevant site personnel within agreed timelines
  • Negotiates investigator payments as needed
  • Supports preparation of audits and inspections as applicable
  • Supports reduction of formal site-specific IRB/IEC deficiencies
  • Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to
    ensure TMF inspection readiness

You are:

  • Bachelor's Degree in Scientific field or RN with equivalent experience
  • Experienced with at least 2 years of study start up monitoring experience in CRO or Pharmaceutical industry
  • Willing to travel at least 50% regionally in the United States for site selection visits
  • Passionate about building relationships at the site level and driving site and account development 
  • Able to work across multiple therapeutic areas



Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also 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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? 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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