Clinical Research Associate II

4 weeks ago

Tennessee, United States ICON Strategic Solutions Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our Oncology team. As a key member of our team, you will be responsible for working on multiple oncology trials, with a focus on quality of life and regional travel.

Key Responsibilities
  • Work on multiple oncology trials, with a focus on quality of life and regional travel.
  • Develop and implement site start-up documents, including SIV agendas.
  • Provide SM "voice" when reviewing study documents, such as Monitoring Guidelines.
  • Represent LTMs or SMs on SMTs/meetings.
  • Take over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial.
  • Support country budget development and/or contract negotiation in liaison with CCS colleagues.
  • Assist with ASV.
  • Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces
  • Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
  • Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
Requirements
  • Based in the Tennessee (near a major airport).
  • Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences.
  • Have a minimum of 3 years' experience in monitoring pharmaceutical industry clinical trials.
  • Have a minimum of 1-3 years' experience monitoring Oncology trials.
  • Knowledge of several therapeutic areas, with oncology an asset but not a requirement.
  • Analytical/risk-based monitoring experience is an asset.
  • Ability to actively drive patient recruitment strategies at assigned sites.
  • Ability to partner closely with investigator and site staff to meet all of our study timelines.
  • Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
  • Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face.
  • Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
  • Need to travel up to 50%.
What ICON Can Offer You

We are committed to building a diverse culture that rewards high performance and nurtures talent. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

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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