Clinical Research Associate II

2 days ago

Indianapolis, Indiana, 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 managing clinical trials, ensuring compliance with regulatory requirements, and providing exceptional support to our investigators and site staff.

Key Responsibilities
  • Manage multiple oncology trials, focusing on quality of life and regional travel
  • Develop and implement site startup documents, including SIV agendas
  • Provide subject matter expertise on study documents, such as Monitoring Guidelines
  • Represent LTMs or SMs on SMTs and meetings
  • Take over LTM role reports review for sites assigned to other SMs from the same trial
  • Support country budget development and contract negotiation with CCS colleagues
  • Assist with ASV and metrics/KPIs 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 Indiana (near a major airport)
  • Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
  • Minimum of 3 years' experience in monitoring pharmaceutical industry clinical trials
  • 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 We Offer

We offer a competitive salary, a range of benefits, and opportunities for professional growth and development. Our benefits include various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and a Global Employee Assistance Programme.

We are committed to diversity, inclusion, and belonging, and we strive to create a workplace that is free of discrimination and harassment. We welcome applications from qualified candidates who share our values and are passionate about delivering exceptional results.

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