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Clinical Research Associate II

2 months ago


Indianapolis, Indiana, United States ICON Strategic Solutions Full time
About the Role

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 monitoring and managing clinical trials in the oncology space.

Key Responsibilities
  • Monitor and manage multiple oncology trials, with a focus on quality of life and regional travel.
  • Develop and implement site start-up documents, including SIV agendas, and provide training to site staff.
  • Act as a lead site manager, training and mentoring junior team members, and representing the team in meetings and discussions.
  • Provide input on study documents, including monitoring guidelines, and ensure compliance with Good Clinical Practice and ICH guidelines.
  • Support country budget development and contract negotiation, and assist with adverse event reporting.
  • Collaborate with investigators and site staff to meet study timelines and drive patient recruitment strategies.
Requirements
  • Minimum of 3 years' experience in monitoring pharmaceutical industry clinical trials, with a focus on oncology.
  • Strong analytical and risk-based monitoring skills, with experience in using various systems and databases.
  • Excellent communication and influencing skills, with the ability to work independently and as part of a team.
  • Ability to travel up to 50% and work in a fast-paced environment.
  • Knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.
What We Offer

At ICON, we offer a competitive salary and a range of benefits, including annual leave entitlements, health insurance, and retirement planning options. We also offer opportunities for professional development and growth, and a diverse and inclusive work environment.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you are interested in this role, please submit your application through our careers website.