Senior Oncology Clinical Research Associate

2 days ago


Reston, Virginia, United States ICON Strategic Solutions Full time
Job Summary

We are seeking a highly skilled Senior Oncology Clinical Research Associate to join our team at ICON Strategic Solutions. As a key member of our clinical trials team, you will be responsible for monitoring and managing oncology trials, ensuring the highest level of quality and compliance.

Key Responsibilities
  • Monitor and manage multiple oncology trials, ensuring timely and accurate data collection and reporting.
  • Develop and implement quality control measures to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
  • Collaborate with cross-functional teams, including investigators, site staff, and central study teams, to ensure seamless trial execution.
  • Provide training and support to junior team members, promoting knowledge sharing and skill development.
  • Develop and maintain site start-up documents, including SIV agendas, to ensure efficient trial initiation.
  • Review and provide feedback on study documents, including Monitoring Guidelines, to ensure accuracy and compliance.
  • Represent the team at Local Trial Management (LTM) meetings and Site Management Teams (SMTs), ensuring effective communication and collaboration.
  • Take ownership of LTM role reports, reviewing and analyzing data to ensure quality and compliance.
  • Support country budget development and contract negotiation, working closely with CCS colleagues.
  • Assist with Adverse Event (AE) reporting and metrics/KPIs, ensuring timely and accurate data collection and analysis.
Requirements
  • Minimum of 3 years' experience in monitoring pharmaceutical industry clinical trials, with a focus on oncology.
  • Strong analytical and problem-solving skills, with the ability to drive patient recruitment strategies and manage study timelines.
  • Excellent communication and influencing skills, with the ability to work effectively with investigators, site staff, and cross-functional teams.
  • Knowledge of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.
  • Ability to travel up to 50% of the time, with a preference for candidates based in the New York area.
What We Offer

At ICON Strategic Solutions, we offer a competitive salary and a range of benefits, including annual leave entitlements, health insurance, retirement planning, and a global Employee Assistance Programme. We are committed to diversity, inclusion, and belonging, and we welcome applications from candidates from diverse backgrounds.



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