Clinical Research Associate II

2 months ago


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

We are seeking a highly skilled Clinical Research Associate II to join our team at ICON Strategic Solutions. As a key member of our clinical operations team, you will be responsible for ensuring the smooth conduct of clinical studies at sites.

Key Responsibilities
  • Evaluate, initiate, monitor, and close out clinical study sites to ensure compliance with protocols, Good Clinical Practice regulations, and regulatory requirements.
  • Document all activities in clear, comprehensive, and accurate Monitoring Visit Reports, Contact Reports, and follow-up letters within required timelines.
  • Train and re-train site personnel on protocols, systems, and operational aspects of trials.
  • Serve as primary contact for site personnel and liaison between site personnel and sponsor study team members.
  • Develop patient recruitment strategies in conjunction with clinical sites to meet enrollment timelines.
  • Ensure subjects' rights, safety, and well-being are protected.
  • Ensure compliance with procedures for adverse events and serious adverse events.
  • Evaluate the quality and integrity of reported data and ensure timely resolution of queries.
  • Assist with data validation and cleaning procedures to ensure timely completion.
  • Identify, assess, and resolve site performance, quality, or compliance problems and develop intervention plans.
  • Communicate with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment, and overall site performance.
  • Maintain audit-ready clinical trial documentation and collect, review, monitor, and file required regulatory documentation.
Requirements

To be successful in this role, you will need:

  • Strong understanding of clinical trials and Good Clinical Practice regulations.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong problem-solving and analytical skills.
  • Ability to travel to clinical sites as required.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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