Senior Clinical Research Associate

1 week ago


New York, New York, United States ICON Strategic Solutions Full time
Job Summary

We are seeking a highly skilled Senior Clinical Research Associate - Oncology to join our team at ICON Strategic Solutions. As a key member of our clinical operations team, you will be responsible for ensuring the integrity of clinical data and ensuring that studies are conducted in compliance with approved protocols, GCP, and applicable regulations.

Key Responsibilities
  • Monitoring Activities: Conduct onsite and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
  • Site Qualification: Qualify potential investigative sites and ensure they are equipped to conduct clinical trials.
  • Data Integrity: Verify the protection of study participants and ensure that informed consent procedures and protocol have been performed in accordance with applicable regulations.
  • Site Management: Manage investigative site staff to facilitate trial deliverables, such as subject enrollment and data deliverables.
  • Investigational Product Management: Verify proper management and accountability of Investigational Product (IP).
  • Reporting: Write and submit reports of investigational site findings and updates applicable tracking systems.
  • Audit Preparation: Participate in audit preparation and follow-up activities as needed.
  • Key Risk Assessment: Perform key risk assessment and management responsibilities throughout the project.
Requirements
  • 2-3 years of Oncology monitoring experience.
  • Strong knowledge of ICH-GCP guidelines, applicable regulations, and SOPs.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.



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