Clinical Research Associate

1 week ago


Parsippany, New Jersey, United States IQVIA Full time
Role Overview:

As a Clinical Research Associate, you will play a pivotal role in ensuring the smooth operation of our study sites. Your work will be instrumental in advancing groundbreaking research and contributing to the development of innovative medical treatments.

Key Responsibilities:
  • Conduct site visits to ensure compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
  • Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
  • Evaluate site practices for protocol adherence and escalate quality issues as needed.
  • Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.
  • Maintain essential documents in the Trial Master File (TMF) and Investigator's Site File (ISF) as per regulatory requirements.
  • Mentor clinical staff through co-monitoring and training visits.
  • Work closely with study team members to support project execution.
  • Manage site finances and retrieve invoices as per local requirements.
Qualifications:
  • BS Degree in a scientific discipline or healthcare preferred.
  • Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
  • Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.
  • Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.
  • Effective time and financial management, and the ability to build strong working relationships.
Why Work with Us:

At IQVIA, we are committed to driving innovation in clinical research and improving human health. Our team is dedicated to creating intelligent connections to accelerate the development and commercialization of innovative medical treatments. If you are passionate about making a difference in the lives of patients and contributing to the advancement of medical research, we encourage you to apply for this exciting opportunity.



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