Clinical Research Associate, Sponsor Dedicated, Oncology or Immunology

4 weeks ago

San Diego, California, United States IQVIA, Inc. Full time
Job Overview

As a Clinical Research Site Manager, you will play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements. Your responsibilities will include site monitoring, recruitment management, training and communication, quality assurance, study progress tracking, documentation, mentorship, and collaboration with the study team.

Key Responsibilities
  • Conduct site monitoring visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.
  • 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, case report form (CRF) completion, and data query resolution.
  • Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) according to GCP/ICH and local regulations.
  • Mentor clinical staff through co-monitoring and training visits.
  • Work closely with study team members to support project execution.
Requirements
  • BS Degree in a scientific discipline or healthcare preferred.
  • At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.
  • In-depth understanding of GCP and ICH guidelines.
  • Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.
  • Strong written and verbal communication skills with a good command of the English language.
  • Excellent organizational and problem-solving skills.
  • Effective time and financial management abilities.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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