Clinical Research Associate

3 weeks ago

San Diego, California, United States 5PY US Quintiles, Inc. Full time
Job Overview

As a Clinical Research Associate, you will play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements. Your expertise in site monitoring, recruitment management, and quality assurance will be essential in driving the success of our clinical trials.

Key Responsibilities
  • Site Monitoring: Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.
  • Quality Assurance: Evaluate site practices for protocol adherence and escalate quality issues as needed.
  • Study Progress: Track regulatory submissions, recruitment, enrollment, case report form (CRF) completion, and data query resolution.
  • Documentation: 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.
  • Mentorship: Mentor clinical staff through co-monitoring and training visits.
  • Collaboration: Work closely with study team members to support project execution.
Requirements
  • Education: BS Degree in a scientific discipline or healthcare preferred.
  • Experience: At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.
  • Knowledge: In-depth understanding of GCP and ICH guidelines.
  • Skills: Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.
  • Communication: Strong written and verbal communication skills with a good command of the English language.
  • Organization: Excellent organizational and problem-solving skills.
  • Management: Effective time and financial management abilities.
  • Interpersonal: Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

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