Clinical Research Associate, Sponsor Dedicated, Oncology or Immunology
$69,800–$226,800 year
On-siteDurham, North Carolina, United States
Job Summary
Conduct selection, initiation, monitoring, and close-out 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 while evaluating site practices for protocol adherence and escalating quality issues. Provide protocol training, maintain regular communication to manage expectations, and mentor clinical staff through co-monitoring and training visits. Track regulatory submissions, recruitment, enrollment, case report form completion, and data query resolution, ensuring all site documents are filed in the Trial Master File and Investigator's Site File. Work closely with study team members to support project execution, with a typical travel expectation of 6-10 days per month. This role supports IQVIA's mission to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes worldwide.
Required Qualifications
- BS Degree in a scientific discipline or healthcare
- At least 2.5 years of on-site monitoring experience
- In-depth understanding of GCP and ICH guidelines
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Adept at using laptops, iPhones, and iPads
- Strong written and verbal communication skills
- 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
- 6-10 DoS per month typical expectation
Desired Qualifications
- Preference for oncology or immunology
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