Clinical Research Associate, Sponsor Dedicated, Oncology or Immunology

Job Overview

Join our team as a Clinical Research Site Manager, where you’ll play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements.

Essential Functions

• 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.
• Training & Communication: Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
• 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. Support the start-up phase as required.
• 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.

Qualifications

• 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.

Pay

The potential base pay range for this role, when annualized, is $69,800.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

Schedule

You’ll work where the action is — out in the field, directly engaging with our customers, sites or partners. Field-based roles offer the opportunity to build relationships face-to-face, gain real-world insights and make a tangible impact.

IQVIA

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. Learn more at https://jobs.iqvia.com.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.