Clinical Research Associate, Sponsor Dedicated, Oncology or Immunology

IQVIA • Durham, NC

2d

About The Position

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. Travel: 6-10 DoS per month typical expectation, can be exceptions given the nature of the position. 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 IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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.

Nice To Haves

• Experience: At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees