Oncology CRA: Sponsor-Driven Site Monitoring & Training

IQVIA LLC; Overland Park (KS); In loco; USD 90.000 - 198.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to ensure study sites operate efficiently and in full regulatory compliance. You will perform site visits, support patient recruitment efforts, and provide protocol training while maintaining strong site relationships and rigorous data management.

With oncology experience, you will monitor progress, ensure TMF/ISF quality, and collaborate with study teams to drive successful trial execution in a fast-paced environment.

Competenze

• Education: BS Degree in a scientific discipline or healthcare preferred.
• Experience: Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
• Knowledge: Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.
• Skills: Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.
• Attributes: Effective time and financial management, and the ability to build strong working relationships.

Mansioni

• Site Visits: Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with GCP and ICH guidelines.
• Recruitment Drive: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
• 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 elevate quality issues as needed.
• Study Progress: Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.
• Documentation: Maintain essential documents in the TMF and ISF as per regulatory requirements.
• Mentorship: Mentor clinical staff through co-monitoring and training visits.
• Collaboration: Work closely with study team members to support project execution.
• Financial Management: Manage site finances and retrieve invoices as per local requirements.

Conoscenze

Communication skills

Organizational skills

Problem-solving

Formazione

BS degree in a scientific discipline or healthcare

Strumenti

Microsoft Office

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to ensure study sites operate efficiently and in full regulatory compliance. You will perform site visits, support patient recruitment efforts, and provide protocol training while maintaining strong site relationships and rigorous data management.

With oncology experience, you will monitor progress, ensure TMF/ISF quality, and collaborate with study teams to drive successful trial execution in a fast-paced environment.