Clinical Research Associate, Sponsor Dedicated, Oncology
IQVIA
Clinical Research Associate, Sponsor Dedicated, Oncology
Durham, United States of America | Field-based
Role Overview: As a Clinical Research Associate, you'll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be pivotal in advancing groundbreaking research.
Key Responsibilities:
- Site Visits: Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (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 escalate 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 Trial Master File (TMF) and Investigator's Site File (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.
Qualifications:
- 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.
Why Join Us? Be part of a team that's driving innovation in clinical research. Your contributions will help shape the future of healthcare. Apply now and embark on a rewarding career journey with us!
IQVIAVacancy posted 5 days ago
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