Clinical Research Associate, Sponsor Dedicated, Oncology

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!