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Job description
Clinical Research Associate
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.
Worksite address
durham, NC, 27703, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.