Description
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:
- Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
- Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
- Evaluate site practices for protocol adherence and escalate quality issues as needed.
- Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.
- Maintain essential documents in the Trial Master File (TMF) and Investigator's Site File (ISF) as per regulatory requirements.
- Mentor clinical staff through co-monitoring and training visits.
- Work closely with study team members to support project execution.
- Manage site finances and retrieve invoices as per local requirements.
Qualifications:
- BS Degree in a scientific discipline or healthcare preferred.
- Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.
- Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.
- Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.
- Effective time and financial management, and the ability to build strong working relationships.
The potential base pay range for this role, when annualized, is $90,200.00 - $197,500.00.