Description
If you're passionate about clinical research and thrive in a site-facing role, this is an opportunity to contribute to the successful execution of clinical studies while ensuring the highest standards of quality and compliance.
As a Senior Clinical Research Associate I, you will perform monitoring and site management activities to ensure sites conduct studies and report data in accordance with study protocols, applicable regulations and guidelines, and sponsor requirements.
Key Responsibilities
- Perform site monitoring visits in accordance with contracted scope of work and Good Clinical Practice (GCP)
- Work with sites to adapt, drive, and track subject recruitment plans in line with project needs
- Administer protocol and study-related training to assigned sites and maintain regular communication with site personnel
- Evaluate the quality and integrity of study site practices and ensure adherence to study protocols and applicable regulations
- Escalate quality issues as appropriate
- Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution
- Support start-up activities where applicable
- Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained according to GCP and local regulatory requirements
- Create and maintain monitoring documentation, visit reports, follow-up letters, and action plans
- Collaborate with study team members to support project execution
- Support subject recruitment planning on a site level where applicable
- Support site financial management activities where applicable
Requirements
- Bachelor's degree in a scientific discipline or healthcare field preferred
- Minimum 2 years of on-site monitoring experience
- Equivalent combination of education, training, and experience may be considered
- Good knowledge of applicable clinical research regulations, including ICH-GCP guidelines
- Good therapeutic and protocol knowledge
- Proficiency with Microsoft Word, Excel, PowerPoint, and other relevant technology tools
- Strong written and verbal communication skills, including a good command of English
- Strong organisational, problem-solving, time management, and financial management skills
- Ability to build and maintain effective working relationships with colleagues, managers, clients, and site personnel