The purpose of the Trial Capabilities Associate role for a company based in Cork, Ireland who is looking to grow their career in Clinical Trials.
*Native Romanian speaker with fluency in English is essential for this role.*
Responsibilities
- Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA) (where applicable), track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
- Identify, communicate, and resolve issues
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Leverage previous site / review board engagements to efficiently drive new work
- Populate internal systems to ensure accuracy of trial / site performance
- Understand and comply with procurements, legal and financial requirements and procedures
- Populate Trial Master Files and libraries for future reference
- Provide feedback and shared learning for continuous improvement
- Leverage trial prioritization
- Anticipate and monitor dynamically changing priorities
Qualification Requirements:
- Bachelor's degree preferably in a scientific or health related field
- One year experience working in clinical trials
- Understanding of the overall clinical development paradigm and the importance of efficient site activation
- Applied knowledge of project management processes and skills
- Appreciation of / experience in compliance-driven environment
- Effective communication, negotiation, and problem solving skills
- Self-management and organizational skills
- Native Romanian speaker with fluency in English is essential for this role.
Additional Preferences:
- Two years clinical research experience or relevant experience preferred
