Science, Pharmaceutical & Food
Clinical Trial Associate
- Full Time
PE Global is currently recruiting Clinical Trial Associates on behalf of a leading multinational company in Cork.
The Clinical Trial Associate will ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout. The Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management and site training.
Responsibilities include but are not limited to:
- Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents.
- Communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, 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
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Populate internal systems to ensure accuracy of trial / site performance
- Populate Trial Master Files and libraries for future reference
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File.
- Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience
- Understanding of the overall clinical development paradigm and the importance of efficient site initiation
- Fluency in English PLUS one of the following languages: Polish, Romanian, Dutch, French, Flemish or German is essential.
- Applied knowledge of project management processes and skills
- Experience in compliance-driven environment
Interested candidates should forward an up to date CV to email@example.com or call me on 021 4297900.