Location: Cork
Job Type: Permanent
Salary: €33,000 – €53,000/yr
About the job
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.
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