Our Cork city-based biotech client is kicking off a major new recruitment project which will require the hiring of 100+ in-house Clinical Trials experts over 12 months. A superb office and team environment along with salary and benefits package will reward successful candidates here.
The Clinical Trial Team provides clinical trial capabilities in support of clinical development. The Associate is accountable to 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.
The Associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File.
• 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), 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
• 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
Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
Understanding of the overall clinical development paradigm and the importance of efficient site initiation
Applied knowledge of project management processes and skills
Appreciation of / experience in compliance-driven environment
Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
Contact Brian Christensen on 01 6854747 or submit your CV to firstname.lastname@example.org for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747