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Job Description
Job Summary: Clinical Trial Capabilities Associate
The Clinical Trial Capabilities Associate is responsible for ensuring investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and closeout.
About Eli Lilly Cork
Eli Lilly Cork is a global healthcare leader headquartered in Indianapolis, Indiana, with a talented diverse team of over 1,600 employees across 38 nationalities.
Responsibilities:
- Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, and serve as the point of contact for a site's ERB and Competent Authority (CA) (where applicable).
- 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.
Requirements:
- 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 a compliance-driven environment.
- Ability to learn and comply with financial and legal guidelines and policies (budget and contract).
- Language capabilities in English and Romanian.