Job Description
Job Summary: Clinical Trial Associate responsible for ensuring investigator sites meet requirements for ongoing activities during site maintenance and close-out, obtaining clinical trial authorizations, and managing clinical finance and records.
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We are looking for a talented and dedicated individual to join our team as a Clinical Trial Associate. This role is located in our Cork GBS Office and requires a strong understanding of clinical development, compliance, and financial guidelines.
Key Responsibilities:
- Leverage trial prioritization to manage site maintenance requests and drive timelines aligned with company priorities.
- Manage site level changes, including changes to Principal Investigator, Sub-Investigator, and site location.
- Facilitate site level informed consent form updates and approval of additional patient-facing materials.
- Complete site close-out verification activities and maintain an active collaboration with sites during maintenance and close-out.
- Address requests related to the Clinical Study Report and ensure TMF Functional Check Placeholders are closed.
- Identify, communicate, and resolve issues, and collaborate with peers and cross-functional partners to ensure effective site management.
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and 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 financial and legal requirements and procedures.
- Populate Trial Master Files and libraries for future reference.
- Provide feedback and shared learning for continuous improvement.
- Anticipate and monitor dynamically changing priorities.
Requirements:
- Bachelor's degree in a scientific or health related field, with three years clinical research experience or relevant experience preferred.
- Understanding of the overall clinical development paradigm and the importance of efficient site activation.
- Appreciation of / experience in compliance-driven environment.
- Ability to learn and comply with financial and legal guidelines and policies.
- Effective communication, negotiation, and problem solving skills.
- Organizational skills.
- Language capabilities in English, with another language appreciated.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.