Trial Capabilities Associate

Eli Lilly and Company • Indianapolis, IN

3d • $65,250 - $165,000

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world 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 give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The Trial Capabilities Associate (TCA) provides clinical trial capabilities in support of clinical development. The TCA is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The TCA may be assigned responsibilities within any trial capability, including obtaining clinical trial authorizations and ethics approvals, execution of the budget and contract, and activities related to investigator grants execution. The TCA will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

Requirements

• Bachelor’s degree preferably in a scientific or health related field
• Two years clinical research experience or relevant experience preferred
• Qualified candidates must be legally authorized to be employed in the United States.
• Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Nice To Haves

• 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
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem solving skills
• Self-management and organizational skills
• Language Capabilities

Responsibilities

• Initiate investigator activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for an investigator’s ERB and Competent Authority (CA) (where applicable), communicate and negotiate budgets with investigator personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure investigator (and/or delegate) compliance to required training, track and ensure investigator (and/or delegate) access to required clinical systems and supplies, and effectively drive timelines aligned with company priorities
• Communicate directly with investigators (and/or delegates) to enable start-up and maintain an active collaboration 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 investigator / review board engagements to efficiently drive new work
• Populate internal systems to ensure accuracy of trial / investigator performance
• Understand and comply with procurement, 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
• Coordinate investigator grant responsibilities such as purchase order creation, management, and P2P processes related to payment execution and/or reporting.
• Lead collection efforts for advanced and overpayments and ensure financial reconciliation required for studies for CRF payments and invoiced deliverables are effectively completed.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees