Lilly Trial Capabilities Apprentice in Indianapolis, Indiana
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 39,000 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Lilly Professional Apprenticeship Program is a 12-month intensive fixed duration (FDE) professional development program during which the apprentice receives a combination of formal training, on-the-job learning, and mentoring in a key functional area to be equipped to compete for a Lilly position after successful completion of the apprenticeship.
The Trial Capabilities Apprentice (TCA) provides clinical trial capabilities in support of clinical development. The TCA ensures the investigator sites meet requirements to enroll study participants into clinical trials, assisting with activities related to site readiness and supports ongoing activities during site maintenance and close-out. The apprentice is responsible for ensuring clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management and site training. The apprentice will ensure inspection readiness through a complete, accurate and readily available Trial Master File.
Initiate investigator site activities, including the collection and submission of regulatory documents, ensure site compliance to required training, ensuring timelines are met and participation in the customization and negotiation of informed consent documents, site budgets and contracts.
Communicate with clinical trial sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out activities.
Work with business partners to achieve enrollment readiness by completing site activation processes.
Continually maintain a state of inspection readiness and perform required duties for internal and external inspections.
Connect with team members and continuously share insights across the organization.
Accurately populate Vault Clinical systems, IMPACT data, internal systems, and related libraries for future needs.
Understand, comply, and reinforce local regulations, laws and guidance (e.g., FDA, ICH), Quality and Business Systems, and Good Clinical Practices (GCP) to achieve inspection readiness and detect and resolve quality issues.
HS Diploma or Equivalent and 3 or more years of related or professional experience. Proven experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
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.
Additional Skills and Preferences:
At least 1 year of college and/or associate degree in a related field.
Experience, knowledge and desire to work in STEM
Two years clinical research or healthcare experience or relevant experience preferred
Excellent interpersonal and networking skills
Effective written and verbal communication skills
Ability to work well in a team environment
Strong organizing/multi-tasking skills and attention to detail
Learning agility and self-management skills
Experience with or the ability to learn and align with regulatory requirements and internal policies within a compliance-driven environment
Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.
- This position is not permanent. It is for a fixed term position up to a maximum of 4 years.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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