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Eli Lilly and Company Trial Capabilities Apprentice - R-9474 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. Were looking for people who are determined to make life better for people around the world.Organization Overview: 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.Responsibilities:TheTrial 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, recordsmanagementand 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. Basic Qualifications: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 fieldExperience, knowledge and desire to work in STEMTwo years clinical research or healthcare experience or relevant experience preferredExcellent interpersonal and networking skillsEffective written and verbal communication skillsAbility to work well in a team environmentPositive attitudeStrong organizing/multi-tasking skills and attention to detailLearning agility and self-management skillsExperience with or the ab

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