Lilly Assistant-Trial Capabilities in Indianapolis, Indiana
Type of Employment:
Full-Time Employment - FTE
Are you seeking a career that makes a difference in the world? Does providing support for clinical trial sites sound interesting to you? Are you passionate about accurately maintaining and representing information critical to the success of an organization? Do you have experience in conducting clinical research and keeping up to date with country/regional regulatory standards? If so, we have the role for you.
North America Clinical Trial Capabilities supports clinical development, a critical component to Lilly's mission of delivering life-changing medicines. The Trial Capabilities Assistant will support all applicable work streams related to activation, maintenance and closeout of clinical trials sites and ensure inspection readiness through a complete, accurate, and readily available Trial Master File.
In this role you will have the opportunity to...
Initiate investigator site activities, including the collection and submission of regulatory documents.
Monitor, track, and ensure site compliance through effective management of timelines and in alignment with company priorities.
Partner and communicate directly with sites to enable start-up and maintain an active partnership with the sites during maintenance and close-out initiatives and handle account requests.
Responsible for financial components including investigator payments, invoice query resolution, and out-of-pocket investigator payments.
Communicate any known site issues and partner with teams to effectively resolve.
Accurately complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
Ensure appropriate archiving of documents to meet Lilly record retention polices and regulatory standards.
Associate's Degree or High School Diploma/GED with 2 years of equivalent experience preferably in a scientific or health related discipline
Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing, if applicable.
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
Appreciation of / experience in compliance-driven environment.
Ability to learn and follow regulatory standards and internal policies.
Ability to work collaboratively with a team
Very good attention to details and focus on accuracy
Self-management and organizational skills.
Proficient in a variety of technology tools
Validated analytical skills
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an outstanding work environment:
Business Week magazine 50 Best Places to Launch a Career
Black Enterprise 2018 list of 50 Best Companies for Diversity
FORTUNE 50 Best Companies for Minorities
Human Right Campaign Corporate Equality Index - 100% score
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 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.
Region: North America
Location Details: Indianapolis, Indiana
Req Id: 53519BR