Trial Capabilities Associate

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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

The Trial Capabilities Associate (TCA) provides clinical trial capabilities in support of clinical development.  The TCA is accountable for performing clinical trial site activation activities 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, and activities related to investigator grants execution but will primarily focus on the execution of budgets and contracts. 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. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Clinical Trial Responsibilities

• Initiate investigator activities, including conducting complex budget and contract negotiations and developing innovative process solutions The TCA will effectively driving timelines aligned with company priorities while balancing the highest degree of quality with a streamlined, and customer focused approach.
• Communicate directly with investigators (and/or delegates) to enable start-up and maintain an active collaboration, ensuring all parties understand and agree to obligations and timelines
• Drive acceleration in budget and contract activation activities through collaboration and innovative solutions.
• Balance accelerated and aggressive timelines of clinical development with ensuring quality and compliance with global regulations and Lilly’s policies.
• Identify areas for process improvements with accountability for streamlining budget and contract activities and driving innovation.
• Identify, communicate, and resolve issues
• Leverage previous investigator records 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 and receive feedback. Participate in shared learning, striving for continuous improvement
• Anticipate and monitor dynamically changing priorities
• Coordinate with regulatory associates and may be required to collect and submit regulatory documents, customize and negotiate informed consent documents and serve as the point of contract of investigator’s ERB and Competent Authority, 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.
• May be required to 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.

Minimum Qualification Requirements:

• Bachelor’s degree required; preferably in a scientific, health, or business-related field
• Minimum of two years of clinical research experience, specifically in negotiating clinical trial budgets and contracts or relevant experience
• 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
• Effective communication, negotiation, and problem-solving skills
• Ability to analyze and interpret information to draw conclusions that are readily explainable, Self-regulation, self-motivation, and organizational skills
• Ability to lead and influence projects and peers without official authority
• Collaboration focus and strong motivation to continually grow and develop
• Language Capabilities: Proficient in English; additional language skills are a plus

Other Information/Additional Preferences:

            None

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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