Research Team Lead

Description

*** This job is located in Lincoln, Nebraska. Only candidates located in Lincoln/the surrounding area or who indicate an ability/desire to move to Lincoln in their application will be considered.***

Midwest Children’s Health Research Institute (MCHRI) is a component of Complete Children’s Health’s pediatric practice that researches and supports critically important advancements in the field of pediatric health. We have a passion for providing the highest quality healthcare to our families, and a strong reputation for being a great place to work. We are currently looking to add a Research Team Lead

Founded in 1995, Complete Children’s Health is Lincoln’s most innovative pediatric practice. From the beginning, our practice has been a strong advocate for the advancement of health and wellness of children. We have four convenient Lincoln, NE locations. In 2006, MCHRI was established to support late stage clinical research trials and do our part to work toward a healthier future. Our founding beliefs guide us to provide the very best patient care.

We are searching for a Research Team Lead who will direct the operations of our studies and support our Clinical Research Coordinators. They will be responsible for managing trial execution timelines, handling complex patient recruitment, source documentation, and regulatory compliance. This role reports to the Practice Administrator and the MCHRI Medical Director, while working in close partnership with the Research Director.

• Lead daily clinical trial operations across multiple research sites, ensuring compliance with study protocols, Good Clinical Practice (GCP), institutional policies, and regulatory requirements.
• Partner with Research Director to develop standardized study workflows to ensure complex protocols are executed according to study expectations. Implement workflows consistently across all research locations.
• Develops Standard Operating Procedures (SOPs), research workflows and quality-control processes. Communicate any operational barriers/inefficiencies and solutions that have been implemented to improve study efficiency, enrollment, compliance, data quality, and overall research performance to Research Director.
• Supervise, train, mentor, and evaluate CRCs, including onboarding, competency assessment, performance expectations, and ongoing development to ensure compliance with workflows.
• Serve as the primary operational resource for CRCs, providing guidance and resolving complex protocols, patient care, documentation, scheduling, regulatory, and sponsor-related issues.
• Identify performance or training gaps on the team and implement corrective actions in partnership with Human Resources as needed.
• Ensure appropriate participant screening, eligibility determination, enrollment, and informed consent processes in accordance with study protocols and regulatory requirements. Ensure protocol-required visits, procedures, assessments, laboratory collections, investigational products, and other study activities are completed accurately and within required timelines.
• Coordinate communication across research locations to ensure protocol amendments, safety information, sponsor instructions, and operational changes are implemented consistently.
• Oversee accurate, timely, and audit/inspection-ready source documentation including EDC/CRF data entry, regulatory binders, electronic regulatory files, source documents, and study records. Work to resolve sponsor and data-management queries.
• Maintain regulatory compliance and oversee IRB submissions, amendments, continuing reviews, informed consent documents, delegation logs, training records, and essential regulatory files. Ensure adverse events, serious…