Research Team Lead

Complete-Children; Lincoln (NE); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Generous PTO

Dental coverage

Job summary

Complete Children’s Health in Lincoln, NE, seeks a Research Team Lead to direct operations of clinical studies, coordinating trial timelines, recruitment, source documentation, and regulatory compliance. You will supervise CRCs, develop SOPs, and ensure quality across locations.

You will work with the Research Director and PIs to optimize workflows, maintain audit-ready files, and uphold patient safety and data integrity. A nursing/health sciences background with leadership is preferred.

Qualifications

• Bachelor's degree in nursing, health sciences, life sciences, clinical research, public health, or related field.
• Three to five years of progressively responsible clinical research experience, including coordinating clinical trials and managing study activities from initiation through close-out.
• At least two years of leadership, coordination, training, mentoring, or operational oversight of clinical research staff or activities.

Responsibilities

• Lead daily clinical trial operations across multiple research sites, ensuring compliance with study protocols and regulatory requirements.
• Develop standardized study workflows and SOPs; communicate barriers and improvements to Research Director.
• Supervise, train, mentor CRCs and ensure adherence to workflows.

Skills

Team leadership

Attention to detail

Collaboration

Regulatory compliance

IRB familiarity

Education

Bachelor's degree in nursing/health sciences/related field

Job description

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

WHO WE ARE:

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.

THE OPPORTUNITY:

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.

Essential Functions:

• 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 adverse events, protocol deviations, and other safety information are appropriately documented and reported within required timelines.
• Collaborate with Principal Investigators and Sub-Investigators to identify eligible participants and oversee recruitment, prescreening, enrollment, scheduling, and participant follow-up.
• Assist the Clinical Research Director with study feasibility assessments by evaluating patient population, staffing, visit schedules, laboratory and equipment needs, and operational complexity.
• Monitor staffing and workload across sites, identify operational risks affecting recruitment, patient safety, data quality, or study timelines, and escalation concerns to Practice Administrator.
• Provide cross-coverage and coordinate additional support during staffing shortages, high enrollment periods, or complex and high-priority studies.
• Lead quality assurance activities, including review of research records, informed consent documentation, regulatory files, protocol compliance, and identification of trends in errors or protocol deviations.
• Work with the MCHRI Medical Director, Research Director, PIs, and Sponsors to implement staff training, workflow improvements, and corrective and preventive actions (CAPA) to improve quality and compliance.
• Serve as the operational liaison between the Research Director and research staff, communicating priorities, staffing needs, workflow concerns, and ensuring decisions are implemented across all sites.
• Promote consistent, high-quality research practices across all locations with a strong focus on patient safety, protocol compliance, data integrity, enrollment performance, teamwork, and timely study execution.

You will need:

• A desire to lead a team, helping to define and guide processes.
• Excellent attention to detail – clinical research is highly regulated and compliance is of the utmost importance.
• A collaborative mindset. Whether it's with the Principal Investigators, Research Coordinators, the Research Director, or the broader clinic, you will be working with others a lot!
• Knowledge of clinical research principles, practices, and terminology; Institutional Review Board (IRB) requirements, processes, and expectations; informed consent requirements and ethical principles; team leadership; study start-up, participant enrollment and follow-up, study close-out processes; protocol deviations and adverse event follow-up requirements; developing Standard Operating Procedures, research workflows, and training.

WHY YOU SHOULD APPLY:

• A commitment to family-friendly work schedules. Be home for dinner. Flexibility is important to this team.
• Rewarding work that positively impacts the health and wellness of children, both in our community and beyond it.
• Competitive pay and a complete benefits package, including health insurance, generous PTO, and more! In addition, we have free options for employee health and dental coverage on select plans.
• You want a better job, and in a place with a fun and collaborative culture!

Complete Children’s Health is an equal opportunity employer.

Requirements

We are seeking a candidate with:

• A bachelor's degree in nursing, health sciences, life sciences, clinical research, public health, or a related field, or an equivalent combination of education and directly related clinical research experience.
• Phlebotomy experience, pediatric phlebotomy experience preferred.
• Three to five years of progressively responsible clinical research experience, including experience coordinating clinical trials and managing study activities from initiation through close-out.
• At least two years of experience providing leadership, coordination, training, mentoring, or operational oversight of clinical research staff or clinical/research activities.

In addition, an LPN or RN license is desired. In lieu of a nursing license, additional related education and/or experience may be substituted. Without a nursing license, a valid state medication aide license will be necessary to perform the duties of this role. Experience with blood draws is required regardless of licensure. Within a month of hire, CITI and IATA certifications must be achieved. Any license held must be in good standing in the State of Nebraska.