Decentralized Trials Program Lead

UNC-Chapel Hill•Chapel Hill, NC

3d•Hybrid

About The Position

The Lineberger Comprehensive Cancer Center ( LCCC ) at the University of North Carolina at Chapel Hill seeks a Decentralized Trials Program Lead to advance the design, launch, and execution of hybrid decentralized oncology clinical trials across the state of North Carolina. This is a hybrid role that integrates program leadership, operational project management, and hands on clinical trial coordination, with a focus on expanding and sustaining decentralized trial activity at UNC Community Sites and with external partners. The Program Lead will provide day to day operational and clinical oversight for decentralized studies, coordinating administrative, regulatory, and study execution activities across multiple locations. Core responsibilities include supporting trial start up and implementation at community locations; developing and maintaining systems to assess and track site readiness, activation, accrual, and participant engagement; and proactively identifying and resolving operational, regulatory, and logistical barriers to participation. The role will collaborate closely with community partners to identify resources and implement solutions that enable efficient, high-quality trial conduct. A central component of this position is building and sustaining strong relationships with investigators, research staff, and institutional champions at decentralized sites. The Program Lead will plan and facilitate pre-launch and study launch meetings; serve as the primary operational liaison between UNC Main Campus teams and partnering sites; and provide regular, structured updates to investigators and leadership regarding site readiness, trial progress, and performance metrics. This role will also identify opportunities to strengthen communication, alignment, and collaboration between central and decentralized research teams and will include routine location via to partners across North Carolina to support face to face engagement, workflow implementation, and troubleshooting. The Program Lead will contribute to the development, review, and continuous refinement of standard operating procedures (SOPs) and work instructions (WIs) tailored to the regulatory and operational requirements of decentralized and community based research. Through this work, the role will help establish consistent, scalable processes that support decentralized trial operations across the UNC network. A substantial portion of this role includes direct, hands on coordination of oncology clinical trials at the academic medical center. This ensures ongoing, practical understanding of institutional workflows, clinical trial operations, and collaboration with hospital partners. As part of this hands on portfolio, the Program Lead will actively coordinate hybrid decentralized trials, gaining firsthand experience with decentralized models of trial conduct. Insights gained will inform operational improvements, internal education, and the development of sustainable infrastructure to expand decentralized trials across LCCC . As a result of the hands-on study coordinating role, position will facilitate the conduct of oncology clinical trials including subject management, data oversight, and operational coordination in compliance with federal regulations, Good Clinical Practice ( GCP ), and institutional policies. Reporting to the Clinical Operations Manager, the Decentralized Trials Program Lead independently manages multiple complex trials across the protocol lifecycle, from activation through closeout. The role provides daily programmatic and team leadership support, contributes to patient care coordination and advising, serves as a preceptor for new staff, and provides ongoing training and frontline guidance. These responsibilities directly support the mission of the UNC Lineberger Clinical Trials Office by ensuring research quality, patient safety, regulatory compliance, and institutional integrity.

Requirements

Knowledge of ICH GCP , Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols.
Excellent organizational skills.
Strong written and verbal communication skills.
Inherent self-motivation.
Demonstrated capacity for working independently and engaging in innovative problem-solving.
Ability to work productively in a collaborative and multidisciplinary environment.
Advanced knowledge of clinical research coordination.
Strong operational skills with demonstrated ability to perform process improvement initiatives.
High level of accuracy and attention to detail.
Strong computer and analytical skills.
Ability to gather data and document procedures.
Ability to plan work and coordinate multiple projects.
Ability to contribute to preparation and delivery of reports, trainings and SOPs.
Customer oriented and ability to work in a team environment.
Ability to lead, train and develop others.
Ability to work on evenings, weekends and/or holidays occasionally required.
Must be willing to commute to UNC community-based settings as needed across the state of North Carolina.
Valid NC Driver’s License.

Nice To Haves

Experience supporting clinical research at community sites.
Experience in Phase I, II, and III clinical research.
Experience navigating medical records and data extraction.
Three years of clinical trial coordination experience, two of which must be in oncology.
Entrepreneurial mindset.
Prior experience with grant writing, program implementation or multicenter coordination.
SOCRA / ACRP Certification.

Responsibilities

Advance the design, launch, and execution of hybrid decentralized oncology clinical trials.
Provide day to day operational and clinical oversight for decentralized studies.
Coordinate administrative, regulatory, and study execution activities across multiple locations.
Support trial start up and implementation at community locations.
Develop and maintain systems to assess and track site readiness, activation, accrual, and participant engagement.
Proactively identify and resolve operational, regulatory, and logistical barriers to participation.
Collaborate closely with community partners to identify resources and implement solutions.
Build and sustain strong relationships with investigators, research staff, and institutional champions at decentralized sites.
Plan and facilitate pre-launch and study launch meetings.
Serve as the primary operational liaison between UNC Main Campus teams and partnering sites.
Provide regular, structured updates to investigators and leadership regarding site readiness, trial progress, and performance metrics.
Identify opportunities to strengthen communication, alignment, and collaboration between central and decentralized research teams.
Include routine location visits to partners across North Carolina to support face to face engagement, workflow implementation, and troubleshooting.
Contribute to the development, review, and continuous refinement of standard operating procedures (SOPs) and work instructions (WIs).
Establish consistent, scalable processes that support decentralized trial operations across the UNC network.
Directly coordinate oncology clinical trials at the academic medical center.
Actively coordinate hybrid decentralized trials.
Facilitate the conduct of oncology clinical trials including subject management, data oversight, and operational coordination in compliance with federal regulations, Good Clinical Practice ( GCP ), and institutional policies.
Independently manage multiple complex trials across the protocol lifecycle, from activation through closeout.
Provide daily programmatic and team leadership support.
Contribute to patient care coordination and advising.
Serve as a preceptor for new staff.
Provide ongoing training and frontline guidance.