For Staff

Training

The CTO is committed to having a training program that support its mission Exceptional Research. Exceptional Care. There are many resources available to staff including on-demand trainings and classroom-based trainings. Ethos is an online resource library that references key presentations, policies, and general information to help investigators and research staff meet their day-to-day research responsibilities.

View the Training Calendar View Self Directed Trainings View Classroom Training Materials View Investigator Initiated Trainings

The purpose of the UNC Lineberger CTO Training Advisory Group is to provide leadership and guidance for the training and career growth of UNC Lineberger clinical research staff.

Training Advisory Group Responsibilities

The Training Advisory Group is committed to best practices in the areas of training and development. In collaboration with the CTO staff, the Training Advisory
Group provides input into initiatives affecting training and development. The goals of the group include:

Best in Class Training Program: Develop a training program that supports the growth and development of all employees.
Design, Develop and Deliver Training: Ensure training is consistent with SOPs and regulations and supports the critical tasks of the CTO staff.
Effective Communication: Establish liaisons within the CTO, encourage the participation of, and feedback from, employees in the training program,
and provide accessible information to employees regarding CTO goals and training program.
Accurate and Timely Documentation of Training: Provide quarterly reports of training offered, staff attendance and all training currently in
development and/or review.

Standard Operating Procedures (SOPs)

CTO SOPs outline broad step-by-step instructions on how to carry out clinical research tasks at UNC Lineberger. CTO work instructions outline specific step-by-step instructions with tricks of the trade and other helpful advice

View CTO SOPs and Work Instructions

The purpose of the UNC Lineberger CTO SOP Committee is to provide leadership and guidance for the development and maintenance of office SOPs.

SOP Committee Responsibilities

The SOP Committee is committed to best practices in the areas of SOP development and implementation. In collaboration with the CTO staff, the SOP Committee provides input into initiatives affecting standardization, codification, and implementation of operating procedures. The goals of the group include:

SOP Program Development: Create a program to create, codify, standardize, and review SOPs on an ongoing basis. Subject Matter Experts (SMEs) lead creation of SOPs and Work Instructions for review and approval by the SOP Committee.
Effective Communication: Establish liaisons within the CTO, encourage the participation of and feedback from employees on existing and future SOPs, and provide accessible information to employees regarding SOPs (including any updates and revisions).
Accurate and Timely Review of SOPs: Provide clear feedback on and edits to SOPs and finalize SOPs according to established timelines with input from all relevant users.
Creation of SOPs to Ensure Compliance: Lead creation and review of SOPs and Work Instructions in response to identified noncompliance with the regulations or other applicable procedures due to lack of standardized understanding or CTO Office processes.

Policies

CTO policies define overall processes and guidelines related to the management, development, and oversight both clinical research and staff.

View Policies

Professional Development

The CTO views professional development as incredibly important to establishing its culture of continual learning and improvement. Professional development support for CTO staff serves multiple purposes:

To improve knowledge and best practices surrounding clinical research
To network with clinical research staff from other academic institutes and industry
To train individuals engaged in specific initiatives
To share best practices and learnings from UNC Lineberger building its reputation and promoting its clinical research team
To create collaborations with industry and other academic institutions
To provide growth of leadership and establish leadership best practices
To support the career growth and development

View the CTO Professional Development Policy View Opportunities on Carolina Talent Learn More About the Tuition Waiver Program

Career Ladder

CTO has a robust career ladder that defines the pathway to progression within the office. The career ladder’s purpose is to provide clarity, direction and structure for staff to grow in their roles and develop over time through roles within multiple levels of the organization

View Our Staff Roles

Oversight Committees

UNC Lineberger Comprehensive Cancer Center clinical research is conducted with a commitment to patient safety, research quality, and institutional integrity. This oversight committees address the monitoring of patient safety and assessing study progress; the reporting of adverse events and unanticipated problems; and the accuracy and integrity of research data and protocol compliance.

Protocol Review Committee Data & Safety Monitoring Committee Compliance Committee

The intent of the committee is to enhance the quality of clinical cancer research at UNC by providing constructive criticism to investigators and maintaining scientific oversight of the conduct of clinical research. The PRC assesses protocols in terms of resource utilization and subject recruitment to ensure that institutional resources are being used effectively and that activation of national protocols conforms with the research aims of UNC. The committee judges the acceptability of protocols based on:

Background data justifying the proposed research
Scientific design and merit
Risk/benefit ratio
Biostatistics
Feasibility
Resource utilization
Application format

The UNC Lineberger Data and Safety Monitoring Committee (DSMC) provides ongoing safety monitoring for all cancer center investigator-initiated oncology clinical trials. This includes therapeutic, as well as interventional basic science, diagnostic, prevention, screening, and supportive care studies.

The Committee’s main purpose is to support investigators and staff by ensuring the safety of study participants and compliance with protocols, regulations, and standard operating procedures (SOPs) for the clinical trials conducted at UNC Lineberger.The Compliance Committee reviews and approves all UNC Lineberger Corrective and Preventative Action Plans (CAPAs) for UNC and multicenter sites resulting from an Office of Clinical Trials (OCT) audit. This review may include requiring Root Cause Analysis (RCA/reactive) or Failure Mode and Effects Analysis (FMEA/preventive) sessions be conducted by investigators and staff.

Investigator Initiated Clinical Trials (IITs)

UNC Lineberger’s IIT website has resources for the development and regulatory approval of IITs. It highlights the procedures, staff, and templates designed to support this type of trial, and has on-demand trainings to support the continued education of staff and investigators

View the CTO IIT Resources