For Investigators | Clinical Trials Office

Onboarding

The Investigator Onboarding Program is a springboard that provides Investigators new to UNC or working with Lineberger resources to begin their research journey. This includes but is not limited to assistance with HIPAA and CITI training, functional group contacts to facilitate the transition to UNC, or initiation of, any grants or clinical protocols, and resources and contacts to assist Investigators in understanding Lineberger process to obtain protocol approval and what resources are available for ongoing protocol maintenance and compliance.

Training

The UNC Lineberger Oncology Clinical Trials Course is a course designed for faculty and trainees interested in clinical trials research.

Topics include: Trial design, conduct of trials, relevant regulatory ethics and data management issues, barriers and challenges, and career development, as well as adjuncts to therapeutic trials including biomarkers and correlative studies. The intended audience is all interested fellows, APPs, or faculty in a cancer-related division or department.

Previously Recorded Clinical Trials Course Lectures

Investigator Initiated Trials (IITs): Developing, writing, operationalizing, and conducting clinical trials is incredibly complex. To aid in investigator continuing education about some of these complex processes, we have put together the following on-demand lectures. They cover a variety of topics from creation of a clinical trial to responsibilities associated with sponsoring a clinical trial to business principles surrounding project management of activating clinical trials.

Investigator Initiated Trial Trainings

Investigator Initiated Trials

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

What are the responsibilities of a POD leader or investigator?

When to ensure productive and collaborative working relationships with the CTO, UNC Lineberger leadership has defined the role of an investigator and POD Leader within our organization.

POD Leaders	Investigators
Maintain POD Fiscal Responsibility Review POD fiscal reports biannually Build balanced POD portfolios Promote POD accrual	Maintain POD Fiscal Responsibility Accrue to your clinical trials
Build the POD Portfolio Build a research portfolio that meets the needs of the patients and disease-group strategic priorities including diverse patient enrollment Balance the portfolio with different sponsor-types, Provide justification activation slot requests from the Director’s discretionary pool	Build the POD Portfolio Contribute to a research portfolio that meets the needs of the patients and disease-group strategic priorities including diverse patient enrollment
Partner with Clinical Research Leadership Partner with and respect CR leadership as your primary teammates (first-team) Escalate operational or staffing concerns to managers and CR leadership Provide real-time feedback to leadership on staff performance	Partner with POD Leader and Clinical Research Leadership Escalate operational or staffing concerns to POD leader Provide real-time feedback to leadership on staff performance
Support the POD Staff and Office Culture Participate in staff recruitment/retention (e.g., interview and provide feedback upon request) Participate in staff onboarding (meet and greets with all new POD staff, provide disease specific training) Foster a culture of gratitude (e.g., say thank you, share positive feedback with managers) Promote work/life balance by appropriately contacting only during business hours via approved communication methods Respond to staff emails/questions within two business days Share knowledge Support building a diverse workforce	Support the POD Staff Participate in staff recruitment/retention (e.g., interview and provide feedback upon request) Foster a culture of gratitude (e.g., say thank you, share positive feedback with managers) Promote work/life balance by appropriately contacting only during business hours via approved communication methods Respond to staff emails/questions within two business days Share knowledge with staff
Lead the POD Meetings Complete POD Leader onboarding Maintain familiarity with the POD meeting SOP Assist with sponsor/monitor queries and escalated POD issues Initiate/Lead quarterly team-building events Review enrollment demographics monthly and develop plans to address deficiencies	Attend POD Meetings Complete Investigator onboarding, Participate in quarterly team-building events
Mentor the POD Investigators Conduct clinical research in compliance with GCP, FDA and ICH Ensure engagement in monitoring visits and responding to sponsor/staff queries Ensure timely response to staff emails/questions Review monthly POD investigator accrual reports and encourage investigator accrual	Be a Good Clinical Research Citizen Conduct clinical research in compliance with GCP, FDA and ICH Be engaged in monitoring visits and responding to sponsor/staff queries

Recognize our staff

The CTO believes in a culture of gratitude and wants to recognize our staff for the great things that they do on the day-to-day. We highly encourage our investigators to email our leadership team with praise and recognition for the staff on our teams. You can contact the known manager directly or reach out to anyone in CTO leadership! To send kudos about the performance of our staff, click the link below.

Send Kudos

Learn more about our office

The CTO is defined to support all of you and our patients as we enroll on many types of clinical trials. We view the CTO to be an active partner with investigators in ensure that they have staff who are high performing and supported in their roles. Ask about our investigator engagement policy if you want to learn more about the CTO leadership and investigator partnership.

Meet Our Leadership

View Our Staff Roles

Search Clinical Trials

Find cancer clinical trials at UNC Lineberger Comprehensive Cancer Center.

View Open Clinical Trials