Clinical Research Foundations Mentoring
What is the Clinical Research Foundations Mentoring Program?
The Clinical Research Foundations Mentoring Program is one of the core components of the Clinical Research Foundations Training Program, and is designed to facilitate the overall development of the clinical research professional workforce at UT Southwestern Medical Center (UTSW). At UTSW, the Office of Clinical Research (OCR) has designed a Clinical Research Foundations Mentoring program pairing an experienced clinical researcher (the mentor) with a new member of the clinical research team (mentee). Within this dyad, the mentor advises and guides the mentee through a carefully designed and structured program that introduces critical aspects of clinical research management via interactive activities, role play, review of real-world materials and systems, and mentor-mentee discussions.
There are many benefits to participating in the Clinical Research Foundations Mentoring program, some of which include but are not limited to:
- Learn the workplace culture in clinical research
- Networking opportunities
- Accelerate and strengthen skills development
- Organizational knowledge
What is included in the Clinical Research Foundations Mentoring Program?
The UT Southwestern Clinical Research Foundations Mentoring Program consists of six distinct and highly structured modules of increasing complexity, all carefully designed to promote learning and career development skills that will ultimately benefit the mentee. These modules focus on subject areas that are considered essential toward engaging in clinical research activities on the fundamental level.
Each module consists of two parts: (1), a brief homework exercise that is performed independently by the mentee (around 30min) prior to their planned meeting, and (2), a series of interactive activities between the mentee and mentor which are completed during their meeting that last approximately 1 hour in length per module. The modules contain interactive activities with guided discussion points to direct the conversation so that the mentee not only achieves knowledge objectives, but to promote engagement in activities designed to interface with the current research environment at UTSW. Some examples of activities offered within the modules are:
- Homework - Listening to podcasts, watching NIH videos, completing website scavenger hunts
- Meeting Activities - Practice data gathering and review, rehearse informed consent collection, work on setting SMART goals
Participants accepted into the Clinical Research Foundations Mentoring Program will cover the following modules:
Introduction to Mentoring Program and Establish Goals
Knowledge Objectives:
- Recognize the benefits served through mentoring and prepare for a successful experience
- Review SMART goal structure and create a goal
- Outline a plan for future meetings
Brief Activity Outline: Meet and greet discussions and review of the code of mentorship. Discussions and implementation of SMART goal. Review of Clinical Research Foundations Training to date and plans for the mentoring program.
Data System Management at UTSW
Knowledge Objectives:
- Understand how effective data collection, management, and quality are the foundation for all clinical research activities
- Identify and understand processes that assure data quality. Recognize the importance of data security
- Identify data that contains Protected Health Information (PHI) or restricted information
Brief Activity Outline: Talk about research process, focusing on the data. Review Electronic Data Capture (EDC) system access and practice use of the Electronic Medical Record (EMR). Review and practice identification of PHI in study records.
Study Protocols and Informed Consent
Knowledge Objectives:
- Identify the major components of a study protocol
- Recognize the importance of conducting informed consent per Good Clinical Practice standards
- Be able to describe in plain language the risks and benefits of participating in a research study to a potential patient
Brief Activity Outline: Review a study protocol and identify important components. Review an informed consent form, practice obtaining informed consent and observe informed consent discussions.
Adverse Events and Reporting
Knowledge Objectives:
- Be familiar with the concept of unanticipated/adverse events and understand where to locate UTSW resources for reporting, including timelines
- Review Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO)
- Comprehend the significance of reporting based on government regulations
Brief Activity Outline: Review situations that require reporting and associated timelines. Review a study AE log in relation to study protocol. Practice data collection for AE reporting.
Project Management of Clinical Research
Knowledge Objectives:
- Possess a basic understanding of how the clinical research management systems work together at UTSW for subjects on study
- Be familiar with Scope of Practice when implementing research activities
- Apply the above-referenced knowledge or understand the steps toward successfully scheduling a subject’s research visit
Brief Activity Outline: Review role and job description to determine appropriate scope of practice. Review clinical research visit coordination and practice a study visit scenario.
Ethical Conduct of Research
Knowledge Objectives:
- Apply lessons learned from previous modules to recognize the best course of action to take when faced with a challenging situation
- Be aware of resources and when to reach out for assistance
- Review the successful resolution of the SMART goal or discuss a plan to finish it outside of the program
Brief Activity Outline: Review a series of ethical situations and discuss the best course of action. Discuss available support resources and review SMART goal completion.
The Clinical Research Foundations Mentoring Program has been designed to occur over a period of several months. The initial meeting (Module 1) is expected to occur within the first 30 days of the new hire start date. However, subsequent meetings can occur anywhere from two to three weeks from the previous module, with the mentee and mentor free to set the schedule dependent on their needs.
How can I participate in this program as a mentee?
The following are the criteria for entry into the Mentoring Program at the Foundations Level:
- New hire or newly transferred to a designated Clinical Research role for less than 30 calendar days, and required to complete the Clinical Research Foundations Training Program. A list of these roles can be found here.
- Signed up for the “Clinical Research Foundations” training through the CITI training platform
Participation in the Clinical Research Foundations Mentoring Program is a required component of the Clinical Research Foundations Training Programand must be completed by individuals onboarding in a Clinical Research designated role. A list of these roles can be found here.
New clinical researchers will be contacted via OCR@utsouthwestern.edu by the OCR@utsouthwestern.edu and are required to fill out a REDCap survey to submit basic data, including current study assignments and needs. The Program Facilitators will review each mentee’s needs and do their best to match them with qualified mentors based on similar work environments (e.g., study phase, observational or interventional design, etc.) as well as additional needs (e.g., exposure to laboratory skills, contracts, etc.). Mentors, mentees, and mentee supervisors will be notified of the program's matches by the Program Facilitator. The OCR will oversee the entire process with check ins privately with both parties and intervene, if necessary, to restructure dyads if there is a disconnect.
How can I participate in this program as a mentor?
The OCR is always interested in recruiting experienced clinical researchers to serve as mentors in our Clinical Research Foundations Mentoring Program. Not only do we appreciate any time and work experience that mentors offer, but we also fully recognize that great mentors can come from a variety of research backgrounds and experiences. Ideally, the OCR is looking for experienced coordinators and/or clinical researchers with at least 3 years combined working experience in research, preferably with exposure to a variety of types of research. Please contact the OCR at OCR@UTSouthwestern.edu if you would like to learn more about becoming a mentor in this program.
Helpful Resources
- Information Sheet: Clinical Research Foundations Mentoring Program - This document explains all the components in the Clinical Research Foundations Mentoring Program with brief descriptions for each segment.
- Mentoring Code of Conduct - This document outlines the Code of Conduct for Mentors and Mentees participating in the Clinical Research Foundations Mentoring Program.
- Instructions to return to the Clinical Research Foundations CITI Course - This tip sheet provides information on how to return to the Clinical Research Foundations CITI Course.
- Clinical Research Handbook - This handbook is intended to accompany and complement the Clinical Research Foundations Curriculum and to serve as an additional resource.
- Clinical Research Onboarding Checklist - This checklist helps support new clinical research personnel with onboarding training required by UT Southwestern, which extends beyond the Clinical Research Foundations curriculum.
- FAQs - For any questions, go visit our FAQ page. If you still need help, OCR@utsouthwestern.edu!
This program was created with support from the Human Research Protections Program (HRPP), Office of Clinical Research (OCR), and the Clinical and Translational Science Award (CTSA) Program.
This content was last updated on 18th April, 2024. For any questions, OCR@utsouthwestern.edu.