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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. It facilitates the overall development of the clinical research professional workforce at UT Southwestern Medical Center (UTSW).

Designed by UTSW’s Office of Clinical Research (OCR), the mentoring program pairs an experienced clinical researcher (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, a review of real-world materials and systems, and mentor-mentee discussions.

Benefits to participating in the Clinical Research Foundations Mentoring Program include:

  • Learning the workplace culture in clinical research
  • Discovering networking opportunities
  • Accelerating and strengthening skills development
  • Improving organizational knowledge

What Is Included in the Clinical Research Foundations Mentoring Program?

The 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 for engaging in clinical research activities on a fundamental level.

Each module consists of two parts:

  1. A brief homework exercise that is performed independently by the mentee (around 30 minutes) prior to their planned meeting
  2. A series of interactive activities between the mentee and mentor that are completed during their meetings, lasting approximately one hour in length per module. The modules contain interactive activities with guided discussion points to direct the conversation. The activities help the mentee not only achieve knowledge objectives but also 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

Clinical Research Foundations Mentoring Modules

Participants accepted into the Clinical Research Foundations Mentoring Program will cover the following modules:

  • 1. Introduction to Mentoring Program and Establish Goals

    1. 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 a review of the Code of Mentorship; discussions and implementation of a SMART goal; review of Clinical Research Foundations Training to date and plans for the mentoring program

  • 2. Data System Management at UTSW

    2. 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

  • 3. Study Protocols and Informed Consent

    3. 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

  • 4. Adverse Events and Reporting

    4. 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; and practice data collection for AE reporting

  • 5. Project Management of Clinical Research

    5. 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 to gain an understanding of the steps needed to successfully schedule 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

  • 6. Ethical Conduct of Research

    6. 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 is designed to occur over 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 after 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 criteria for entry into the Clinical Research Foundations Mentoring Program are:

  • New hire or newly transferred for less than 30 calendar days in a designated clinical research role that requires completion of the Clinical Research Foundations Training Program. See a list of these roles.
  • Signed up for the Clinical Research Foundations Training through the CITI program platform

Participation in the Clinical Research Foundations Mentoring Program is a required component of the Clinical Research Foundations Training Program and must be completed by individuals onboarding in a designated clinical research role.

New clinical researchers will be contacted via 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 facilitator. The OCR will oversee the entire process by checking in privately with both parties and will 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 the 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 coordinators and/or clinical researchers with at least three years of combined work experience in research, preferably with exposure to a variety of types of research. Please OCR@UTSouthwestern.edu the OCR if you would like to learn more about becoming a mentor in this program.

Helpful Resources

This program was created with support from the Human Research Protections Program (HRPP), the Office of Clinical Research (OCR), and the Clinical and Translational Science Award (CTSA) Program.

Frequently Asked Questions

  • What are the benefits of being a mentee?

    There are many benefits to participating in a mentoring program as a mentee:

    • Access to mentor's expertise
    • Vital feedback in key areas
    • Learning specific skills and knowledge relevant to personal goals
    • Larger networks with more people across UTSW
    • Learning about the organization's culture
    • A resonating phenomenon (i.e., mentees become mentors themselves)
    • Multiple types of support, including career and psychosocial support
  • I primarily work at another hospital. Can I enroll in this program?

    We recognize that employees at UTSW's affiliated institutions may wish to enroll in our Mentoring Program and we are currently working with our partner institutions to integrate this program into their onboarding processes. For further information or queries about this, please email the OCR.

  • I started the Clinical Research Foundations Mentoring Program but don't think I can find the time to finish. What do I do?

    First, thank you for recognizing that you're facing challenges with finding the time to finish the program. We get it! Situations change all the time. However, we want to make sure you succeed in this program and it is a requirement for research onboarding. Please email the OCR so we can review your situation and discuss options.

  • I am not going to be able to complete my SMART goal by the end of the sixth module. Can I still get my Certificate of Completion?

    Completion of the SMART goal is a major component of the Clinical Research Foundations Mentoring Program's requirements. If you are unable to complete your SMART goal during the program, mentees will be offered the opportunity to continue to work with their mentor beyond the program's structured length. Both parties should agree to continue their mentoring, if appropriate. Alternatively, the mentee can discuss with and ask their supervisor and/or manager to take over as the new mentor designee until the SMART goal's completion. If neither the supervisor nor the manager is available, the mentee may email the OCR to make alternate arrangements.

  • What are the benefits of being a mentor?

    There are many benefits to participating in a training program as a mentor:

    • A chance to build connections in the UTSW research community
    • Exposure to unique problems and perspectives
    • An opportunity to develop leadership and coaching skills
    • Information exchange both ways; mentor gains insight from mentee
    • Satisfaction of sharing expertise with others
    • Gaining an ally in promoting the organization's well-being
    • More knowledge about other areas of the organization
  • What are the criteria for joining the Clinical Research Foundations Mentoring Program as a mentor?

    Ideally, the OCR is looking for coordinators and/or clinical researchers with at least three years of combined work experience in research, preferably with exposure to a variety of types of research. Please OCR@UTSouthwestern.edu the OCR if you would like to learn more about becoming a mentor in this program.

  • I don't think it's working out with my (mentor/mentee). What should I do?

    Ultimately, this program is meant to be enriching and rewarding for all participants. However, we recognize that sometimes a mentor-mentee pairing may not work out. If, for any reason, one or both members find this mentoring program experience unsatisfactory, then we want to immediately address those concerns and either resolve the situation or reassign parties as needed. If you have any concerns, please OCR@utsouthwestern.edu the OCR, so we can work with you to find a solution and put you back on the right path.

  • I found an issue with something in the Clinical Research Foundations Mentoring Program's activity sheets. Who do I notify?

    We are grateful for all notifications regarding broken hyperlinks, information that is out of date, etc., in our program documentation. Please OCR@utsouthwestern.edu the OCR and we will ensure updates are made in a timely manner for the benefit of all the program participants.

This content was last updated on April 18, 2024. For any questions, CRAadmin@utsouthwestern.edu the OCR.

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