CTSA KL2

Program Overview

Historically, scientists have been trained to conduct research within their own individual disciplines. Such a single-discipline approach to complex biomedical and health-related problems is unlikely to generate comprehensive solutions or to efficiently move discoveries from the basic science laboratory to clinical trials and into the practice setting. More recently, the NIH and others have recognized the need for a paradigm shift in which investigators from diverse fields form interdisciplinary teams in order to expedite the translation of research results into practice. Thus, applicants for the KL2 Program should propose an area of research that is translational, or, seeks to improve the health of the population by transforming discoveries from laboratory into clinical practice in community and health policy.

The objective of the CTSA KL2 Program is to train and develop junior investigators. These investigators will become the next generation of successful clinical/translational researchers who will lead and/or participate in the research teams of the future. Through a combination of didactic training, access to expert faculty and support for salary and research, KL2 Scholars will gain:

  • An appreciation of the spectrum of clinical/translational research including new technologies, regulations and ethical principles that influence the translation of research results into practice;
  • An understanding of methodological and analytical concepts necessary to design rigorous clinical/translational research;
  • An opportunity to apply their knowledge through research experiences that will contribute to future grant proposals; and
  • An opportunity to work with a mentoring team consisting of faculty members who are expert in the career development of researchers and committed to the Scholar’s success.

KL2 Scholars are required to devote 75% of their time to research and training (Individuals in certain specialities may request permission for reduced research time. This should be discussed with Susan Pusek prior to applying). The KL2 grant will support this time and provide the scholar with up to $25,000 in research funds per year. In addition, KL2 Scholars have access to dedicated biostatistics and epidemiologic support as well as faculty who are expert in the career development of researchers.


Applicant Eligibility

  • KL2 scholars must have a research or health-professional doctoral degree or its equivalent;
  • Not be or have been a PD/PI on an R01, R29 or subproject of a Program Project (P01), Center (P50, P60, U54) grant, independent mentored career development (K-series) grants, or other equivalent research grant awards; except for R03 and R21;
  • Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to appointment, are eligible to accept a KL2 appointment. Individuals on temporary or student visas are not eligible.
Appointments to the KL2 Program usually start July 1, however, applicants may be appointed at other times if current scholars transition off the KL2 to their own funding.


Instructions for Application Submission

  • The application can be used for the KL2, the BIRCWH K12 and the Paul Calabresi K12 in Clinical Oncology. Applicants will be asked to note which program(s) they wish to be considered for on the application.
  • If you are not a member of NC TraCS you will need to join to submit an application.
  • Application Deadline for all programs: 8:30 am on April 26, 2013.
  • Application

The application can be used to apply for either the KL2, the BIRCWH career development awards, and/or the Paul Calabresi K12 in Clinical Oncology programs.

If you decide to submit an application, please notify Susan Pusek of your intent to apply and a working title so the assignment of reviewers can be expedited. A working title is required to submit an application.

Page limitations have been noted for certain sections. Please adhere to them as one of the criteria for KL2/BIRCWH review (and NIH review) is the ability to describe your research plan within the page limits.


Following Application Submission

Interviews
Once complete, the application will be reviewed and two reviewers who are members of the Interdisciplinary Advisory Committee will be assigned. You will be given contact information for each reviewer so that you may set up an interview. (If you are an outside applicant we will contact you to determine the next steps.) For applicants who are currently at UNC, these interviews should occur no later than 8:30 am on May 31, 2013.

You will also be asked to interview with faculty from the Education, Training and Career Development Core. These interviews will be arranged by Susan Pusek and will occur no later than May 31, 2013.

Selection of Scholars
The meeting to select Scholars will be held in June. You will be notified as soon as possible after the meeting.


Program Components

Training
The institutional KL2 Program is designed for individuals who need mentorship and additional training to achieve their research and career goals. Training that could be proposed includes: formal courses (with or without a degree such as the MPH or Masters of Science in Clinical Research); workshops; internships; or practica.

All KL2 Scholars are required to take courses that comprise the Translational and Clinical Research Curriculum (TCRC), either for credit (as part of a formal degree granting program) or audit (without academic credit). Applicants should note on the application if they have taken these courses already as part of another training program (e.g., a T32) and if this is the case, applicants may propose alternative training options. The TCRC courses are designed to provide participants with foundational skills that align with national CTSA core competencies for all clinical/translational researchers, regardless of specific type of research. The three required courses are described below; applicants should use the Career Development Plan section of the application to describe other training activities they propose as a KL2 Scholar.

Required Courses

Epidemiology 896 Clinical Research and Professional Development Seminar
Fridays 12-2 pm for 2 years
This seminar introduces participants to scholarly exchange of ideas, the value and process of peer review, and examples of applied clinical/translational research concepts across the entire spectrum of disciplines and types of investigations. The course has traditional lectures, panel presentations, outside speakers works-in-progress seminars, small groups, and mock grant reviews to facilitate participants’ research from inception through submission of grants. These sessions are designed to achieve national CTSA core competencies for all clinical/translational researchers.
K Seminar
First and third Fridays of the month from 1-2 pm
This seminar consists of each scholar presenting his/her work in progress, draft specific aims for a grant, or rehearsal for a national talk. Note: If you have taken the 2-year cycle of EPID 896 you should still plan to participate in the K Seminar.
Responsible Conduct of Research (RCR):
Applicants have a variety of options to obtain RCR training and will be required to have basic RCR training prior to appointment to the KL2.


Optional Courses (depending on research progress and past training)

EPID 805-6 Clinical Research Skills
Fridays 2-4 pm
KL2 Scholars are expected to write a grant proposal during their second year in the KL2 Program. To facilitate that process, an intensive course in proposal development, including project management and implementation. Participants in this 2-semster sequence should be ready to write a proposal for either a career development award (NIH K award or foundation), an investigator initiated research grant to NIH (R01, R03, R21, etc.), or a foundation. Substantial mentor involvement in the development of the project proposal is required. All participants are required to remain in the course for the full year which will culminate with a mock review of the proposal prior to submission. If your research is at a stage in which you will be preparing a proposal to submit for funding by the end of year 1 of the KL2 (e.g. June 2014), you should plan to take EPID 805-6 in year 1. Otherwise, plan to take it in year 2 with a goal of proposal submission after the course.
PUBH (Biostatistics) 741-742 Quantitative Methods for Health Care Professionals
Fall Tues/Thurs 12-2 pm, Spring Thurs 12-2 pm and Fri 10-12 pm
This 2-semester sequence provides participants with basics of statistical inference, practical experience in analyzing clinical and health care research data sets, ability to appraise critically the design and analysis of studies in the medical and health care literature, and an understanding of the overlap between standard statistical and epidemiology methods. These courses are structured to provide scholars with practical, hands-on opportunities to demonstrate their competencies, including commonly used statistical packages.
Epidemiology 711 Clinical Measurement/Evaluation
Fall Tues/Thurs 2-3:15 pm
Lecture/problem-based introduction to fundamental epidemiological concepts of research, with an emphasis on study design, measurement and analysis.

Other Potential Courses
Depending on training goals EPID 802, EPID 803, and/or EPID 804 can be considered. Course descriptions are available. Applicants may propose other courses either at UNC or other institutions depending upon training goals.


Research
The KL2 Program provides salary support and research funds so applicants can conduct research project(s) that will ultimately lead to submission of an application for their own funding. Applicants have a choice to propose an optional research internship and an independent research project, or begin with the independent research project. Further details on each are noted within the application instructions but these experiences are expected to generate preliminary data that will be used to support the applicant’s future grant submissions. Notably, as described above, all scholars are expected to submit a grant proposal during their second year in the KL2 Program. Thus, applicants should work with their mentors to design a project that is feasible and has a high likelihood of resulting in data to support future research.

Mentoring
The KL2 Program seeks to recruit and train a diverse group of scholars representing science across the spectrum of translational research. Each scholar is expected to identify a Lead Mentor and a mentoring team that is interdisciplinary and can provide content expertise, networking assistance and career planning for the scholar within his/her chosen field. The Lead Mentor has primary responsibility for working with the KL2 Program leadership to make sure the scholar makes progress and to identify and resolve any challenges. The Lead Mentor and other members of the mentoring team must sign a mentoring agreement defining expectations and responsibilities.

Integration with NC TraCS Institute
The KL2 Program is administered by the Education Program of the NC TraCS Institute and funded through the Clinical and Translational Science Awards program of the National Institutes of Health. The Education Program supports numerous programs for researchers across training levels and disciplines. As a result, KL2 Scholars benefit from a wide variety of career development resources including organization of mock proposal reviews, the R-Writing Group, mentoring opportunities and a Responsible Conduct of Research program specifically for K awardees across the UNC campus.

KL2 Scholars also have access to all resources offered by the NC TraCS Institute. Examples include: assistance for regulatory questions, access to pilot funding, advice on dissemination/implementation of their research results, a full-time research subject recruiter, commercialization/intellectual property assistance and bioinformatics.


Questions about the application process can be submitted to Susan Pusek by email or by phone at 919-966-0128.

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