Georgia CTSA KL2 Scholars Program: Career Development for Junior Faculty in Clinical and Translational Science

The KL2 program responds to national efforts to support the training and development of junior faculty members who will become well trained, successful, and independent clinical and/or translational investigators. The KL2 program builds on the considerable strengths and outstanding resources in Atlanta and at Emory, MSM, Georgia Tech, and UGA.

The Georgia CTSA KL2 addresses the recommendations of the National Academy of Medicine and others about the need to intensify efforts to train and retain clinical and translational researchers in order to reverse the dramatic decline of clinical and/or translational investigators entering the research workforce. The rationale for the education and training program includes the expanding need for high-quality clinical and translational research; the necessity for integration of the analytic sciences and clinical and translational research; the need to translate research findings from the bench to the bedside and from the bedside to the community; the importance of interdisciplinary education and training in clinical and translational research; and the extensive expertise in and record of clinical investigation represented by the faculty at the collaborating institutions (i.e., Emory, MSM, Georgia Tech, and UGA).

The MSCR or CPTS programs at either Emory or MSM provide didactic training for those applicants from the respective institutions accepted into the KL2 program. All applicants accepted into the Georgia CTSA KL2 program will be required to enroll in the MSCR program (either at Emory or MSM) or CPTS, although students can take courses in either program and there are some joint courses. The Emory MSCR program is offered by the James T. Laney School of Graduate Studies.

The Emory MSCR program requires a minimum of 30 hours of academic credit that include in-class didactic coursework and a written research thesis. Generally, three semesters of didactic study (10-12 months minimum for full-time students) are required and an optimal time of 18-24 months to complete the program (including the mentored thesis). For most investigators, the period of two years is appropriate to accomplish both the didactic work (one year) and completion of an appropriate investigative research thesis.

The MSM MSCR program is a broad-based multidisciplinary graduate level program in clinical and translational research designed to address the problem of health disparities and the shortage of clinical and translational researchers through a concerted effort to recruit and train doctoral prepared minority candidates for successful careers in clinical and translational research.  The program provides training in the principles and methods of biostatistics, epidemiology, including genetics and clinical trials, big data and informatics, and outcomes research, including health services research, patient centered outcomes research methods and community engagement.

An investigator initiated, hypothesis driven proposal with specific aims will be developed by each trainee. The research proposal must have a “human component,” i.e. interaction with human subjects or specimens obtained from identifiable humans. This will be initially outlined in the application submitted by candidates for the program and will be further refined after enrollment in the KL2 program. If the KL2 scholar’s research project involves a clinical trial, per NIH rules, ONLY clinical trials through the end of Phase IIA are eligible. Progress towards those aims will be updated in required semi-annual reports. It is anticipated that the clinical or translational research project that the trainee is working on under the guidance of their lead mentor will provide the data to be analyzed for their mentored thesis, which is required for those enrolled in the MSCR degree program. Clinical and/or translational research will begin during the first year of the KL2 program. Much of the KL2 scholar’s time in the first year will be devoted to didactic research trainings (e.g., first year of MSCR curriculum). In the second year of the KL2 program, a large portion of the KL2 scholar’s time will be devoted to working on their clinical and/or translational research project, under the guidance of their mentor and completing the MSCR written thesis for those enrolled in the MSCR degree program. The KL2 scholar’s thesis research must be presented to the Georgia CTSA Research Education Executive Committee and the mentoring team at a session scheduled before the final written thesis is submitted to the Graduate School. The KL2 program will provide additional support as well through ongoing functions such as journal club, colloquiums, and special seminars (often in collaboration with the MSCR program or other Georgia CTSA components). Other KL2 scholar’s career development research training activities include leadership training, Science of Team Science training, and mentorship training. The importance of interdisciplinary research will be emphasized in these additional colloquiums and seminars. Each KL2 scholar accepted into the Georgia CTSA KL2 program must submit a mandatory NIH K23 Mentored Patient-Oriented Research Career Development Award or equivalent NIH K award (e.g. K01, K08) grant application by the end of their first 12 months of KL2 funding.

Junior faculty with a doctorate (MD, PhD, MD/PhD, PharmD, or equivalent) at the rank of Instructor or Assistant Professor at Emory, Morehouse School of Medicine (MSM), Georgia Institute of Technology (Georgia Tech), or University of Georgia (UGA) are eligible to apply to the program. Individuals who have accepted a faculty appointment at any of the four collaborating institutions may also apply if they will be on the Emory, MSM, Georgia Tech, or UGA faculty at the date of receipt of the award (e.g., June 1 or July 1). Faculty appointments cannot be dependent upon receipt of this KL2 award. Junior faculty physician candidates should have completed training in a specialty or subspecialty and be board eligible or certified. Non-physician candidates must have a PhD and/or PharmD degrees.

Candidates must be committed to a career in clinical investigation (clinical and/or translational research) and be willing to commit in writing to serve on the faculty of an academic institution pursuing clinical and/or translational research for each year of support received through the KL2 program.

Per NIH guidelines, candidates must be a U.S. citizen or permanent U.S. resident at the time they submit the application. Individuals on temporary or student visas are not eligible.

Also per NIH rules, KL2 scholar applicants may not simultaneously submit or have pending an application for any other PHS mentored career development award (e.g. K01, K07, K08, K22, K23, K25) that duplicates any of the provisions of the KL2 program. Former or current Principal Investigators on any NIH research project grant (e.g. R01, U01) or equivalent non-PHS peer reviewed research grants that are over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to participate as KL2 scholars. KL2 scholars are allowed to hold NIH Small Grants (R03) or NIH Exploratory/Developmental (R21) grants or their equivalents and still be eligible for the KL2 award. Appointed KL2 scholars may apply for NIH K23 or equivalent K grant support; if successful, they transfer to the NIH K award.

Requirements 

The candidate must:

• Be a full time junior faculty member at Emory University, Morehouse School of Medicine, Georgia Institute of Technology, or University of Georgia (Instructor or Assistant Professor or equivalent level) at the time of receipt of the award
• Indicate a strong interest in pursuing a career in clinical and/or translational research
• Be nominated by the candidate's Department Chair (and Division Director if applicable); the Chair must guarantee in writing in the letter of support that a minimum of 75% of the junior faculty's professional time will be protected to pursue clinical and/or translational research training if the candidate is accepted into the KL2 program (an exception is made for a minimum of 50% effort for trainees from surgery or surgical subspecialties)
• Identify an established Emory, MSM, Georgia Tech, or UGA faculty lead mentor who meets approval criteria. Additional faculty members may serve as co-mentors or Advisory Committee members but there must be a designated single lead mentor.

KL2 Application Instructions

UGA applicants must notify the Assistant Director of the Owens Institute for Behavioral Research (OIBR), Kim Cherewick, of their intention to submit a KL2 application. The Owens Institute will provide extensive pre-award proposal support in addition to important communication (to candidate and their department) about internal procedures related to Georgia CTSA. Contact info: Kimberly Silvis Cherewick, ksilvis@uga.edu, 706-542-6078.

All application components should be uploaded to online submission system. Please use online submission system (click to start) to upload your KL2 application files. Once you have started submission by entering your name and email address, you will receive a confirmation email with the link to your KL2 application. You can use this link to upload and update your submission files. Please share your submission link with your Department Chair, Lead mentor, Co-lead mentor (if applicable), and Advisory committee members (if applicable) to upload Letters of Support.

a. Cover Page - Click on the link to view the cover page required.

Formatting your proposal: All sections single spaced, at least one-half inch margins (top, bottom, left, and right). Font size should be 11 points or larger; either Arial, Helvetica, or Georgia typeface.

b. Cover Letter from Applicant should indicate the applicant’s rank (e.g. Instructor, Assistant Professor, etc.) as well as the name of the applicant’s lead mentor. The candidate should indicate their interest in pursuing a career in clinical and/or translational investigation and agree to serve at least one year on the faculty of an academic institution pursuing clinical and/or translational research for each year of support from the KL2 program. The applicant should also state that they will:

• agree to the rules of the KL2 program
• meet with the KL2 program director(s) at least once every six months to review progress
• submit semi-annual progress reports
• keep the program office updated on publications and grant submissions/awards during AND AFTER completion of the program
• complete the MSCR or CPTR program unless you have already graduated
• submit a NIH K23 or other appropriate NIH application (e.g. K01, K08) before the end of their first year in the KL2 program

c. Abstract - 30 lines maximum. Provide an abstract of the entire application (candidate, environment, and research). Include the candidate's immediate and long-term career goals, key elements of the research career development plan, and a description of the research project. In the SF 424 (R&R) Application Guide, there are specific instructions for a K Abstract. Another good place to review funded NIH Individual K abstracts is to study others’ abstracts on the NIH RePORTER (under Activity Code, select K awards).

d. Research and Training Plan: 13 pages total

Specific Aims – 1 page
Candidate Section + Research Strategy – 12 pages

Include a Specific Aims page outlining a brief background for the grant, the hypothesis, and a listing of the specific aims.

As described in the Application Guide, prepare a Candidate Section (Candidate Background; Career Goals and Objectives; Career Development Training Activities) as well as a Research Strategy section (Significance, Innovation and Approach) with a specific focus on the respective K program. The Approachsection will include methods – including human subjects recruitment, statistical analysis plan, anticipated outcomes, potential pitfalls and alternative approaches, and timeline subsections. Preliminary data if any, is not required, but should be included in the appropriate section of the Research Plan.  Preliminary data supporting any aspects of feasibility of the methods is considered to be an advantage. Preliminary data can include published or unpublished findings. Be precise about your role in generating the preliminary data, if any.

The Candidate Section should indicate the candidate’s background and career goals and should also describe the faculty member who will serve as the lead mentor as well as a planned schedule of interactions between the trainee lead mentor and mentoring team (be specific and indicate frequency of meetings, types of interactions, etc.).  For the Career Goals, it is important to describe a compelling plan describing  “Future Plans for NIH Research” which would include at a minimum, a K23, K01, or K08. Applicants who clearly preview the KL2/K12 as a pathway to the NIH K (or similar) tend to receive better scores from reviewers. The Career Development Training Activities should provide a clear description of the didactic training that is planned and may include electives in the second year. Applicants who have already completed a Master’s degree should explain the rationale for the proposed didactic training plan.  The research strategy section will include a hypothesis driven clinical and/or translational research proposal that they would develop under the guidance of their lead mentor as well as plans for didactic and mentored clinical and/or translational research training.  Pilot studies are acceptable.

A Human Subjects/Data Safety and Monitoring Plan (not counted towards the 12 page limit) should be included, if applicable. Please follow the NIH SF 424 Application Guide section for the Protection of Human Subjects.  IRB approval for the research is not required at the time of application but will be required prior to funding.   Another good resource for preparing this section (for all areas of human subjects research) can be found here.

e. Literature Citations: Please include a typical literature citation section at the end of the Research Strategy (not included in the page limit).

f. Budget may be submitted on the NIH SF 424 forms or can be a line item listing and should include applicant’s salary (show total salary as well as 75% requested) along with the current fringe benefit rate which can be found on the Emory Office of Sponsored Programs website. The salary cap imposed by NCATS for KL2 scholars is $160,000 (not including fringes) and thus the Georgia CTSA KL2 Program can support $120,000 in salary support (plus fringes at the respective institution’s federal fringe rate) for 75% effort in the KL2 Program. If the applicant’s salary is above $160,000 then the applicant’s division or department would need to cost share the difference. Also include a technical budget of $25,000 per year (which should include $10,000 in year one for MSCR tuition for applicants who propose to complete the MSCR program, and $2,500 per year maximum for travel. KL2 scholars should plan to attend annual Southeast Regional Clinical and Translational Science Conference and Translational Science meeting in Washington, DC.) and a budget justification of no more than two pages. Do not include items not allowed on Federal Grants such as software, books, and administrative support staff (ask if uncertain).

g. Letters of Support from the lead mentor and Department Chair, and from co-mentors, consultants and advisors - The letter from the Department Chair must guarantee that the applicant will have protected time (equivalent to the salary support provided by the program) to carry out clinical research training if accepted into the KL2 program. If the candidate is in the Department of Medicine, a letter from the Division Director is required in lieu of or in addition to the Department Chair.

The lead mentor’s letter should reflect willingness to serve as mentor for the candidate, the mentor's assessment of the candidate, prior trainees he/she has mentored, a brief summary of the applicant’s research proposal, and a brief summary of plans for mentoring and enhancing the research capabilities of the applicant. If there are co-mentors, consultants and/or collaborators, or an advisory committee, the commitment and role of these individuals should be clearly stated.  The mentor should include detailed information on what portion of the applicant’s time will be devoted to clinical activities and what will be the clinical activities and responsibilities once accepted into the K program. The K program requires a minimum of 75% protected effort (50% minimum for surgery department faculty).

Other letters of support for the candidate from applicant’s consultants and advisory committee members are also required.

Note: these are not letters of recommendation but rather letters of support to mentor the candidate.

h. NIH Biosketch of candidate and lead mentor as well as co-lead mentor (if applicable), advisors and collaborators (if any). The NIH biosketch instructions for the K awards and an example of the NIH biosketch can be found on this website. 

i. Facilities and Other Resources, Equipment: 2 pages.

j. Application fee in the amount of $75.00 payable to Emory University (if your application is successful). If you are currently enrolled at Emory University, no application fee is charged by the University. Deliver to the program office (see below). 

k. Original transcripts from every secondary institution you have attended except Emory. Once you are accepted into the program, your transcripts can be sent by the issuing institution directly to the Laney Graduate School.

(For resubmissions only: Please add a one-page Introduction that outlines the weaknesses and concerns of the previous reviews and how you have addressed those in this submission. This page will not count toward the 13-page limit.)

Selection/Review Criteria

The selection process will be carried out under the direction of the Georgia CTSA Research Education Executive Committee, which has established the rules and regulations for the KL2 program. The goal of the KL2 program is to select candidates who, with proper career development and clinical and/or translational research training, have potential to become independently funded, successful, and ethical clinical investigators. Decisions will be based on the strength of the application submitted by the prospective trainee, the potential of the applicant, the success and track record of the lead mentor in mentoring previous junior faculty members and other trainees and diversity issues. Decisions of the KL2 Review Panel are final. Applications will be scored using the NIH scoring system (1 to 9 point scale).

Plan for Recruitment and Retention of Underrepresented Minorities, Women, and those with Disabilities

The KL2 program is committed to meeting the NIH/NCATS goal and that of Emory University, MSM, Georgia Tech, and UGA to increase the participation of women and individuals from ethnic or racial groups underrepresented in the biomedical and behavioral sciences. Such groups include American Indian or Alaska native, Asian, Black or African American, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander. Applications from women and minority candidates are encouraged. In addition, accommodations will be made to assist any individuals with disabilities so those persons who are qualified applicants can complete the program.

Questions: We encourage interested KL2 candidates to contact the Georgia CTSA education program leadership for questions and assistance with the application process. Questions on the application process can be directed to Cheryl Sroka, Georgia CTSA Research Education Program Coordinator (csroka@emory.edu or 404.727.5096).  For questions, especially technical issues, or problems with the online submission website please contact Alexey Kurbatov (akurbat@emory.edu). Applicants are also encouraged to contact the KL2 Co-Directors for additional information.

Each junior faculty trainee must identify a lead mentor who is an established, independently funded clinical and/or translational science investigator at one of the collaborating institutions (Emory, MSM, Georgia Tech, or UGA). Lead mentors should be established and successful clinical and/or translational science investigators with a strong mentoring track record. Generally this means that the lead investigator must be a federally-funded investigator (e.g., NIH and/or CDC). A faculty mentor may only serve as lead mentor for a single KL2 applicant or scholar at any one time.

A letter of support from the lead mentor indicating their willingness and desire to serve as the trainee's lead mentor should be included in the candidate's application. All KL2 scholars must have mentored clinical and/or translational research training under the direction of their lead mentor. Additional co-mentors or Advisory Committee members are permitted; however, there must be a single lead mentor that is identified. Multidisciplinary mentoring teams are strongly encouraged as is having representation from at least two of the Georgia CTSA partners on the mentoring team or Advisory Committee (Emory, MSM, Georgia Tech, or UGA).

Junior faculty members accepted into the KL2 Program must devote a minimum of 75% professional effort to clinical and/or translational research training (the only exception to this is a minimum of 50% effort for trainees from surgery or surgical subspecialties). Salary support reflecting effort will be provided by the KL2 Program (as well as the costs to cover fringe benefits on that salary). Salary support is based on the KL2 scholar's institutional salary. The maximum salary support that the KL2 Program can provide is $120,000 per year (plus fringe benefits) for 75% professional effort. Ongoing support for year two is contingent upon the trainee making adequate progress in the program. In addition to salary support, a $25,000 per year technical budget will be provided to each KL2 scholar. These funds may be used to pay for MSCR or CPTS tuition (if applicable) while the trainee is in the KL2 Program and can also be used for other research related needs including research supplies, laboratory assays, non-faculty research staff salary support, and travel to national meetings or to receive additional specialized training. Salary support for the lead mentor is not allowed by NIH.

Source of Support

Funding for the Georgia CTSA KL2 Scholars Program comes from the NIH/National Center for Advancing Translational Science [NCATS]) [KL2TR002381].

• KL2 Application Workshop Session 1
• KL2 Application Workshop Session 2

Download the KL2 Brochure