MCD-CTS (KL2) Application Details & Application

The Mentored Career Development in Clinical and Translational Science (MCD-CTS) is a three-year program created to support research career development for health professionals or individuals with research doctoral degrees who wish to pursue formal training and a career in clinical and translational research. 

MCD-CTS Program advocates Scholar diversity under an Inclusive Excellence framework to promote unique perspectives and innovation in research. The program welcomes and encourages applications from junior faculty members who are underrepresented minorities - Black, Indigenous and People of Color (BIPOC), LGBTQIA+, military veteran, disabled - and/or from disadvantaged backgrounds.

To learn more, watch the MCD-CTS Program Information Session video below. 
Please note the 2024 application due dates that are posted in the Application Process Timeline on this webpage.

Elizabeth Burner, MD, MPH, PhD, Interim Director MCD-CTS Program

The MCD-CTS Award includes financial benefits to support the Scholars' educational, research and other program expenses.  

Financial Benefits
The award has provided the following financial coverage:

• Scholar’s salary support up to $90,000 plus fringe for effort devoted to the program (a minimum of 75% is required for non-surgical specialties, 50% for surgical specialties if approved by NIH and SC CTSI).
• Tuition/research costs of up to $25,000  annually for three years:
  • Travel Stipend (Year 1): Scholars may spend up $5,000 as part of the $25,000 on travel related to their research which must be completed in Year 1 of the program. A portion of travel stipend (approximately $2,500) must be used to cover hotel, transportation, meeting registration, food, and printing of poster presentation for the Translational Science Meeting in Washington, DC (mandatory attendance in first year of training to this conference.)
  • Travel Stipend (Year 2): Scholars may spend up $2,500 as part of the $25,000 on travel related to their research which must be completed by Year 2 of the program.

The MCD-CTS program curriculum includes didactic coursework, seminars, individual and group research, and professional conference attendance and research presentation.

Didactic Coursework
The SC CTSI has developed three Clinical Translational Research courses (CTR 1, 2, 3) totaling 12 units which are given under the Department of Population and Public Health Sciences (PPHS). These courses provide an overarching understanding and view of research from the clinical translational perspective. The courses use interactive teaching methods that require participation and engagement by Scholars. The curriculum also includes courses in informatics and research in diverse populations. They must complete 3 units of directed research as well to obtain a Certificate in Clinical Translational Research (CTR) formerly known as Clinical, Biomedical and Translational Investigations (CBTI) (total of 15 units). Completion of MS in CTR will require total of 29 units.

Class attendance to CTR 1-3 is required. Continued funding is contingent upon satisfactory participation (i.e., attendance) from the previous year.

Career Development Seminar Series (CDSS)
These seminar sessions are an additional education component to the program. Sessions are intended to develop leadership, scientific, and communication skills. Each session covers a different topic led by an expert facilitator.

Work-in-Progress
Approximately every six months, Scholars give a presentation on their ongoing research. This provides them with an opportunity to receive feedback from their respective colleagues in the program, their mentors, the SC CTSI MCD-CTS Leadership, and other audience members. Work-in-progress presentations will occur in place of seminar session topics. All mentors are required to attend these meetings.

Translational Science Meeting
All Scholars are expected to attend the annual Translational Science Conference sponsored by the Association for Clinical and Translational Science (ACTS) in the first year of the program. These meetings focus on education sessions designed to provide information on the latest developments in techniques and processes vital to successful clinical translational science. Also, it provides Scholars an opportunity to share their research through presentations and discussions with a large audience of colleagues, peers, and mentors.

Mentors are an integral part of the MCD-CTS program. Each Scholar must have a primary mentor and a co-mentor from a different discipline. The primary mentor should have sufficient independent research support to cover any costs of the proposed research project that exceed the Scholar research funds provided by the MCD-CTS award.

Expectations
During the Scholar’s tenure in the program, mentors are expected to:

• Ensure that the Scholar has 75% protected time to be spent in clinical research and training activities.
• Provide the Scholar with the required guidance and mentoring, and seek the assistance of other faculty and departmental/institutional resources when necessary.
• Attend all MCD-CTS work-in-progress and mentor meeting sessions.

Research Areas
To be considered for the MCD-CTS program, applicants must be pursuing a career path in clinical/translational research. Our program strongly encourages applications from a variety of schools and disciplines (medical, health science, pharmacy, social work, psychology, biomedical engineering, etc.), as well as from individuals from our partner institutions including but not limited to Children’s Hospital Los Angeles. Applicants do not have to have a clinical degree to apply to the MCD-CTS Program, but their career goals and interests must be in multidisciplinary clinical research.

Other criteria:

• MD, Pharm D, DOT, DSN, DNP, DPT, DDS degrees are examples of MCD-CTS  Scholar-eligible professional doctoral degrees.
• Research Ph.D. degree-holders are eligible.
• Junior faculty or those who anticipate promotion to faculty status (Fellows) at the start of the award.
• Have a primary appointment at an SC CTSI partner institution (Children's Hospital Los Angeles).

Career Stage
Scholars must hold a doctoral level degree and be in an early stage of their career as junior faculty who plan to conduct, or are conducting, clinical research. Some Scholars may be at the tenure-track or assistant professor level when they enter the program, but the ideal Scholar could be at an earlier stage. Eligible applicants will have an assistant professor appointment, in any track, by the start of the program. Fellows are eligible if in their final year of fellowship and have support from their department to promote to junior faculty upon completion of fellowship. This must be stated in the letters of support from the department/division chair as part of the application submission process.

Citizenship
In accordance with NIH policy, these awards are only for U.S. citizens, non-citizen nationals or permanent residents. Individuals on who possess a temporary or student visa this includes H1B and J1 visas) are not eligible to participate. A non-citizen national is a person born in one of the outlying possessions of the United States, including American Samoa and Swain’s Island, to a parent who is a non-citizen national. This is a person who is a U.S. national but not a U.S. citizen.

Selection Criteria
All applications will be judged first on their merit, with diversity of the cohort considered primarily among those applications that are judged to be sufficiently meritorious. Applicants from divisions where MCD-CTS Scholars have already been selected are encouraged to apply nonetheless. Given the high quality of applicants that we receive, successful applicants from all Departments/Divisions/Schools will usually need to exhibit extraordinary capabilities, research questions and potential.

Multiple K Awards
The timing of a K23, K08, and MCD-CTS  Scholar application should be discussed with the WD leadership and your mentors. You are not allowed to have both a K-series grant and be a MCD-CTS Scholar at the same time. The timing of your application should take this into consideration. Please contact the SC CTSI MCD-CTS/KL2 Program at KL2@sc-ctsi.org.

Previous K
The NIH allows for each Scholar to be sponsored by K-series programs for no more than 5 years in total. Since the minimum amount of time that any one Scholar may spend in this MCD-CTS program is two years, MCD-CTS applicants may not have had more than three years of support under a previous K program. Furthermore, applicants must justify additional mentored research training or training in a team context.

Receiving a MCD-CTS award does not make one ineligible to apply for a future K08 or K23, however, the total combined K award time cannot exceed 5 years. Therefore, after 2 years on a MCD-CTS grant, a Scholar would be eligible for only 3 years under a K23 or another K award. The anticipation is that scholars will submit K23s, K08s, R-type or U-type grant applications (e.g. R03, R21, R01, and U01) during their time in the program. 

Those who have had a T32 fellowship are eligible for up to 5 years on the MCD-CTS Award after being supported by a T32.

Combining with Clinical Fellowships
The MCD-CTS Program Award funds cannot be used to support clinical fellowship training. However, applicants in clinical fellowships must be in the final year and have confirmed departmental support to be promoted to junior faculty status upon completion of their fellowship to be eligible for the MCD-CTS Program.

External Review
Applications are reviewed using a dual review system. First, they are reviewed by up to two external reviewers who are content experts in the specific area of research, have experience reviewing mentored career development applications, and who do not have a conflict of interest.  The required components of the application which will be reviewed and scored include the: mentoring plan, educational research plan, environment, significance, approach, and candidate as investigator.

The following NIH scoring guidance is used to evaluate and rank applications:

Internal Review
The applications are then evaluated, scored, and ranked accordingly by the internal review committee (SC CTSI Workforce Development program Directors and Co-directors), taking into account the external review committee scores and comments.  Applicants with the highest scores and their primary mentor are invited for an in-person interview with the internal review committee.  These interviews are to evaluate what the candidate's commitment will be to the program and what their goals are for a career in clinical translational research.

It is extremely important that your application be completed correctly and completely. Please adhere to these guidelines as you assemble application materials and information.

Before you begin the application, please download and review MCD-CTS Application Guidelines (version 7/12/24) and MCD-CTS Application Checklist (version 5/31/24). The guideline provides detailed information on application deadline, review process timeline, notification of award, and awardee start date.

The information in the letter of intent allows us to better plan the review process, and assist potential applicants as necessary. 

This letter must not exceed 2 pages in length and should contain:

• Applicant’s contact information
• A brief paragraph describing what you hope to achieve through participation in the program
• A paragraph describing educational and mentoring goals
• A brief paragraph describing the research including the project title that you would like to perform as a part of the program
• The name, contact information, and specialty of the primary mentor and co-mentor
• Provide the names and email addresses to three potential reviewers who are Associate Professor or full Professor status for your application who do not have a conflict of interest with or anyone named within your application. (Refer to the MCD-CTS Reviewer Orientation Guidelines which describes what is considered a conflict of interest for a reviewer.)

Submit your letter of intent via email to KL2@sc-ctsi.org.

Please note all elements of this section must be completed in order to process all awardee paperwork in a timely manner. In some cases, applicants may already have an eRA Commons user name through the Department of Health and Human Services. If an eRA Commons user name has already been obtained, please enter the user name in the area provided for this section. If you do not have an eRA Commons user name, you may register an eRA commons account through the NIH website. 

Additional Information Required by NIH

Demographic information such as citizenship, residency status, country of birth, gender, race, ethnicity, military veteran status, disability, or from disadvantaged background is asked within this section.

The information asked in this section is CONFIDENTIAL and COMPLETELY VOLUNTARY. Refer to MCD-CTS Application Guidelines (version 7/12/24) to provide accurate information when completing this section. 

The following information will need to be completed in this section as well:

• Project Title
• Research Project Address SC CTSI's Translational Priority Areas
  • Pre-clinical development of novel therapeutic and/or diagnostic tool
  • Studies to identify biological or behavioral mechanisms of disease in humans for therapeutic or diagnostic testing
  • Human studies to demonstrate proof-of-concept or proof-of-efficacy/safety of novel diagnostic or therapeutic approaches
  • Translation of research findings to clinical care and community health practices (e.g., effectiveness, cost-effectiveness)
  • Development of novel clinical and translational research tools including novel approaches to information management and analysis
  • Novel approaches and tools for education and dissemination of clinical and translational research findings among researchers
  • Other
• Verification of Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) Submission: Approval or other appropriate clearance for your KL2 research will be required at the time of notification of award (December 31st). You will be required to submit documentation of approval. If your research is categorized as exempt status, we will need appropriate documentation from an institutional entity (e.g., IRB, etc.) indicating it is considered exempt. IRB/IACUC approval may take up to 6 months due to the length and rigor of the process. We suggest you work in concert of appropriate IRB/IACUC submission with that of your KL2 application submission. Please indicate in the online application if you have or have not submitted your proposal to the IRB or IACUC at the time of your KL2 online submission. This will not prevent your application from being reviewed.
• Applicant's Financial Information: Please complete requested financial information which includes selecting the appropriate percent effort applicant intends to commit to for this research/training program. A budget and budget justification are not required as part of the application process. Applicant must provide their annual base salary as well.

If your application is a re-submission from the previous year and received reviewers’ comments, applicants may provide a 1-page summary of response to reviewers’ comments from the previous year.

 Please use 11-point font as well as include applicant’s name, title of the section and title of the specific component in the header (ex. Applicant: John Doe, MD, Re-submission of Application/Response to Reviewers' Critiques).

Guidelines for Letters of Recommendation and Supporting documents for Mentors and Division Chief/Department Chair
Letters of recommendation (maximum 2 pages) should be provided to the applicant as a PDF file by the 

• Primary mentor and Co-mentor(s) (one combined letter with their signatures), and 
• Division Chief or Department Chair. 

Applicants should provide contact information for the Primary mentor, Co-mentor, and Division Chief/Department Chair in the application.

Guidelines for Mentors/Co-mentors
Applicants must obtain a letter of support from the mentors identified on their applications (primary mentor and at least one co-mentor). This letter must ensure that they are willing to dedicate the time to be a mentor. Keep in mind that a potential mentor must be well-established in their career and have substantial funding of their own, as well as experience serving as a mentor.

Applicants must ask both the primary and co-mentor to address the items listed below, as well as any other pertinent information. (Adapted from http://grants.nih.gov/grants/p...):

• A copy of each mentor’s NIH biosketch (no more than 5 pages, follow NIH guidelines for format and content) must be uploaded as a PDF file within the appropriate section of the online application. This is not a required element for the department chair/division chief.
• The candidate’s potential and his/her strengths and areas in need of improvement.
• Plans for monitoring and evaluating the scholar’s progress toward independence.
• Description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate.
• The mentor’s previous research productivity and peer-reviewed support.
• The mentor must comment on applicant’s qualification relevant to study of clinical/translational research and applicant’s commitment to a career in clinical or translational research.
• The qualifications of the applicant to conduct the proposed research project.
• Elaborate on how this award would benefit the applicant in continuing an independent career in this field.
• Elaborate on the potential of the candidate to perform the research project and understand its implications for human disease and improvement of human health, particularly in urban populations.
• Mentors must ensure that they will uphold the required protected time of 75% effort for Scholar.
• If the primary mentor is providing research space and/or financial support, they must indicate the resource component in this letter.

Guidelines Department Chair/Division Chief Letters

Items the letter of support submitted by the Department or Division Chair must address:

• The department chair/division chief must complete the letter of recommendation component, but does not need to submit an NIH Biosketch or list of previous mentees.
• A guarantee to provide a minimum of 75% protected time for the applicant for the three years as MCD-CTS Scholar.
• Comment on the resources that they will provide to support the applicant’s research for the years the applicant is in the program (i.e., specific as to the amount of space, number and kind of staff, clinical and lab resources, and dollars they will make available to the applicant).
• The applicant’s potential for an independent clinical research career in academics.
• The applicant’s current status and his/her potential to obtain a faculty appointment.
• If the MCD-CTS candidate does not hold junior faculty status during application process, the department/division chair must provide assurance that the candidate will be promoted to junior faculty position upon the start of the award.

Miscellaneous letters of recommendations from other collaborators may be provided but are not a required component. 

Please upload all documents in a single PDF document in the following manner:

• Primary Mentors and Co-mentor letter of recommendation (1 letter) and their NIH Biosketches, 
• Department/Division Chair letter of recommendation (only)
• Miscellaneous letters of recommendation

In a collaborative effort with mentors, please provide up to a one page outline/timeline (separately) for each of the following components as part of the mentoring plan:

1. Career Development Goals (up to half page): Provide a description of career development goals including timeline and strategy proposed to meet the goals (e.g., communications skills (written, oral, multidisciplinary interaction, teaching, and research skills).  Please include information on your mentoring team and their expertise, as well as the frequency, duration, and when mentoring meetings will be initiated.
2. Research Project Timeline (up to half page): Provide specific benchmarks and anticipated completion of research project, and
3. Extramural Funding, Manuscript, Meeting Presentation Timeline (up to half page): Provide expectations regarding submission of application for extramural funding, manuscripts, and meeting presentations. 

Please provide a separate page for each component stated above using at least 11-point font.  Do not combine all three components on one page. Upload as combined single PDF document. The header should include applicant’s name, section title, and the following mentoring plan component(s) (ex. Applicant: John Doe, MD, Proposed Mentoring Plan, Career Development Goals, or Research Project Timeline, or Extramural Funding, Manuscript, Meeting Presentation Timeline as appropriate). 

Please provide up to half page statement (in 11-point font) on applicant’s plans for educational development during the award (intention to pursue a Certificate or Master of Science in Clinical Translational Research formerly known as Clinical, Biomedical, and Translational Investigations, or other coursework, tutorials, or training).

Include and describe structured activities, such as coursework or technique workshops as well as specific benchmarks, and anticipated dates of completion.  This portion of the application needs to include didactic courses that will be incorporated into the career development and mentored research experience.  Also, explain how this educational plan will facilitate overall long-term career development goals.

The header should include applicant's name and title of this section (ex. Applicant: John Doe, MD, Proposed Education Plan).

Please provide a separate page for each component stated below. Please upload as a combined single PDF document. Please use 11-point font and add applicant's name in header for all sections below:

a. Personal Statement by the Applicant (up to half page): A personal statement by the applicant describing his/her career goals, future commitment to clinical translational research, and how this research project would help him/her to achieve these goals.  Elaborate on future goals, not on the past. Stress the new, enhanced research skills and knowledge that will be acquired as a result of the proposed award.  Address how this award will allow you to accomplish your career/training goals.  If an applicant has considerable research experience in the same areas as the proposed research, reviewers may find that the program will enhance  their research career.

Please use 11-point font as well as include applicant’s name, title of the section and title of the specific component in the header    (ex. Applicant: John Doe, MD, Proposed Research Plan, Personal Statement by the Applicant).

b. Structured Abstract: The abstract is a summary of the proposed research project.  The following sections must appear as part of  the structured abstract (250 word limit):

• Background: Provide background information on the research topic.
• Research Question/Hypothesis: Concisely state the study hypothesis.
• Design: Describe the study as retrospective or prospective. Identify the study design. Interventional studies should be listed as a randomized clinical trial, non-randomized clinical trial, interventional case series, or interventional case report. Observational studies should be listed as a case control study, cross-sectional study, cohort study, or observational case series. A perspective, meta-analysis, or auto-designation study should be indicated, as appropriate.
• Participants/Animal: State the number of persons/animals and/or the number of controls if a separate control group is included.
• Methods/Approach: Concisely, describe the principal treatment(s), procedure(s), test(s), or observation(s) to be performed in order to answer the research question.
• Main Outcome Measures: Defines the main parameter(s) being measured (e.g., intraocular pressure, vision, electroretinography, inflammation, etc.).
• Innovation: Briefly summarizes the anticipated research results or innovative contributions/impact.

c. Specific Aims (one page using 11-point font, and including applicant's name in the header): State concisely the goals of the  proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology that can be developed to improve health or health care.

d. Research Strategy (no more than two pages using 11-point font, and including applicant's name in the header): Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading (Significance, Innovation, and Approach).

Study details should be cited using the Bibliography and References Cited section and need not be detailed in the Research Strategy.

• Significance/Relevance: Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.  Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.  Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. State the relevance to health problems in general and to health problems in urban settings where relevant.
• Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s). Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.
• Approach: Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.  If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

e. Preliminary Data (up to one page using 11-point font, and including applicant's name in the header): Include relevant  preliminary data (graphs, tables, micrographs, etc.) that support the hypothesis and are in line with the Specific Aims. (Note: The purpose of preliminary data is to demonstrate, where relevant, work that the candidate has already initiated on his/her research    project, but not to demonstrate full competency in the applicants’ research approach. If no preliminary data is available, relevant data from outside sources maybe used for this section.  Please reference outside sources under the cited literature    section of the application).

f. Literature cited: Authors, title, journal, volume, pages, and year. Do not exceed 25 references. Cited Literature must be specifically related to the applicant’s research. Please use 11-point font, and include applicant's name in the header.

NIH Bio Sketch of the applicant (four pages using 11-point font, and including applicant's name in the header): An NIH Biosketch  is a format used by the NIH to collect and document pertinent information about people involved with NIH research. Please refer to the NIH website for formatting, additional information, and samples they provide.

There is no page limit.

Applicant and mentors’ signatures must be obtained to complete the submission process.

Please download the Signature Page (version 5/31/24) and have all required signatures signed. Required signatures:

• Applicant
• Primary Mentor
• Co-mentor and additional co-mentors
• Department or Division Chair

Once signatures have been obtained, upload a PDF copy of the signature page to complete the submission process. Please note digital signature with a time stamp will be accepted if original signature is not obtained. If you are not able to obtain all required signatures on the same page, please combine the various pages into one PDF document.

• Please use an Arial, Helvetica, Palatino Linotype or Georgia typeface, a black font color, and a font size of 11 points or larger. 
• A Symbol font may be used to insert Greek letters or special characters; the font size requirement still applies. 
• A smaller type size is acceptable but it must be in black ink, and readily legible for figures, graphs, diagrams, charts and tables. 
• Use at least one-half inch margins (top, bottom, left, and right) for all pages, including continuation pages. 
• Since a number of reviewers will be reviewing applications as an electronic document and not a paper version, applicants are strongly encouraged to use only a standard, single column format for the text. 
• Avoid using a two column format since it can cause difficulties when reviewing the document electronically. 
• The application must be single-spaced.

Applicants will be able to submit their applications through InfoReady portal, an electronic Grant Application and Tracking Environment. Electronic application portal will be accessible starting June 1, 2024.