KL2 Scholars Program

Candidates for CTSI KL2 awards must:

• Be a U.S. citizen or permanent resident; individuals on temporary or student visas are not eligible
• Have a primary full-time paid appointment as a junior faculty member at UCSF in any series above the clinical instructor level (as of July 1, 2024)
• Commit 75% of professional effort to the program (surgeons and some other procedure-oriented specialists may request a lower level of effort, but in no case lower than 50%) 
• Not be or have been a principal investigator on an NIH R01, or project leader on a subproject of a Program Project (P01), Center (P50, P60, U54), mentored career development grant (K12, K23, K08, K01, VA Career Development Awards, etc.), or equivalent non-PHS peer-reviewed research grant that is over $100,000 in direct costs per year. PIs of an NIH small grant (R03 or R21) are eligible, and previous support on a NRSA grant (F or T) is allowed.
• Not be a current or past recipient of a UCSF K12 award.
• Not be a current or past participant in the CTSI K Scholars Program (with your own Career Development Award).
• Have not submitted an NIH K individual (K23/K08/K01/K99/etc.) application in the current January through March cycle (Cycle 1). If you have submitted an NIH K award during another cycle and are offered a KL2 position you will need to withdraw any other pending NIH K applications.
• The KL2 is not approved for activity defined as a foreign component in the NIH Grants Policy Statement.  Exceptions would be if the scholar is working directly under an NIH parent grant that has an established research infrastructure. Prior approval from the NCATS program officer must be obtained before the KL2 can be officially awarded to the scholar.

Note that UCSF K12 recipients, NIH K awardees and VA Career Development Awardees are encouraged to participate in the CTSI K Scholars Program by applying with an outside award.

A campus-wide selection committee will review the scholar applications following the model of the NIH peer review process. Selection criteria will focus on the strengths and potential of the candidate to become a leading multidisciplinary clinical investigator judged in five major domains:

1. Track record: Creativity of the candidate and potential to lead excellent multidisciplinary research judging by track record in some or all of the following: areas of expertise and prior training; first authored publications; funded grants
2. Research plan: Scientific value, potential clinical importance and feasibility of the written multidisciplinary research plan
3. Training plan: Quality, appropriateness and multidisciplinary complementarity of the proposed mentors, and scholar-specific plans for additional didactic and other training at UCSF or elsewhere
4. Resources: Tangible commitment and resources provided by the home department/ORU, and suitability of the available clinical and laboratory infrastructure and multidisciplinary team
5. Career potential: Global assessment of the likelihood that the candidate will develop a career as an outstanding investigator who will lead multidisciplinary teams and have an important impact on health 

Minimum eligibility requirements to apply for a CTSI KL2 Award include having 1) at least two first-authored peer-reviewed publications in the general topic area of the KL2 proposal; 2) mentors from more than one discipline; and 3) clear commitment and resources from the home department/ORU.

Individuals from historically excluded and underrepresented in medicine groups are encouraged to apply, and special consideration will be given to individuals in departments and disciplines that have traditionally been underrepresented in clinical research.

All KL2 recipients will become part of the CTSI K Scholars Program. The specific requirements of the KL2 award, as well as the general requirements of the K Scholars Program, are detailed below:

1. Duration and Transferability of the Award
   CTSI KL2 Scholars will receive three years* of salary support of up to $120,000 per year. Each year of funding is contingent on satisfactory participation in the CTSI KL2 activities and progress toward the scholar's individual career goals, and continued support from the scholar's mentors and department.
   
   This is an institutional career development award granted to UCSF, and it is non-transferable; scholars who leave UCSF will not be able to continue receiving KL2 funding from UCSF.
    
2. Professional Effort Devoted to the Program and Source of Funding
   Generally 75% of a scholar's full-time professional effort must be devoted to the KL2 award for training and clinical research activities. The 75% effort is based on the entire amount of time worked in a typical week and should include proportionate amounts of normal weekday time. The remaining 25% effort can be divided among other research, clinical, administrative and teaching activities that are consistent with the proposed goals of the KL2 award.
   
   Sources of support for the 75% KL2 effort include the CTSI KL2 grant for amounts up to $120,000 per year (plus accompanying benefits), and the department of the KL2 scholar for any remaining gap. Note that the "salary gap" or salary supplementation to cover 75% of the scholar salary may not come from federal fund sources. Scholars who acquire non-federal sources of funds that are appropriate for this use, such as foundation career development grants, may reasonably be expected by their department to allocate part of the award to help cover their salary gaps. The remaining 25% of the scholar's effort may be covered by a variety of sources, including federal grants that comply with NIH policy.
   
   Surgeons and some other procedure-oriented specialists may request a level of effort that is lower than 75% (but in no case lower than 50%), the level of CTSI KL2 salary support being reduced proportionately. However, devoting less than 75% to career development is rarely desirable and must be discussed in advance with the KL2 leadership.
   
   The NIH also has a specific policy on receiving concurrent support as a PI of an NIH R01 and a K Career Development Award in the last two years of a K, which can be reviewed here.
    
3. Didactic Training in Clinical and Translational Research
   Formal training in a rigorous and comprehensive clinical research program is imperative for establishing independence as a clinical investigator and a secondary degree in a clinical research-related field is an important attribute.
   
   Productive participation in the Program requires a solid didactic foundation in research methodology and statistical analytics. The training requirement will normally be met by prior completion of or concurrent enrollment in the one-year ATCR Certificate Program. Concurrent enrollment in the two-year Master's Degree in Clinical Research is probably not feasible during a 3-year career development award. Scholars who already have formal advanced training in clinical research (e.g., MPH, MAS, PhD) may take individual courses to complete gaps in or update previous training and should be described in the KL2 application. KL2 scholars will be required to take Responsible Conduct of Research (EPI 201) during their KL2 award period, ideally upon starting the program in July if they’ve not taken the UCSF course in the past two years. Those who have not taken our cornerstone Designing Clinical Research course (EPI 202) will find it an excellent and relevant review.
   
   In addition to taking TICR courses as noted above, we recommend that all scholars enroll in other courses and workshops in disciplines relevant to their career development plans at UCSF and at other institutions; these should be planned in discussions with mentors and K advisors. Tuition may be paid for from the KL2 scholar's research funds.
    
4. Mentors
   Developing a successful clinical research career requires strong relationships with mentors and a research team. Each scholar must have a lead mentor and at least one other mentor from a different discipline. Mentors should have sufficient independent research support to cover the costs of the proposed research project that exceed the scholar research funds provided by the KL2.
   
   Lead mentors will have overall responsibility for helping scholars develop creative and independent careers in research. In addition to being an expert in the scientific area the scholar has chosen to pursue, a lead mentor must be familiar with faculty, resources and databases at UCSF, and have resources and research staff that can support the scholar's research. Lead mentors will provide guidance to assure that projects are moving satisfactorily on the path to presentations, publications and grant applications, and they will provide advice about career directions, national networking and academic promotion. They will also help to assure that 75% of the scholar's total work week is protected from clinical and administrative duties and fully available for training and research. Co-mentors will be responsible for working with the lead mentor on these responsibilities and will provide guidance in one or more complementary areas of expertise.
   
   Scholars will meet frequently with the lead mentor, both individually and in conjunction with other members of the research team. Scholars will also meet regularly with their co-mentors, and at least twice a year with all their mentors as a group. Mentors are encouraged to work with the scholar on a Career Development Plan (CDP) that is updated every six months. Each scholar is also expected to meet periodically with her or his division head or department chair who will oversee the scholar's departmental interactions and academic advancement.
   
   KL2 Selection Committee members may also serve as mentors, but during the selection of the candidate, these individuals will be excused from the discussion and vote.
    
5. Clinical Research Facility In 2023-24, the K Program conducts in-person activities once per month at Mission Hall. All other activities take place by Zoom. The program will frequently reassess the virtual environment and ask scholars for feedback about increasing in-person activities. Scholars are welcome to use the focus and huddle rooms in the department of epidemiology and biostatistics suite on Fridays. It is expected that scholars will also have an office, computer and administrative support in their primary department.
    

Key Program Elements

Weekly Methodology Seminars: Fridays 9:10-10 AM. These seminars, on a wide variety of topics relevant to research methods and career development, are given by faculty and invited speakers from UCSF and other universities.

Weekly Works-in-Progress Seminar: Fridays 10:10-11:45 AM. This serves as the core conference attended by the K-scholars, in groups of about 12, with at least two experienced clinical research faculty, including a clinical researcher and a biostatistician. Scholars present and discuss their research works-in-progress each week in a supportive and constructive environment, considering study and grant ideas and designs, implementation issues, analytical quandaries, research results, and drafts of grant applications and manuscripts. The work of two scholars is reviewed each week in the first year, with each scholar presenting about every five to six weeks. The frequency of works-in-progress meetings declines in subsequent years.

Expert Advice and Guidance: Each CTSI K scholar will be assigned a K faculty advisor and a K faculty biostatistician. The K faculty advisor is an important source of career guidance outside your home department. The K faculty biostatistician provides biostatistical advice on your research, a service that most scholars find invaluable. In addition, scholars have the opportunity to work one-on-one with our manuscript writing coach, Amy Markowitz, and our grant writing expert, Judy Hahn, on preparing manuscripts and grants.

In July or August, there is a retreat to kick off the program and provide the opportunity for current and new scholars to get to know the program faculty and staff, and each other. This is an in-person overnight retreat at an events facility in the greater Bay Area. Sites have included the Bodega Bay Lodge and Costanoa.
 

Scholar career development plans, progress reports, and performance feedback

Scholar milestones: Since our shared goal is for scholars to become independently funded by the end of their K award period (or earlier), we set out these general guidelines for scholars to consider:

By the end of the second year:

• KL2 Scholars are strongly encouraged to submit an individual K award application (K23, etc.) that will replace the KL2, extending K funding and offering the advantages of being a PI on a grant from the NIH institute of choice.
• Three peer-reviewed publications submitted, two of these as first or last author and two representing original research.

By the end of the third year:

• Six peer-reviewed publications
• Develop Specific Aims for an R01 grant (or equivalent)

Scholar Performance Reviews

October of the first year:

• Scholars, in consultation with their mentors, create a career development plan for review by their K Advisor.

Six months later and then annually:

• Scholars update their career development plan for review with their mentors and with their K Advisor.
• Scholars complete an annual individual NIH progress report. 

Before submission, candidates should check with their department chairs to ensure that the department will provide salary supplementation in excess of $120,000 per year that is needed to cover their 75% protected time for training and research. According to the provisions in our CTSI grant, each of the four UCSF schools is required to share in the cost of providing training and infrastructure to KL2 scholars.
 

Note on resubmissions: If this is a resubmission, please address the reviewer comments and highlight your accomplishments and development since the previous application (e.g., enhanced training, mentors, tangible resources, track record, changes in research plan) in the Candidate Statement (an additional half-page is allowed for responses to reviewer comments).
 

Note on clinical trials: KL2 scholars may not conduct clinical trials beyond the end of phase IIA. A phase IIA clinical trial is a pilot study to evaluate the efficacy and safety of an intervention in patients with the disease or condition to be treated, diagnosed or prevented. These studies may focus on participant population characteristics, dose response, dose frequency or other characteristics related to safety or efficacy. Phase IIA trials are not considered pivotal trials of efficacy.

Required Elements for KL2 Application

Notice of Intent to Deadline: Monday, January 8, 2024 [send email to Gianna Guerrero indicating intent to apply and include full name, degrees held, school, department, division, and if you are resubmitting (this is not binding but helps us plan)]
 

Application Deadline: Monday, February 5, 2024, 6 PM

Please have the documents listed below ready to upload to the Application Form. Convert any Word documents to PDF. Please bundle the PDFs into two PDFs: one for the KL2 specific information and the other for the K23 information.

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Application Form

Receipt, Review, Award Schedule

Program Director: Urmimala Sarkar, MD

Clinical and Translational Science Training (CTST) Director: Alka Kanaya, MD

Associate Directors: Chuck McCulloch, PhD and Louise Walter, MD

Senior Program Manager: Madeline Mann 
Program Coordinator: Gianna Guerrero
Finance Manager: Shirley Yuen, MPH