CTSI KL2 Scholars Program

Overview

The UCSF Clinical and Translational Science Institute Career Development Program (CTSI KL2) is supported by the CTSI and by the four UCSF Schools. This year 5-6 Scholars at the faculty level will be selected for a career development award to begin July 1, 2014. Scholars will receive 4-5 years (depending on level of training upon entering the program) of salary support up to $85,000 per year for 75% effort to pursue multidisciplinary clinical research with training and mentoring.

Clinical research is defined broadly as everything but pure bench science, and the program emphasizes T1 translational research (basic science of humans to clinical application studies) and T2 translational research (clinical application to improved health in the population). The program includes a master's degree in clinical research for those who do not have such training, a supportive environment, funds for research, tuition, and travel of at least $22,000 per year, weekly work-in-progress and methodology seminars, and access to core faculty who provide expertise and guidance in research design, measurement and questionnaire design, study coordination, data management, biostatistical analysis, publishing and presenting research, and manuscript and grant writing.

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Goal

The goal is to increase the number and quality of outstanding clinical investigators skilled at leading multidisciplinary research teams. The overarching goal is to promote clinical and translational investigation that will have an important impact on the health of the public.

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Eligibility

Candidates for CTSI KL2 awards must:

  • Be a U.S. Citizen or Permanent Resident; individuals on temporary or student visas are not eligible
  • Possess a doctoral-level degree (MD, PhD, Pharm D, DDS, etc.) and be a junior faculty member at UCSF in any series above the clinical instructor level (as of July 1, 2014)
  • Commit 75% of professional effort to the program (surgeons and some other specialists with large clinical burdens 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 (K23, K08, K01, etc.), or equivalent non-PHS peer reviewed research grant that is over $100,000 in direct costs per year. May have had support on a NRSA grant (F or T) or have been PI of an NIH small grant (R03 or R21). (Note: Candidates may have had previous support on a K-12 award, but the CTSI KL2 cannot extend total K support beyond 5 years.)

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Scholar Selection Criteria

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; 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 plan 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

Individuals from underrepresented ethnic minority groups are encouraged to apply, and special consideration will be given to individuals in departments and disciplines that have traditionally been under-represented in clinical research.

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Program Requirements

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 who enter the program with at least one year of advanced training in clinical research (Advanced Training in Clinical Research (ATCR) Certificate or MAS Degree from UCSF, or equivalent) will receive 4 (rather than 5) years of salary support up to $85,000 per year. Scholars who have not had advanced training in clinical research will obtain the Master's degree (or under some circumstances the ATCR Certificate) as a KL2 Scholar and will receive 5 years of salary support up to $85,000 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. Note also that the CTSI KL2 grant period ends 6/30/16 and funding beyond that date cannot be guaranteed.

    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 the 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 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 $85,000 per year (plus accompanying benefits), and the department of the KL2 scholar for any remaining gap between $85,000 and 75% of the salary of the scholar (the salary gap), as well as the remaining 25% of the scholar's salary. Note that NIH rules prohibit KL2 scholars from receiving salary support from other federal grants and contracts (except in the final two years of K funding, as noted below); however, other intramural and non-federal extramural grant sources may be used for this purpose. 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.

    Surgeons and some other specialists with large clinical burdens 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 award Director.

    The NIH 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.

    The training requirement will normally be met by enrolling in our 2-year Master of Advanced Study in Clinical Research Degree, or equivalent. Under some circumstances, such as when the Scholar already has an MPH or for those with MD, PhD training, the 1-year ATCR Certificate program may be a suitable alternative. Scholars who already have two years of advanced training in clinical research may take individual courses to complete gaps in or update previous training. 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 KL2 advisors. Tuition may be paid for from the KL2 scholar's funds.

    Individuals who are selected as CTSI KL2 Scholars and who will obtain a Master's degree as part of their training plan must complete a separate application for a Master's Degree in Clinical Research. Information and application materials are available on the Master's Program website.

  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 participate in at least one of the Scholar's Work-in-Progress seminars each year, and to work with the scholar on a Career Development Plan that is updated every six months. Mentors are also required to meet with the KL2 principal advisor of the scholar, who serves as an ongoing career mentor. Each scholar is also expected to meet periodically with her/his division head/department chair who will oversee the scholar's departmental interactions and academic advancement.

    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
    KL2 Scholars will have space and access to the wireless network at the Department of Epidemiology and Biostatistics (DEB) Clinical Research Facility at 185 Berry St, China Basin Landing, San Francisco. Note that the DEB is scheduled to move to Mission Hall on the Mission Bay Campus in September 2014. Scholars may occupy a "hotel" space for the days they wish to work at the facility. Having functional space and dedicated personnel for the Scholars embedded in a much larger set of clinical research activities and support technologies is an important strength of the CTSI KL2 award, one that will optimize the scholars' acquisition of skills in research methodology and ability to build and lead interdisciplinary teams. Most scholars will also have an office, computer, and administrative support in their department.

    In addition to space for the Scholars, the Clinical Research Facility includes the offices of the core faculty (John Boscardin, Richard Grant, Amy Markowitz, Charles McCulloch, Tom Mitchell, John Neuhaus, Mark Pletcher, Steve Shiboski, Saunak Sen) and the offices of the Director (Kirsten Bibbins-Domingo), the Co- Director (Louise Walter), the Deputy Director (Chris Ireland), the Finance and Technology Coordinator (Shirley Yuen), the TICR Program Director (Jeff Martin), and other relevant staff.

    We consider the time spent in physical proximity to each other and to clinical research expertise to be extremely important for forming a support group during a Scholar's first 1-2 years in the program. For this reason, scholars are encouraged to spend as much time as possible at the clinical research facility and will be required to spend at least one morning per week in residence, on Fridays. Core faculty will also be in residence on Fridays to make it easy for scholars to discuss issues regarding their research with faculty or arrange meetings if desired.

  6. Key Program Elements
  • Weekly Works-in-Progress Seminar: Fridays 9-10:45 AM. This serves as the core conference attended by the K-scholars, in groups of 10, with 2 experienced clinical research faculty: an epidemiologist 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 5-6 weeks. The frequency of works-in-progress meetings declines in subsequent years.
  • Weekly Methodology Seminars: Fridays 11:00 AM-12:00 PM. These seminars, on a wide variety of topics relevant to research methods and career development, are given by faculty and advanced scholars of the CTSI KL2 award, as well as invited speakers from UCSF and other universities.
  • Lunch with Faculty and Scholars. This provides an informal forum for meeting and networking with other KL2 scholars and faculty.
  • Expert Advice and Guidance. Each CTSI K scholar will have access to epidemiologic and biostatistical advice and the opportunity to receive extensive one-on-one tutorials on at least one manuscript and one R01 grant proposal.

In July, there will be a retreat to kick off the program and provide the opportunity for old and new scholars to get to know the program faculty and staff, and each other.

  1. Supporting CTSI Programs
    Scholars are expected to contribute to the goals of the CTSI teaching clinical and translational science methods to others in the K Program and in their home departments. As part of this, scholars are expected to participate at least once during their tenure in the CTSI K Program as an instructor in a CTSI or TICR-sponsored course (for example, leading a section in Designing Clinical Research).

    This expectation is in addition to the teaching required by the Master's Degree in Clinical Research, and is designed in part to enable the Program to respond to the growing need for what we teach and in part to add a relevant element to the career development of scholars. There is no better way to enhance expertise in the methods of clinical and translational science than to teach them.

  2. Attendance at annual Translational Science meeting
    In April of their first year, scholars are required to attend the Translational Science Meeting, the national annual meeting for clinical research scholars and program directors paid for by the scholars' funds. This provides an opportunity for the scholars to meet colleagues from across the nation and present their work.

  3. 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 2nd year, and each year thereafter:

    • 3 peer-reviewed publications submitted, two of these as first or last author and two representing original research
    • One multidisciplinary extramural grant of any size submitted (typically R21, R03, or other federal, state, foundation, industry, or intramural grant).

    By the end of the 3rd Year (or middle of the 4th year for scholars taking ATCR, Masters, other full time course work in the first year):

    • One multidisciplinary, R01 grant (or equivalent) submitted.

    Scholar Performance Reviews

    August of the first year

    • Scholars, in consultation with their mentors, create a "career development plan" for review by their "K Advisor" (the CTSI KL2 Director or his designee).

    Six months later and then annually

    • Scholars update their career development plan for review with their mentors and with their K Advisor, and these assessments are reviewed at a KL2 faculty meeting. The meetings are the main opportunity to identify actions the scholar needs to take to assure continuation in the program the following July.

    Each year in March

    • Scholars complete an annual NIH progress report.

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    Application Advice

    We recommend that individuals interested in learning about how to write successful research or career development award applications review the course Grant Writing for Mentored Career Development Awards, a self-paced online course prepared by Tom Mitchell, our resident expert.

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    Application

    Before submission, candidates should check with their department chairs to ensure that the department will provide any salary in excess of $85,000 per year that is needed to cover their 75% protected time for training and research, as well as salary for the 25% effort not covered by the CTSI KL2 grant. Note that these funds may not be derived from Public Health Service fund sources. 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 by providing $17,000 per scholar per year to the CTSI. The School of Medicine has committed to this, and candidates from the other schools are advised to check with their Dean's Office prior to submitting an application.

    The UCSF KL2 Award has an electronic submission process that requires direct data entry by the applicant, as well as uploading PDF formatted documents. The KL2 application requires many of the same elements as the NIH K 23 Award in addition to a few KL2 specific requirements (table below).

    Applicants must use the NIH instructions and format for the K23 elements, following the instructions here. Questions about these instructions should be referred to the official in charge of K awards at an NIH institute appropriate to the candidate's specialty. For questions about the KL2 electronic submission process and KL2 specific elements contact Chris Ireland at cireland@psg.ucsf.edu.

    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 your Candidate Statement. For resubmissions the page limit for the Candidate Statement is increased by 1/2 page to allow space for this additional information.

    Note on international research: If you are planning to conduct international research as part of your KL2 research, please contact Kirsten Bibbins-Domingo, KL2 Program Director, before completing an application. NIH has very stringent rules regarding KL2 scholars involvement in international research.

    Note on clinical trials: If you are planning to conduct a clinical trial, please contact Kirsten Bibbins-Domingo. 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, February 10, 2014

    KL2 Specific Information Type of Entry
    KL2 Applicant Contact Information Direct entry
    KL2 Applicant Demographics Direct entry
    KL2 Mentor(s) Contact Information Direct entry
    KL2 Candidate Statement (2 pg) KL2 form (Word doc)
    KL2 Lead Mentor Statement (1 pg) KL2 form (Word doc)
    KL2 Co-Mentor Statement (1 pg) KL2 form (Word doc)
    KL2 Dept Chair Statement (1 pg) KL2 form (Word doc)
    NIH K23 APPLICATION ELEMENTS  
    Project Summary/Abstract PDF attachment
    Candidate’s NIH Biosketch PDF attachment
    Lead Mentor's Biosketch PDF attachment
    * Candidate Information PDF attachment
    Specific Aims (1 pg) PDF attachment
    * Research Strategy PDF attachment
    References (Bibliographic) PDF attachment
    Protection of Human Subjects PDF attachment

    * K23 Candidate Information and K23 Research Strategy should not exceed 12 pages.

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    Important Notes on the Electronic Submission

    • Once you begin the electronic submission you must submit it within 7 days (a limit of the forms software). Therefore, we highly recommended that you prepare all of the required elements in advance and complete the electronic submission in one sitting (or over a couple of days so you can go back and review what youve included before you press submit).
    • Review the PDF version of the complete application so that you know exactly what is required.
    • Download the KL2 specific forms including the Candidates Statement, Lead Mentor, Co-Mentor and Department Chair/Division Chief Statements from the table above. Ask your mentors and Chair to complete and sign these and return to you. Prepare the 2 page Candidates Statement. Create separate PDF versions of these forms to upload to the KL2 application.
    • Prepare all required elements of the K23 application as indicated in the table above. Create separate PDFs of the individual required elements to upload to the KL2 application.

    Candidates who are interested in applying for a UCSF KL2 should email a one sentence notice of intent to Chris Ireland at cireland@psg.ucsf.edu. The purpose is to let us know how many applications to expect so that we can arrange the review process. The notice of intent is due by January 6, 2014.

    KL2 Online Application

    Online Application

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    Receipt, Review, Award Schedule

    Call for Applications/Application format available November 2013
    Notice of Intent due January 6, 2014
    KL2 Applications due February 10, 2014
    Interviews of selected applicants February 1, 2014 - March 14, 2014
    Initial notification of awards April 8, 2014
    Master's Applications due
    (special late date for KL2 Awardees only)
    April 16, 2014
    Appointment start date July 1, 2014

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    Leadership

    Director: Kirsten Bibbins-Domingo MD, PhD, MAS
    Co-Director: Louise Walter MD
    Deputy Director: Chris Ireland MPH
    Finance and Technology Coordinator: Shirley Yuen MPH
    For information email: cireland@psg.ucsf.edu

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