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 years of salary support up to $75,000 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 $75,000 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. These expectations must be qualified by the fact that competitive renewal of our funding as part of the CTSI is anticipated in July 2011, and whereas we believe it is unlikely that there will be an interruption of our funding, we cannot guarantee continued support of KL2 scholars after this date.

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. Exceptions to this can be made for institutions that are closely affiliated with CTSI/UCSF, such as the Northern California Kaiser Foundation Research Institute, the Gallo Center, the Gladstone Institute, and Children’s Hospital Oakland Research Institute.

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 program 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 program.

Sources of support for the 75% effort include the CTSI for amounts up to $75,000 per year (plus accompanying benefits), and the department of the K awardee to cover the remainder of the 75% effort (“the salary gap”), as needed. In addition, while federal grants and contracts may not be used for salary support of KL2 scholars, other intramural and non-federal extramural 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 own salary gap.

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 salary support being reduced proportionately. However, devoting less than 75% to career development is rarely desirable, and should be discussed in advance with the KL2 Program Director.

The NIH has a specific policy on receiving concurrent support from an NIH R01 and a K Career Development Award 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 we believe that a secondary degree in a clinical research-related field is an important qualification.

The requirement will normally be met by enrolling in our 2-year Master of Advanced Studies in Clinical Research Degree, or equivalent. Under some circumstances, such as when the Scholar already has an MPH, 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. 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. Within broad limits, tuition, whether at UCSF or elsewhere, is paid for by the program.

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 (generally $25,000 per year).

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

Each scholar will be provided space and a computer at the Department of Epidemiology and Biostatistics Clinical Research Facility at 185 Berry St, China Basin Landing, San Francisco. Scholars may occupy a "hotel" cubicle or office 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 Program, 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 at the site of their clinical research in their department.

In addition to space for the Scholars, the Clinical Research Facility includes the offices of the core faculty (John Boscardin, David Glidden, Amy Markowitz, Charles McCulloch, Tom Mitchell, John Neuhaus, Dennis Osmond, Eric Vittinghoff, and Louise Walter) and the offices of the Director (Steve Hulley), the Associate Directors (Ralph Gonzales and Kirsten Bibbins-Domingo), the Deputy Director (Chris Ireland), the Finance and Technology Coordinator (Shirley Yuen), the Program Assistant (Allison Deneen), 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 are given by faculty and advanced scholars of the CTSI KL2 Program, as well as invited speakers from UCSF and other universities.

• Lunch with Faculty and Scholars. This provides a weekly forum for meeting and networking with other scholars and faculty at China Basin.

• 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 feedback and suggestions on at least one manuscript and one grant.

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.

7. Supporting CTSI Programs

Scholars are expected to contribute to the goals of the CTSI in the UCSF Pathways Program. This includes serving as role models for pre-doctoral PACCTR and Doris Duke fellows and for clinical fellows, and 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-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.

8. Attendance at annual CTSA KL2 meeting

In the spring of their first year, scholars are required to attend the national annual meeting (or a mutually agreed alternative) for clinical research scholars and program directors paid for by the scholars' KL2 travel funds. This provides an opportunity for the scholars to meet colleagues from across the nation and present their work.

9. 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).

Every six months thereafter

• 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 April

• Scholars complete an annual NIH progress report.

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