1. Duration 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 at $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 at $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 it is unlikely that there will be an interruption of our funding, we cannot guarantee it.

2. Professional Effort Devoted to the Program

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 research, clinical and teaching activities if these activities are consistent with the proposed goals of the KL2 program.

3. Didactic Training in Clinical and Translational Research

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 strongly 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 CTSA 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 that is due by April 6, 2009. 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 in excess of the allowable costs of 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 Scholars' research. Lead mentors will provide guidance to the Scholar 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 due in August and updated in January and August each year. Mentors are also required to meet with the CTSI KL2 principal advisor of the scholar, and to participate in efforts to evaluate and improve mentoring at UCSF. 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 attractive and 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, Tom Novotny, Dennis Osmond, Eric Vittinghoff, and Louise Walter) and the offices of the Director (Steve Hulley), the Associate Director (Ralph Gonzales), the Assistant Director (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 informally discuss issues regarding their research with faculty or arrange meetings if desired.

6. Attendance at Seminars, Annual Retreat, Core Courses, Other Activities

CTSI KL2 Scholars are required to attend weekly work-in-progress seminars held on Friday mornings at our China Basin facility. The seminars serve as the glue of the program, an opportunity for scholars to meet regularly, review and contribute to each other's work and obtain expert methodologic advice, as well as be exposed to high quality clinical researchers from a variety of disciplines who will lead guest lectures throughout the year. These seminars will address a variety of topics, in keeping with our multidisciplinary mission, but will focus on methodologic issues as the unifying theme. Each scholar is expected to lead 4-6 work-in-progress discussions each year during their first 2 years, and in later years to lead methodologic seminars.

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.

In addition, there may be special activities scheduled throughout the year such as career development forums and opportunities to observe IRB proceedings. Scholars are also asked to participate as teachers and mentors in the training and career development of pre- and post-doctoral students. These activities are in addition to the coursework required by the Master's Degree in Clinical Research.

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 other UCSF populations. 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 TICR course (for example, leading a section in Designing Clinical Research). This expectation 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

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, which provides an opportunity for the scholars to meet their Scholar colleagues from across the nation and present their work. These meetings will usually take place in Washington, D.C. in late March.

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

By the middle of the 3rd Year (or end of the 3rd 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

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

January

• Scholars update their career development plan for review with their mentors and with their KL2 Advisor. The mentors also meet with the KL2 Advisor in person or by telephone, 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.

March

• Scholars complete an annual NIH progress report.

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