Paul Calabresi Clinical Scholars Award

• 2 years of mentored support, additional years depending on productivity, need and available funds with a maximum of 4 years ​
• Up to $100,000 salary plus fringe benefits per annum 
• $30,000 per annum research and educational costs 
• Structured mentoring and defined training program with primary mentor in the scholar's discipline and two or more additional mentors. 
• Scheduled formal evaluation of progress and feedback from Advisory Committee

Eligible Scholars are clinical oncologists (M.D., D.O., Ph.D. R.N., Pharm. D. or equivalent) who have completed their clinical training, and Ph.D.’s in a scientific discipline who are pursuing translational human-oriented cancer research and who have completed at least two years of postdoctoral training.  The level of faculty appointment is determined by UCD-AMC Human Resources policy.  Strategies for recruitment of candidates for this PCACOR program (now in its 17th year of funding) focus on junior faculty in oncology disciplines who have already received appointments at UCD-AMC.  Expansion of the program pool to include senior fellows in clinical disciplines as well as basic scientists has permitted expansion of recruitment efforts, but awards are made when Scholars begin their junior faculty status.

• Scholars will be recruited from all areas of Oncology (e.g., medical, surgical, pediatric, radiation, gynecologic, epidemiology, as well as other basic and clinical disciplines pursuing translational cancer research). 
• NIH requires that candidates must be U.S. citizens, nationals or permanent resident aliens.  
• The recruitment pool will target junior faculty who are early (within the first five years) in an academic career focused on Clinical Oncology Research.  Women and underrepresented minorities are encouraged to apply.
• Applicants can apply up to 6 months prior to completion of their clinical training or postdoc.

Candidate’s Background (one page)

• Describe the candidate's commitment to an academic career in Patient-Oriented Research (POR).  Describe all of the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career award. If the candidate is already faculty, describe how their effort will change (if needed to) as a PCACO Scholar to accommodate the effort for the award. (i.e., Dr. Moo currently sees patients 2.5 days a week in clinic and this will be reduced to 1.5 days a week on the grant, or similar). Candidates with existing protected time that will be maintained should be described in detail. 

• Present evidence of the candidate's ability to interact and collaborate with other scientists.

• Describe prior training and how it relates to the objectives and long-term career plans of the candidate.

• Describe the candidate's research efforts to this point in their research career, including any publications, prior research interests and experience.

• Provide evidence of the candidate's potential to develop into an independent investigator.

• If applicable, describe the candidate's prior clinical trials research efforts, prior research interests and experience. If these are extensive, describe what is different about the research to be conducted next that merits ongoing need for mentored support.

Career Goals and Objectives (one page or less)

• Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) justifies the need for further career development to become an independent investigator. The PCACO scholar is expected to use their 2 years of support to bridge to the next step of their research plan and independence. This will vary depending on the candidate. A more scientifically experienced scholar may propose an R01 as the next step of their career.  An earlier career candidate may propose applying for a K23 or similar national level career development award as the next step of their career.

• The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

Candidate’s Plan for Career Development/Training Activities During Award Period (one page)

• The candidate and the mentor or mentoring team are jointly responsible for the preparation of the career development plan.  A career development timeline is often helpful.

• The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals. A table is often a good choice to illustrate the career development plan over the 2 years of the award by skill needed, mentor/mentor committee member to support, coursework or research skill to be mastered.

• Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the K12 award.  Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

Research Strategy (Two pages or less)

• The PCACO Scholar candidate will propose a plan of research that can be accomplished within two years.

• Provide a hypothesis and specific aims for the research plan proposed for the 2 years; include the novelty, significance, creativity, approach, and the feasibility of the candidate to carry out the research.

• The application must also describe the relationship between the mentor's ongoing research and the candidate's proposed research plan and how the candidate will move to independence from the mentor over time.

• While the focus of the K12 award is on POR, directly related translational laboratory research may be proposed in the application, if there is direct human subjects contact/connection proposed in the research or career development plan. Analysis of data from samples derived by others with no direct human subjects contact during the award time is not eligible.

• Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions. Inclusion of a biostatistician or bioinformatics/data analyst to the mentorship committee is needed for projects that will be heavily data driven to be considered feasible unless the candidate has their own extensive background in this area.

• If proposing an ancillary clinical trial, provide a brief description of its relationship to the larger clinical trial.

• If proposing a clinical trial, describe how the two years will be used to set up the study and what are the plans for continuance of the trial if the timeline of completion will bridge to the next phase of the Scholar’s career development.

• If proposing a 1-2 year feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the career development and future research projects including planning and preliminary data for future, larger scale clinical trials.

• Provide a timeline for the proposed clinical trial, feasibility or ancillary study, including potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study). Describe how the proposed clinical trial or ancillary study will test the safety, efficacy or effectiveness of an intervention that could lead to a larger study that could change clinical practice, community behaviors or health care policy. (This would not apply to a feasibility study).

Plan for Mentor/Co-mentor(s) and mentorship committee: (one page)

• The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the proposed program.  The candidate may also nominate co-mentors as appropriate to the goals of the program. 

• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.

• The primary mentor or co-mentors should provide a letter of support that includes a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) to the career development program and related career development activities.

• A strong letter from the mentor/co-mentors will include a statement providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate's research, publications, and progression towards independence.

• The primary mentor/co-mentors must agree to attend regular meetings with the Scholar and participate in a 6-month full committee reviews with their Scholar, the mentoring team and the PCACO leaders. The mentor/co-mentors are also expected to participate in the activities of the PCACO K12 Award (~5 meetings per year -4 scholar based interactive meetings and one national annual meeting during the 2-year award period) and will be required to write and provide annual evaluations of the candidate's progress as required in the annual progress report.

• The mentor or mentoring team should be a complementary but not overlapping team of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help them to meet timelines.

Biosketch

• Provide NIH Common Form style biosketch.  Follow the format of the NIH regarding the common form biosketch requirements through SciENcv (See notice NOT-OD-26-018)

Letters of Support

• Institutional Commitment to the Candidate’s Research Career Development (a letter from the department or division head or cancer center leader who is the senior direct report for the candidate).

• The sponsoring division, department or program must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.

• Provide assurances that the candidate will devote the required effort to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.

• Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.

• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

• Mentor Letters of Support: Provide at least 2 additional letters of support: One should be from the primary mentor and at least one from a co-mentor or equivalent. 

The following is the list of the required core activities for clinician and basic scientist scholars including the expected time of completion:

During the first two years in the training program, Paul Calabresi Scholars are expected to reach certain milestones. Scholars should use the following timeline to help plan there first years in the training program.

Year 1:

Year 2: