COM Clinician Scientist K12 Program

COM Clinician Scientist K12 Program SCTR Principal Investigator: Kathleen T. Brady MD, PhD K12 Program Director: Marc Chimowitz MB ChB TEACH Program Director: Perry Halushka MD, PhD SCTR Project Director: Randal Davis For more information email Rebecca Barry: barryr@musc.edu KEY DATES Call for Applications February 24, 2014 Biostatistics Consultation March 14, 2014 final day to submit a request* K12 Applications Due April 2, 2014 - Noon Appointment Start Date July 1, 2014 KEY INFORMATION Number of Slots: 2 Term: 2 years, with the option of a 3rd Award: 40% salary support (subject to the NIH salary cap), $5,000 towards annual project budget per year. Departmental/Division Match: $15,000 in project funds per year; 60% remaining effort, plus over-the-nih-cap costs for the K12dedicated 40% (requires a signed commitment letter from the department/division head) Target Candidates: College of Medicine faculty whose workload would preclude them from participating in the regular SCTR KL2 program due to the 75% effort requirement. Apply via the SCTR website http://sctr.musc.edu/index.php/education/k12 OVERVIEW The SCTR Institute and MUSC College of Medicine announce opportunities for a cohort of institutionally - funded K12 Mentored Career Development Scholars in clinical and translational science. This K12 program supports the career development of scholars holding a research or health professional doctoral degree or its equivalent. The goal of the program is to foster the discipline of clinical research and by increasing clinical research capacity to expedite clinical and translational research. The K12 program will accomplish this through a mentored program bridging clinical training with research independence. SCTR K12 CLINICIAN SCIENTIST PROGRAM 1

This year, two Scholars at the faculty level will be selected for career development awards to begin July 1, 2014. The Scholar will receive up to three years (through June 30, 2017) of salary support at 40% effort (subject to NIH salary caps) per year (see Salary & Time Commitment under Eligibility) to pursue multidisciplinary clinical & translational research with training and mentoring. The Scholars department or division will be responsible for paying over-the-nihsalary-cap costs, as well as the remaining 60% effort. The Scholar will also receive an annual supply budget of $5,000 to purchase research supplies and small equipment, and a department/division match of $15,000 is required (for a combined total of $20,000). Clinical research is defined broadly as everything but pure bench science, and includes translational research, patient-oriented research, clinical trials, epidemiologic research, outcomes research, and community-based participatory research. The program includes a supportive environment, start-up research funds, 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, grant writing, and a training component which the applicants must develop specific to their clinical and translational training goals. ELIGIBILITY Junior faculty and senior fellows pending faculty appointment with a doctorate who are committed to a career in clinical research. Scholars are scientists with doctoral-level professional degrees who represent a broad range of disciplines, professions, specialties and sub-specialties and who can develop into the future leaders in all areas of clinical research. Examples include both clinical doctoral degrees (e.g., MD, DrPH, DPT, DO, DDS, DMD, DVM, PharmD) and non-clinical doctoral degrees (e.g., PhD, ScD). Scholar positions are quite distinct from clinical fellowships. Junior faculty includes anyone at the Instructor or Assistant Professor level that meets the other eligibility requirements for prior research experience, citizenship, education/degree, and clinical certification (if required). Salary & Time Commitment. 40% effort of a Scholar's full-time professional effort must be devoted to the K12 program for the training and clinical research activities, subject to the NIH salary cap. The 40% effort is based on the entire amount of time worked in a typical week, and should be proportionate. The remaining 60% effort can be divided among other research, clinical and teaching activities if these activities are consistent with the proposed goals of the K12 program. Special permission must be obtained for eligible faculty with Veterans Affairs (VA) appointments. Candidates must provide a justification as to the barriers of participating in the SCTR KL2 program, which requires 75% effort. Citizenship. Candidates must be U.S. citizens or non-citizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Individuals on temporary or student visas are not eligible for this program. Prior research experience. Candidates may not be or have been a Principal Investigator on an R01, R29, or a subproject of a Program Project (P01), Center (P50, P60, U54), mentored career development (K-series) grants, or other equivalent research grant awards. However, candidates for this program can be (or have been) a Principal Investigator on an R03 or an R21 award. (K12 Clinician Scientist can apply for K23 support and if successful move from one mechanism to the other.) SCTR K12 CLINICIAN SCIENTIST PROGRAM 2

SCHOLAR SELECTION CRITERIA The campus-wide Multidisciplinary K12 Advisory Committee will review the scholar applications. Selection criteria will focus on the strengths and potential of the candidate to become a leading independent multidisciplinary clinical investigator judged in five major domains: Track Record: Creativity of the candidate and potential to conduct and/or lead clinical and translational research judging by track record in some or all of the following: areas of expertise and prior training; publications; or written product attached to the application. Research Plan: Scientific value, potential clinical importance, and feasibility of the written multidisciplinary research plan and translational approach. Likelihood that the research will lead to extramural research funding. Training Plan: Quality, appropriateness, and multidisciplinary complementarity of the proposed mentor, mentor experience and plan for additional didactic and other training at MUSC or elsewhere. Resources: Tangible commitment and resources provided by the home department/division, and suitability of the available clinical and laboratory infrastructure and multidisciplinary team. Career Potential: Global assessment of the likelihood that the candidate will develop a career as an outstanding independent clinical investigator who will lead multidisciplinary teams and have an important impact on health. * A SCTR Biostatistics Consultation is required for all applicants. Schedule your consultation as soon as possible. This will provide you valuable statistical & study design information that you will likely want to incorporate in to your research plan. Requests must be submitted via SPARC Request by Friday, March 14, but it is advised to begin this process even earlier. See FAQ s for consultation request procedure. http://sctr.musc.edu/index.php/education/k12 SCTR has resources and consultation services (in biostatistics, recruitment, regulatory, Nexus clinical / lab services, innovation, ethics, community engagement, comparative effectiveness, novel methods, & biomedical informatics) that can help investigators during the application process to insure your ability to develop a complete proposal. 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. PROGRAM REQUIREMENTS 1. Duration of the Award Starting July 1, 2014, K12 Clinician Scientists who enter the program will receive two years of salary support at 40% effort subject to NIH salary cap and an annual research supply budget of $20,000 ($5,000 from the K12 program, and $15,000 in department/division match). Each year of funding is contingent on satisfactory participation in K12 activities and progress toward the scholar's individual career goals, and continued support from the Scholar's mentor and department. We strongly encourage that a minimum of $1,000 is budgeted to fund the SCTR K12 CLINICIAN SCIENTIST PROGRAM 3

awardees attendance at the annual Translational Science Conference. A third year of funding will only be considered if circumstances are justified, all program requirements had been met in previous years and there is high probability of extramural funding in the near future. 2. Training in Clinical Research Formal training in comprehensive clinical research is important for establishing independence as a clinical investigator and we believe that a secondary degree in a clinical research-related field may be an important representation of this training. In general: Scholars will be required to obtain training in clinical and translational research as a K12 Clinician Scientist, whether a MSCR is pursued or personally developed training is sought. Scholars holding an MSCR or other formalized clinical and/or translational degree must include an outline for additional training in their Training Plan in the application. Scholars will participate in a Program Orientation held in collaboration with MUSC s additional mentored training programs. Scholars will participate in a didactic grantsmanship program in the Fall in which sessions will meet weekly for a 6-8 week duration. We strongly recommend that all Scholars enroll in other courses and workshops in disciplines relevant to their career development plans; these should be planned in discussions with your mentor. 3. Mentor Developing a successful clinical research career requires strong relationships with mentors and research team members. Each Scholar is required to have a primary mentor. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of the Clinician Scientist Award. 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 mentor must be familiar with faculty, resources and databases at MUSC, and have resources and research staff that can support the Scholars' research. The mentor 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 40% of the Scholar's total work week is protected from clinical and administrative duties, and fully available for training and research. Scholars will meet at least monthly with their mentor, both individually and in conjunction with other members of the research team, as appropriate. The mentor is required to work with the Scholar on a Career Development Plan and outline of Annual Research Goals. This plan should be provided to the program leadership and updated at quarterly progress meetings. Each scholar & mentor is also expected to meet periodically with her/his division head/department chair, as they will oversee the scholar's departmental interactions and academic advancement. SCTR K12 CLINICIAN SCIENTIST PROGRAM 4

As part of this Mentoring relationship & partnership with the Clinician Scientist Program mentors will be expected to play a fully involved role in the Clinician Scientist Program by: Attending the Scholar s Program Orientation & quarterly progress meetings Participation in SCTR s Annual Mentor Training Retreat Regularly attending K to R Club meetings, especially during scholar presentations and; Participation as a reviewer in SCTR s Collaborative K Program Mock Study Sections 4. 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 K12 award period (or earlier), we set out these general guidelines for scholars to consider: 1st year: Complete approved plan of research and timeline Have obtained IRB approval Complete Fall Grantsmanship Course and present twice at the K to R Club If applicable, completion of the Core Clinical Research Training Course One or more high quality publications that may form the basis of a grant application. 2nd year: One or more high quality publications that may form the basis of a grant application. Submit proposal for review to a K Scholar Mock Study Section Submit an extramural grant (typically R01, K23, or other federal, state, foundation or industry grant) Present twice to the K to R Club Optional 3rd Year: A third year of funding will only be considered if circumstances are justified, all program requirements had been met in previous years and there is high probability of extramural funding in the near future. Example: A grant submission was reviewed and scored, but not funded and development of a resubmission would be benefitted by the additional support. Scholars are required to meet with program leadership quarterly to discuss the research project, training advancements and provide feedback to aid in the progress and success of this award. SCTR K12 CLINICIAN SCIENTIST PROGRAM 5

APPLICATION Candidates must complete the application following the instructions included in the application packet. Applications are due by NOON April 2, 2014. The application instructions and format can be located on the SCTR website (http://sctr.musc.edu/index.php/education/k12). Please contact Rebecca Barry, SCTR Project Coordinator (barryr@musc.edu or 843-792-1497) with any questions. INSTRUCTIONS (The application must be typed using Arial 11 font with 1 margins all around and adherence to the page limitations specified) I. Basic Data 1. Online Application Form. Follow the K12 Application link on the SCTR website at http://sctr.musc.edu/index.php/education/k12 and complete the online application. 2. Required Uploads on the Application Form include: a. Applicant Biosketch new NIH 4-page format (see PHS 398 instructions) b. Mentor Biosketch - new NIH 4-page format (see PHS 398 instructions) c. Mentor s Statement (see instructions below, template available online) d. Mentor s Training Table (see instructions below, template available online) e. Department/Division Chair Statement (see instructions below, template available online) f. Candidate s Statement (see instructions below) g. Project Summary and Relevance (see instructions below) h. Research Plan (see instructions below) II. Mentor s and Department Chair s Statements The candidate s mentor must complete a Mentor s/consultant s Statement following the format provided and not exceeding the 1 page limit, PDF format, separate upload on the K12 application site http://sctr.musc.edu/index.php/education/k12 The candidate s Department Chair/Division must complete a Statement following the format provided and not exceeding the 1 page limit, PDF format, separate upload on the K12 application site http://sctr.musc.edu/index.php/education/k12 SCTR K12 CLINICIAN SCIENTIST PROGRAM 6

MENTOR STATEMENT Limit response to what fits on this page, blank template provided at http://sctr.musc.edu/index.php/education/k12 (Arial 11 Font, 1 Margins all around) Candidate Name: Mentor Name: Title: Email address: 1. Current and Former Trainees. (Provide Training Table, template available online add additional lines if needed) 2. Please briefly describe the nature and extent of the supervision that you will provide. Briefly comment on the quality of the proposed scholar, their ability to successfully dedicate 40% effort towards a research focused initiative and on the nature of the multidisciplinary collaboration in the research environment that you will help provide. 3. Please indicate all that you will provide to support the candidate s research. Be specific as to amount of space, staff, clinical and lab resources, and dollars you will make available to the scholar (this has an important impact on our funding decision). I have read and understand the expectations of mentors/consultants in the RFA, and agree to be the Mentor/Consultant for the candidate named above in the event he or she is selected. Signature: Date: SCTR K12 CLINICIAN SCIENTIST PROGRAM 7

Candidate s Name: Chair s Name: Department: Email: DEPARTMENT CHAIR OR DIVISION HEAD STATEMENT Limit response to what fits on this page, blank template provided at http://sctr.musc.edu/index.php/education/k12 (Arial 11 Font, 1 Margins all around) 1. Please specifically describe the role that the candidate will have in your department as a leading force in multidisciplinary clinical and translational research after completing the career development award. 2. Please indicate all that you will provide to support the candidate s research. Be specific as to amount of space, number and kind of staff, clinical and lab resources, and dollars you will make available to the scholar (this has an important impact on our funding decision). I support this proposal for a career development award in multidisciplinary clinical & translational research and certify that if he/she is selected as a K12 Scholar he/she will be able to devote at least % effort to the SCTR K12 program, including clinical and translational research carried out in my division/department. (This should be based on the entire amount of time worked in a typical week; fill in 40% unless you ve negotiated something different.) I will also support this proposal by providing tuition, fees and books for the K12 Clinician Scientist for the duration of his/her participation in the SCTR K12 whether he/she participates the MSCR program part time or creates his/her own training component. Signature: Date: SCTR K12 CLINICIAN SCIENTIST PROGRAM 8

III. The Candidate s Statement (Not to exceed 3 pages, PDF format, separate upload on the K12 application site http://sctr.musc.edu/index.php/education/k12 ) On 3 pages, and with the five scholar selection criteria as subheadings, please address the following considerations. 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; written product attached to the application Describe any previous training in clinical and translational research (e.g., MSCR degree, MSTP program, previous mentored program, etc.). Give examples of opportunities you ve had to engage in research (basic or clinical); describe your role in these projects. Highlight examples of your productivity (e.g., pursuing an original research question, analyzing data, pursuing extramural funding, and presenting or publishing your findings). Research plan overview: Scientific value, potential clinical importance, and feasibility of the written multidisciplinary research plan State your long-term clinical and translational research career goal(s), including the type of research you plan to conduct, the clinical problem(s) your research will address, and the potential impact your research will have on human health. Explain how conducting the research project proposed in this application will prepare you to compete successfully for an NIH grant, such as an R03, R21, or R01 and provide some scenarios for what that project would be. Training plan: Quality, appropriateness, and multidisciplinary complementarity of the proposed mentors, and plan for additional didactic and other training at MUSC or elsewhere Explain what additional training you need to achieve your research career development goals. Identify specific areas where you have deficiencies and describe how you will obtain additional training in each area. Describe the roles each of your mentors will play. Be specific; cite examples from your proposed training or research plan whenever possible. Resources: Tangible commitment and resources provided by the home department/division, and suitability of the available clinical and laboratory infrastructure and multidisciplinary team Comment on the resources (space, staff, clinical materials, funds, etc.) provided by your department and mentors, and their adequacy to your career development. Be specific as to amounts that will be available to you for doing research. 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 Explain how you will benefit from the K12 program and how it will contribute to your career in multidisciplinary clinical and translational research. Comment on the leadership role you expect to play in your department in 5-10 years. SCTR K12 CLINICIAN SCIENTIST PROGRAM 9

IV. Project Summary and Relevance This is included in the online application as a separate upload in the Abstract Upload field, 250- word limit. It is meant to serve as a succinct and accurate description of the proposed work when separated from the application. State the broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving the stated goals. This section should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate reader. Avoid describing past accomplishments and the use of first person. The Relevance component should describe the significance of this research to public health using no more than two or three sentences. In this section, be succinct and use plain language that can be understood by a general, lay audience. V. Research Plan You should work closely with your mentors on writing the research plan. Follow instructions in PHS 398 and provide a research plan that does not exceed 8 pages. PDF format, separate upload on the application site http://sctr.musc.edu/index.php/education/k12 Format (Arial 11 font, 1 margins all around, 8 page limit) The research plan should be described along the lines of section instructions contained in PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html). No introduction or cumulative inclusion enrollment report is needed. Design the research to be completed in less than two years, to allow for time for grant submissions & review processes. Research Plan (8-page limit, combine in one PDF document) A. Specific Aims B. Research Strategy (Significance, Innovation, Approach) C. Bibliography and References Cited (not included in page limit) D. Protection of Human Subjects, Inclusion of Women & Minorities, Planned Enrollment Report and Inclusion of Children, if applicable (not included in page limit) E. Vertebrate Animals, if applicable (not included in page limit) SCTR K12 CLINICIAN SCIENTIST PROGRAM 10