South Carolina Clinical & Translational Research Institute (SCTR) KL2 Multidisciplinary Scholars Program in Clinical & Translational Science

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1 South Carolina Clinical & Translational Research Institute (SCTR) KL2 Multidisciplinary Scholars Program in Clinical & Translational Science SCTR Principal Investigator: Kathleen T. Brady, MD, PhD SCTR Co-PI: Perry Halushka, PhD, MD KL2 Program Director: Marc Chimowitz, MB ChB SCTR Project Director: Randal Davis For information Rebecca Barry: KEY DATES Call for Applications October 4 th, 2012 Letter of Intent November 15 th, 2012 KL2 Applications Due January 4 th, 2013 Appointment Start Date April 1 st, 2013 KEY INFORMATION Number of Slots: 1 Term: Effort Requirement: 75% Apply via the SCTR website: 2 years plus option for an additional 3 rd year OVERVIEW The Medical University of South Carolina announces funding for the KL2 Mentored Career Development Program for Multidisciplinary Scholars as an essential component of our NIH/NCATS-funded CTSA award (Clinical and Translational Science Award). The KL2 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 & translational research and increase research capacity through the training of junior faculty, and bridging clinical & translational research with research independence. This year, one Scholar will be selected for a career development award to begin April 1 st, The Scholar will receive salary support at 75% effort (subject to NIH salary caps - see Salary & Time Commitment under Eligibility) per year through March 31, 2016 (contingent on evidence of scholar progress and grant funding) to pursue multidisciplinary clinical & translational research with training and mentoring. The Scholar will also receive an annual supply budget of $25,000 to purchase research supplies and small equipment.

2 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, startup 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 or select to pursue a Masters of Science in Clinical Research (MSCR) degree in combination with other training opportunities. ELIGIBILITY Junior faculty and senior fellows pending faculty appointment with a doctorate who are committed to a career in clinical or translational 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 and translational 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. Generally, a minimum of 75% of a Scholar's full-time professional effort must be devoted to the KL2 program for the training and clinical research activities, subject to NIH salary caps. The 75% effort is based on the entire amount of time worked in a typical week, and should be proportionate. 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. With justification, candidates from clinical specialties that require more direct patient care (e.g. surgical specialties) may be funded at less than 75% effort to the KL2 program, but no less than 50%. Special permission must be obtained for eligible faculty with Veterans Affairs (VA) appointments. Contact Rebecca Barry (barryr@musc.edu) to discuss prior to applying. 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. Applicants cannot be appointed as a Scholar if they have pending K-series grant applications under review at the time of appointment. KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 2

3 SCHOLAR SELECTION CRITERIA The campus-wide Multidisciplinary KL2 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. Recruitment plans must demonstrate feasibility within the time frame of this award due to the need to begin external funding applications by the end of the projects second year. Training Plan: Quality, appropriateness, experience and availability of the proposed mentor(s), 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 assessments of the likelihood that the candidate will develop a career as an outstanding independent clinical or translational investigator who will lead multidisciplinary teams and have an important impact on health. SCTR has resources and consultation services (such as biostatistics, budget, recruitment, regulatory, coordinator core, intellectual property, and CTRC consultations) that can help investigators during the application process to insure your ability to meet the requirements of the program and that they are fully explained. We strongly encourage the use of needed resources. Please submit your request for a consultation using the online service request system at 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. KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 3

4 PROGRAM REQUIREMENTS 1. Duration of the Award Starting April 1 st, 2013, the KL2 Scholar will receive (through March 31, 2016) salary support at 75% effort subject to NIH salary caps and an annual research supply budget of $25,000. Each year of funding is contingent on satisfactory participation in KL2 activities and progress toward the scholar's individual career goals, and continued support from the Scholar's mentor and department. An additional $1,000 is awarded to fund the scholar s attendance at the annual Translational Science Conference in Washington DC each April 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 KL2 Scholar, whether through obtaining a Master of Science in Clinical Research or a personally developed training / career development plan. Scholars holding an MSCR or other formalized clinical and/or translational degree must include an outline for additional training in their application s Training Plan. Scholars are encouraged to complete a Clinical & Translational Research Center (CTRC) rotation by the end of their second program year. CTRC Rotations are month long programs offered each fall and spring term. Scholars are required to attend the SCTR K to R Club meetings, in which scholars present their research plans to an audience of their peers and mentors twice a year in order to gain feedback to strengthen grant application submissions. These meetings occur monthly. Scholars are required to participate in SOCRATES / B&BS meetings, which provides a forum for junior faculty to present research projects and receive constructive feedback for improving and enhancing studies & proposals, networking opportunities & development of mentoring skills. These meeting occur twice a month. We strongly recommend that all Scholars enroll in other courses and workshops in disciplines relevant to their career development plans at MUSC and at other institutions; these should be planned in discussions with your mentor and MUSC KL2 consultants. Individuals who are selected as Scholars and who chose to obtain a Master's Degree as part of their training plan must complete a separate application for a Master's of Science in Clinical Research. For application and additional information on the MSCR program, please contact Dr. Thomas C. Hulsey, MSCR Program Director ( hulseytc@musc.edu) or Maritza Dawkins-Holnes, MSCR Program Coordinator ( dawkin@musc.edu). KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 4

5 3. Mentor Developing a successful clinical & translational research career requires strong relationships with mentors and a research team. Each Scholar will have a mentor (with an MUSC faculty appointment) and may have an additional consultant. 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 KL2. A consultant, if identified, should have specific expertise in the area of proposed research necessary to furthering the Scholar s research plan. Mentors will have overall responsibility for helping Scholars develop creative and independent careers in translational 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 75% of the Scholar's total work week is protected from clinical and administrative duties, and fully available for training and research. We strongly encourage mentors to participate in SCTR s annual mentor training retreat, as mentoring K s is an area of focus at this training event. 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. This plan should be provided to the steering committee before the end of the first year of the scholar s tenure and may be reviewed and revised at the end of the second year. The Scholar and Mentor Team is also required to meet quarterly with the SCTR Institute KL2 Director or his designee and provide progress reports and discuss the current status of the research project and determine that metrics towards successful career development progress is being met. In addition, a one page Training Individual Progress Report from the mentor is required as part of the CTSA Annual Progress Report due to NIH at the end of January every year. Each scholar 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. 4. Scholar career development plans, progress reports, and performance feedback Scholar Milestones Since our shared goal is for Scholars to become independently funded before the end of their KL2 award period, we set out these general guidelines for scholars to consider: Upon notification of award: A required KL2 Orientation must be attended by the Scholar and Mentor. Appropriate approvals such as CITI training completion reports, IRB numbers, IACUC numbers, Certificates of Confidentiality, IND s, etc. must be submitted for our regulatory records. Budget modifications must be submitted for approval. Scholars will be required to use SCTR resources to ensure they are compliant with University regulations and the guidelines of Good Clinical Practice. KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 5

6 By the end of the 1st year: Scholars are required to attend and submit an abstract for poster presentation to the annual Translational Science Conference in Washington, D.C. each April. Submission of a Career Development Plan created in conjunction with the Mentor. By the end of the 2nd year: One or more high quality publications that may form the basis of a grant application. 1 extramural grant of any size submitted (typically R21, R03, or other federal, state, foundations or industry grant) Successful completion of the CTRC Rotation By the middle of the 3rd Year: One multidisciplinary, extramural competitive grant submitted if not achieved in the second year or resubmission of a previously unfunded submission. Scholar Performance Reviews Scholars along with their mentors will meet with the KL2 Director every 3 months to provide a progress report on the status of their approved project. Reports are to be submitted online 2 weeks prior to each meeting for review. Often, assignments will be made to the scholar of tasks to complete with in a time line or issues to fully consider prior to the next progress meeting. Successful completions of these progress meetings are required to continue funding from year to year. KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 6

7 LETTER OF INTENT Interested applicants need to submit a letter of intent via by November 15 th to Rebecca Barry, barryr@musc.edu. Please indicate your interest and the following details: Your name, position, department, college, proposed project title, proposed mentor & any additional consultants. Letters of intent are not a requirement; they will only be used to help identify appropriate reviewers in an ample amount of time. APPLICATION Candidates must complete the application following the instructions below by NOON January 4 th, 2013 The online application and blank templates can be located on the SCTR website ( Click the Apply Now link to log into the online application system. Please contact Rebecca Barry, SCTR Project Coordinator (barryr@musc.edu or ) with any questions. I. Basic Data APPLICATION INSTRUCTIONS (The application must be typed using Arial 11 font with 1 margins all around and adherence to the page limitations specified) 1. KL2 Online Application. Follow the Apply Now link on the SCTR website at 2. NIH Biosketches must be in the new NIH 4-page format. II. Mentor s, Consultant s and Department Chair s Statements The candidate s mentor, consultant (if applicable) and Department/Division Chair must submit a statement of support following the format provided and not exceeding the 1 page limit, PDF format, separate upload in the KL2 online application. KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 7

8 Candidate Name: Mentor Name: Title: address: MENTOR STATEMENT & CONSULTANT STATEMENT FORM Limit response to what fits on this page, blank template provided at (Arial 11 Font, 1 Margins all around) 1. Current and Former Trainees. (Fill in the attached table on the following page 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 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, 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). In addition include the planned frequency of mentor/mentee meetings and metrics by which satisfactory progress will be measured. 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: KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 8

9 Candidate s Name: Chair s Name: Department: DEPARTMENT CHAIR OR DIVISION HEAD STATEMENT Limit response to what fits on this page, blank template provided at (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 KL2 Scholar he/she will be able to devote at least % effort to the SCTR KL2 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 75% unless you ve negotiated something different.) I will also support this proposal by providing tuition, fees and books for the KL2 Scholar for the duration of his/her participation in the SCTR KL2 whether he/she participates the MSCR program part time or creates his/her own training component and is considered a full time student. I also acknowledge that the tuition will be based on the NIH NRSA tuition calculation used for T32s. Signature: Date: KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 9

10 III. The Candidate s Statement (Not to exceed 3 pages, PDF format, separate upload on the online KL2 application) CANDIDATE S STATEMENT Format (Arial 11 font, 1 margins all around, 3 page limit) Using the five subheadings, 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 mentor 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 (this is as important as your research 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. Provide measurable milestones towards achieving an independent research career. Describe the roles each of your mentors will play and frequency of your proposed mentee/mentor meetings. 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 KL2 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 KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 10

11 IV. Research Plan You should work closely with your mentor(s) on writing the research plan. Provide a plan that does not exceed 6 pages (not including human subjects, lit cited, and budget). PDF format, separate upload in the KL2 online application. RESEARCH PLAN Format (Arial 11 font, 1 margins all around, 6 page limit for Sections A & B) The research plan & budget should be prepared using PHS398 instructions for Items A-E below. Design the Research Plan to be completed within the time frame of the award, which requires external grant submission(s) by the end of year 2. A. Project Description (including Summary & Relevance) 1 page B. Research Strategy (5 pages)** Significance Innovation Approach C. Human Subjects (not included in 6-page limit) D. Literature Cited (not included in 6-page limit) E. Budget & Justification (Not included in 6-page limit. Provide your initial budget plans for year 1 for the $25,000 project budget. Fill in the blank form found here: **NOTE: Prior to submitting a KL2 application, candidates are REQUIRED to receive a SCTR Biostatistical Consultation. Submit this request through SPARC ( Further, Research Plans must clearly demonstrate that a recruitment feasibility study has been conducted to successfully complete the project within the initial 2-year project (essentially, indicate that a sufficient population exists to complete the proposed work). KL2 MULTIDISCIPLINARY SCHOLARS PROGRAM 11