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Career Advancement Program for Clinical Research Scholars (CAPS) ORIENTATION TBS

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  • 1.Career Advancement Program for Clinical Research Scholars (CAPS) ORIENTATION TBS

2. Opening Remarks Russell V. Luepker, MD, MS Mayo ProfessorDivision of Epidemiology & Community Health School of Public Health CAPS Program Director 3. NIH Roadmap andCAPS Program Overview Russell V. Luepker, MD, MS Mayo ProfessorDivision of Epidemiology & Community Health School of Public Health CAPS Program Director 4. NIH Roadmap Goal Goal of K12 NIH Roadmap: ...to educate future leaders of multidisciplinary clinical research and speed the translation of research discoveries into improved patient care. 5. NIH Roadmap Re-engineering the Clinical ResearchEnterprise Research Teams of the Future New Pathways to Discovery 6.

  • Difficulty recruiting and retaining clinical researchers
  • Rising overhead costs and regulatory demands
  • Limitations due to NIH funding mechanisms, review, and program structure
  • Lack of a viable career pathway deters investigators from conducting clinical and translational research impedes basic research results from entering into clinical practice

How Did We Get Here? 7. Challenges of Interdisciplinary Research

  • The current system of academic advancement favors the independent investigator
  • Most institutions house scientists in discrete departments
  • Interdisciplinary science requires interdisciplinary peer-review
  • Project management and oversight is currently performed by discrete ICs
  • Interdisciplinary research teams take time to assemble and require unique resources

8. Multidisciplinary Clinical Research Career Development Program

  • Roadmap K12 Program is designed to increase the national pool of clinician-scientists from many disciplines
  • The program differs in its goal by supporting career development of the clinical research team
  • The clinical research team includes:nurses, sociologists, pharmacologists, biostatisticians, and epidemiologists, in addition to physicians, dentists, and other scientists.
  • Funding for up to 5 years includes didactic and practical training in design, conduct, and analysis of clinical research
  • Each clinical research scholar may be recruited from within a grantee institution or externally and has two mentors

9. CAPS Program Goals

  • CAPS is more than a training program.
  • Goals:
  • to train clinical researchers
  • to launch Scholars careers
  • to increase the number of interdisciplinary researchers who are working together

10. CAPS Overview

  • Minnesotas Approach
  • Core Competencies
  • Training Program
  • Expectations
  • Scholars & Mentoring Teams
  • MAC
  • Shared Resources
  • Ombudsman

11. Minnesotas Approach

  • Faculty Career DevelopmentProgram
  • Executive Committee
  • Multidisciplinary Scholars
  • Mentoring Teams
  • Infrastructure Support
  • Research Support
  • Evaluation
  • Upper Midwest Consortium

12. CAPS Core Competencies

  • Study concepts
  • Study designs
  • Multidisciplinary collaboration
  • Research funding
  • Planning and managing research studies
  • Human Subjects Protection and Responsible Conduct of Research
  • Data collection, management, & analysis
  • Data interpretation
  • Reporting study findings (publications)
  • Professional presentation of study results

13. Training Program

  • MS in Clinical Research or related field
  • Additional CAPS courses and seminars
    • Career Development seminar (PubH 6309)
    • AHC Clinical Research Conference
    • Management for Clinical Research (PubH 6572)
  • NIH CTSA KL2/K12 Annual Meeting
  • Midwest Consortium

14. Training Program (contd) MS Clinical Research (38 cr)

  • Fundamentals of Clinical Research (3 cr)
  • Epidemiologic Methods I & II (3 cr each)
  • Biostatistics I & II (4 cr each)
  • Clinical Trials (3 cr)
  • Clinical Research Project Seminar (2 cr)
  • Writing Research Grants (2 cr)
  • Ethics in Public Health: Res & Policy (1 cr)
  • Thesis Credits: Masters (10 cr)
  • Electives (3 cr)

15. Training Program (contd) Other Masters Level Degrees

  • MS in Health Services Research and Policy
  • MS in Clinical Investigation
  • MS in Social, Administrative, and Clinical Pharmacy - Experimental and Clinical Pharmacology Track
  • MPH in Epidemiology

16. CAPS Expectations

    • Commit 75% effort to CAPS-related training, research, and career development activities (50% effort for surgical scholars).
    • Commit no more than 25% total effort to clinical duties, teaching, and departmental administrative duties.
    • Post and update Career Development Plan, Ground rules, Confidentiality Agreement, and Mentoring Team interactions on mentor team website.
    • Meet regularly with mentoring team.
    • Participate in all CAPS-specific activities (seminar, conferences, workshops, etc).
    • Complete MS degree program (if not completed prior to CAPS).
    • Register for additional CAPS-specific courses.
    • Submit one peer-review article for publication per year (exceptions granted for full-time MS program students in first K12 year)
    • Presentations
    • Grant proposal (by end of CAPS period)

17. Career Advancement Program for Clinical Research Scholars (CAPS) Introductions 18. CAPS 2008 Scholars

  • Scholar: Aviva Abosch, MD, PhD, Assistant Professor, Neurosurgery
  • Mentors: Apostolos P. Georgopoulos, MD, PhD, Professor, Neuroscience; Jon E. Grant, MD, MPH, Associate Professor, Psychiatry; Kamil Ugurbil, PhD, Professor, Center for Magnetic Resonance Research; Lynn E. Eberly, PhD, Associate Professor, Biostatistics
  • Project Title: Compulsive Behavior in Patients with Parkinsons Disease before and after Deep Brain Stimulation

19. CAPS 2008 Scholars

  • Scholar: Jason Baker, MD, MS, Assistant Professor, Infectious Diseases & International Medicine, HCMC
  • Mentors: James D. Neaton, PhD, Professor, Biostatistics; W. Keith Henry, MD, Professor, UMN AIDS Clinical Trials Unit, HCMC; Richard Grimm, MD, PhD, MPH, Professor, Cardiology/ Epidemiology; Daniel A. Duprez, MD, PhD, Professor, Cardiology
  • Project Title: Small and Large Arterial Elasticity and HIV Infection:a pilot study

20. CAPS 2008 Scholars

  • Scholar: Monica Colvin-Adams, MD, Assistant Professor, Cardiology
  • Mentors: Daniel J. Garry, MD, PhD, Professor, Cardiology;
  • Daniel A. Duprez, MD, PhD, Professor, Cardiology; Robert F. Wilson, MD, Professor, Cardiology; John E. Connett, PhD, Professor and Head, Biostatistics; Robert Bache, MD, Professor, Cardiology
  • Project Title: Phosphodiesterase-5 Inhibition and Cardiac Allograft Vasculopathy

21. CAPS 2008 Scholars

  • Scholar: Sean Elliott, MD, Assistant Professor, Urologic Surgery
  • Mentors: Timothy J. Wilt, MD, MPH, Professor, Internal Medicine; Beth A. Virnig, PhD, MPH, Associate Professor, Health Services Research, Policy, and Administration; Robert L. Kane, MD, Professor, Health Policy and Management; Roger Feldman, PhD, Professor, Health Policy and Management; Bradley P. Carlin, PhD, MS, Mayo Professor, Biostatistics
  • Project Title: The influence of financial incentives on practice patterns and outcomes in prostate cancer therapy

22. CAPS 2008 Scholars

  • Scholar: Lynda Polgreen, MD, MS, Fellow, Pediatric Endocrinology
  • Mentors: Anna Petryk, MD, Assistant Professor, Pediatric Endocrinology; Antoinette M. Moran, MD, Professor, Pediatrics; Chester B. Whitley, MD, PhD, Professor, Pediatrics; William Thomas, PhD, MS, Associate Professor, Biostatistics
  • Research Project :To study bone health in two related populations: children after hematopoietic cell transplantation (HCT) and children with Mucopolysac-charidosis (MPS) diseases with and without HCT and/or enzyme replacement therapy (ERT)

23. CAPS 2008 Scholars

  • Scholar: Steven Stovitz, MD, Assistant Professor, Family Medicine and Community Health; Adjunct Faculty, Kinesiology
  • Mentors: Robert W. Jeffrey, PhD, Professor, Epidemiology and Community Health; John H. Himes, PhD, Professor, Epidemiology and Community Health; Mark A. Pereira, PhD, Associate Professor, Epidemiology and Community Health; Peter J. Hannan, MStat, Senior Research Fellow, Epidemiology and Community Health
  • Research Project: To study childhood growth features which predict adult obesity utilizing the CATCH and SOLAR databases

24. CAPS 2008 Scholars

  • Scholar: Fareed Suri, MD, Fellow, Neurology
  • Mentors: Aaron R. Folsom, MD, MPH, Professor, Epidemiology and Community Health; Adnan I. Qureshi, MD, Professor, Neurology; Cavan S. Reilly, PhD, MS, Associate Professor, Biostatistics
  • Project Title: Renin-Angiotensin System Polymorphisms and Risk of Small Vessel Ischemic Stroke Analysis from a Cardiovascular Cohort

25. CAPS 2006 Scholars

  • Scholar: Lisa Chow, MD, Assistant Professor, Endocrinology
  • Mentors:Elizabeth R. Seaquist, MD, Professor, Medicine;
  • Michael Garwood, PhD, Professor, Radiology;
  • Lynn E. Eberly, PhD, Associate Professor, Biostatistics
  • Project Title: Evaluation of Intramyocellular Lipid Content (IMCL) in Skeletal Muscle by Magnetic Resonance Spectroscopy
  • Scholar: Sarah A. Cooley, MD, Assistant Professor, Adult Hematology, Oncology and Transplantation
  • Mentors: Jeffrey S. Miller, MD, Professor, Medicine;
  • Daniel J. Weisdorf, MD, Professor, Hematology, Oncology and Transplantation; Chap T. Le, PhD ,Distinguished Professor, Biostatistics
  • Project Title: Natural Killer Cell Receptors

26. CAPS 2006 Scholars

  • Scholar:Kamakshi Lakshminarayan, MD, Assistant Professor, Neurology
  • Mentors: David C. Anderson, MD, Professor, Neurology;
  • Russell V. Luepker, MD, MS, Mayo Professor, Epidemiology & Community Health; Beth A. Virnig, PhD, MPH, Associate Professor, Health Services Research, Policy, and Administration;
  • David R. Jacobs, Jr., PhD, Professor, Epidemiology & Community Health
  • Project Title:Improving Evidence-Based Quality of Care in Acute Stroke
  • Scholar: Peter Milev, MD, PhD, Assistant Professor, Psychiatry
  • Mentors: Kelvin O. Lim, MD, Professor, Psychiatry;
  • Angus W. MacDonald III, PhD, Assistant Professor, Psychology; Susanne S. Lee, PhD, Assistant Professor and Statistician, Psychiatry
  • Project Title:Deficits in perceptual organization and thought disorder in schizophrenia: relationships with fMRI functional anatomy

27. CAPS 2006 Scholars Scholar: Daniel A Mulrooney, MD, MS, Assistant Professor, Pediatrics; Pediatric Hematology, Oncology, Blood and Marrow Transplantation Mentors:Joseph P. Neglia, MD, MPH, Professor, Pediatrics;Robert P. Hebbel, MD, Professor, Hematology, Oncology and Transplantation; James D. Neaton, PhD, Professor, BiostatisticsProject Title:Atherosclerosis in Survivors of Childhood and Young Adult Hodgkins Disease Scholar: Marcie R. Tomblyn, MD, MS, Assistant Professor, Hematology, Oncology and Transplantation Mentors: Daniel J. Weisdorf, MD, Professor, Hematology, Oncology and Transplantation; Mary M.Horowitz, MD, Professor, Medicine, Medical College of WI; John P. Klein, PhD, Professor, Biostatistics, Medical College of WI; Brent R. Logan, PhD, Assistant Professor, Biostatistics, Medical College of WI Research Project:To design and execute local and multi-center trials to advance hematopoietic stem cell transplant (HSCT) for management of lymphoma 28. CAPS 2006 Scholars Scholar: Heather E. Vezina, PharmD, Assistant Professor, Laboratory Medicine and Pathology/Experimental and Clinical Pharmacology Mentors: Henry H. Balfour, Jr., MD, Professor, Lab Medicine and Pathology/Pediatrics; Richard Brundage, PharmD, PhD, Associate Professor, Pharmacy; William Thomas, PhD, Associate Professor, Biostatistics Project Title : Pharmacokinetic and pharmacodynamic characteristics of valacyclovir (V-ACV) in adults with primary Epstein-Barr virus (EBV) infectious mononucleosis (IM) 29. CAPS 2007 Scholars Scholar: David R. Boulware, MD, Assistant Professor, Infectious Diseases & International Medicine Mentors:Paul R. Bohjanen, MD, PhD, Associate Professor, Microbiology and Medicine; Edward N. Janoff, MD, Professor, Infectious Diseases, University ofColorado at Denver; James D. Neaton, PhD, MS, Professor, Biostatistics; Tracy L. Bergemann, PhD, Assistant Professor, Biostatistics Project Title:Immune Reconstruction Syndrome in HIV-infected Persons in Resource-Limited Areas Scholar: Adam F. Carpenter, MD, Assistant Professor, Neurology Mentors:Apostolos P. Georgopoulos, MD, PhD, Professor, Neuroscience;Gareth J. Parry, MD, Professor, Neurology; Kelvin O. Lim, MD, Professor, Psychiatry; Lynn E. Eberly, PhD, Associate Professor, Biostatistics Project Title:Protein markers of disease in Multiple Sclerosis (MS) 30. CAPS 2007 Scholars

  • Scholar: Melissa A. Geller, MD, Assistant Professor, Obstetrics, Gynecology and Women's Health
  • Mentors: Amy P. N. Skubitz, PhD, Associate Professor, Laboratory Medicine and Pathology; Sundaram Ramakrishnan, PhD, Professor, Pharmacology; Douglas Yee, MD, Professor, Hematology, Oncology and Transplantation;Chap T. Le, PhD, Professor, Biostatistics
  • Project Title:Neoadjuvant Chemotherapy in Ovarian Cancer: Predicting Tumor Response
  • Scholar: LAurelle A. Johnson, PhD, Assistant Professor, Experimental & Clinical Pharmacology
  • Mentors: Timothy S. Tracy, PhD, Professor, Pharmacy;
  • Pamala A. Jacobson, PharmD, Associate Professor, Pharmacy;
  • Julie A. Ross, PhD, Professor, Pediatrics; Antoinette M. Moran, MD, Professor, Pediatrics; Melanie M. Wall, PhD, MS, Associate Professor, Biostatistics
  • Project Title:The effect of childhood obesity on phase 1 and phase 2 drug metabolism enzymes

31. CAPS 2007 Scholars

  • Scholar: Ken M. Kunisaki, MD, MS, Assistant Professor, Pulmonary, Allergy, Critical Care, and Sleep Medicine
  • Mentors: Dennis E. Niewoehner, MD, Professor, Pulmonary Section, VAMC; Allen S. Levine, PhD, Professor and Dean, College of Food, Agricultural and Natural Resources Sciences; John E. Connett, PhD, Professor and Head, Biostatistics
  • Project Title:Micronutrients and Exacerbations of COPD
  • Scholar: Donald R. Nixdorf, DDS, MS, Assistant Professor, Diagnostic & Biological Sciences, Dentistry
  • Mentors: Eric L. Schiffman, DDS, MS, Associate Professor, Dentistry; David A. Bereiter, PhD, Professor, Dentistry; Kamil Ugurbil, PhD, Professor, Center for Magnetic Resonance Research; Noam Harel, PhD, Assistant Professor, Medicine; James S. Hodges, PhD, MA, Associate Professor, Biostatistics
  • Project Title: Functional Imaging of Trigeminal Neuropathic Pain

32. CAPS 2007 Scholars

  • Scholar: Jeffrey R. Wozniak, PhD, LP, Assistant Professor, Psychiatry
  • Mentors: Kelvin O. Lim, MD, Professor, Psychiatry; Monica A. Luciana, PhD, Associate Professor, Psychology; Pi-Nian Chang, PhD, Associate Professor, Pediatrics/Psychiatry; Paul M. Thuras, PhD, Research Associate, Psychiatry
  • Project Title: Cerebral white matter effects of fetal alcohol exposure: A Diffusion Tensor Imaging (DTI) study of microstructural brain abnormalities and their neurocognitive correlates
  • Scholar: Fang Yu, PhD, RN, Assistant Professor, Adult and Gerontological Health Co-operative Unit, Nursing
  • Mentors: Jean F. Wyman, PhD, RN, FAAN, FGSA, Professor, Nursing Research/Community Health and Family Practice;
  • Maurice W. Dysken, MD, Professor, Psychiatry; Wei Pan, PhD, Associate Professor, Biostatistics
  • Project Title:The FIT-AD Study / Preserving Cognition and Function Through Aerobic Training in Alzheimer's Disease

33. CAPS Executive Committee Russell V. Luepker, MD, MS, Mayo Professor,Epidemiology & Community Health, SPH CAPS Program Director Elizabeth R. Seaquist, MD, Interim Director, OCR; Professor, Medicine; Director, GCRC; CAPS Co-Director James D. Neaton, PhD, Professor, Biostatistics, SPHCAPS Co-Director 34. CAPSMultidisciplinary Advisory Committee

  • Russell V. Luepker, MD, MS (Chair)
  • Linda H. Bearinger, PhD, MS, RN, FAAN
  • David M. Brown, MD, Ombudsman
  • Barbara A. Elliott, PhD
  • Frank A. Lederle, MD
  • Bryan S. Michalowicz, DDS, MS
  • James D. Neaton, PhD
  • Nancy C. Raymond, MD
  • Timothy W. Schacker, MD
  • S. Charles Schulz, MD
  • Elizabeth R. Seaquist, MD
  • William Thomas, PhD, MS
  • Timothy S. Tracy, PhD
  • Todd M. Tuttle, MD, MS
  • Anne Marie Weber-Main, PhD
  • Daniel J. Weisdorf, MD

35. CAPS Ombudsman

  • David M. Brown, MD, Professor Emeritus, Pediatrics/Laboratory Medicine and Pathology
  • Role of Ombudsman
  • to provide scholars with feedback and advice
  • from outside the program
  • to facilitate resolution of program-related difficulties and challenges

36. CAPS & the CTSA ? 37. CAPS Mentoring and Evaluation CAPS Mentoring & Evaluation Director 38. CAPS Mentoring & Evaluation

  • Why the emphasis on mentoring in this program
  • What do we know abouteffectivementoring
  • How the CAPS program facilitates aneffectivementoring approach
  • How the CAPS program evaluated

39. Why Emphasis on Mentoring?

  • Faculty with mentors demonstrate higher levels of success on the following factors:
    • Research productivity (Bland and Schmitz 1986, Byrne and Keefe 2002)
    • Professional socialization and interactions with colleagues (Corcoran and Clark 1984)
    • Salary levels; and satisfaction with salary and promotion (Melicher 2000)
    • Teaching effectiveness, evidenced by declines in teaching anxiety and improved student ratings of teaching effectiveness (Williams 1991).

40. Not all Mentoring is alike

  • Effective faculty mentoring is a result of:
    • Clarity of purpose
    • Systematic tasks and activities that the mentor and mentee do together not personal chemistry
    • Early and enduring mentoring is most beneficial
    • Regular meetings of the mentoring pairs/teams- which may require nudging
    • Using mentors from outside the mentees department is very effective
  • (Boyle and Boice, 1998)

41. CAPS Mentoring Teams

  • Mentoring teams include experienced clinical investigators
  • Teams are multidisciplinary and include a biostatistician
  • Mentors responsibilities are clearly delineated
  • Mentoring process and development of mentees is reviewed regularly
  • Mentors and mentees participate in training workshops
  • Online tracking of mentoring process (meetings and progress) is provided

42. Mentoring Workshops

  • Mentoring Workshop:
  • Scholars attend an initial mentoring workshop with their senior mentors and, preferably, one or more associate mentors.
  • Mentor-to-Mentor Workshop:
  • Senior Mentors attend a mentors-only workshop to provide feedback on the mentoring experience.
  • Dates are posted on the CAPS Website as workshops are scheduled.
  • Next Mentoring Workshop (new Scholars & Mentors):
  • Friday, June 6, 2008 from 1:00-4:00 p.m.
  • at 142 WBOB

43. First Mentoring Workshop forMentors and Mentees

  • Working session to review:
    • Mentees career vision, goals, next years objectives, and activities
    • Mentees incoming strengths and improvement areas
    • Mentoring ground rules and confidentiality agreements
    • Mentoring schedule (team is expected to meet as a group at least quarterly)
    • Role of each mentor on the team

44. Workshop for Mentors Only

  • Working session
    • to review highlights of Scholars progress
    • to review Scholars time distribution
    • to discuss mentoring team roles (individual and group as a whole)
    • to review Scholars satisfaction with mentoring behaviors
    • to review adequacy of mentoring interactions
    • to discuss purpose of multidisciplinary mentoring and how best to achieve it
    • to share strategies for successful mentoring
    • to assess reasonableness of Scholars next years goals and timelines
    • to identify ways CAPS can better support mentoring activities.

45. Online Tracking ofMentoring and Career Development (Optional) Matt Beecher, Informatics Manager,General Clinical Research Center

  • Post career vision, goals, planned strategies, and timeline
  • Post ground rules and confidentiality agreement documents
  • Document mentor team meetings
  • Document use of Shared Clinical Research Support Group (SCRSG)
  • Note decisions from meetings, assignments before next meeting, and goals for next meeting
  • Maintain drafts of projects accessible by whole team
  • Ease mentor tracking burden
  • Aid evaluation without duplication of effort

46. CAPS Scholar Agreement

  • Requirement:
  • 75% effort on CAPS-related training, research, and career development activities (50% surgical scholars)
  • Expectations:
    • Career development plan (post on team website within 2 wks of Mentoring Workshop; update 2 wks prior to scheduled MAC review meetings)
    • Ground rules and confidentiality agreements (post on team website w/in 2 wks of Mentoring Workshop)
    • Regularly scheduled mentoring team meetings (post schedule and interactions on mentor team website - post meetings and action items w/in 2 wks of each interaction)

47. CAPS Scholar Agreement

  • Expectations (continued):
    • Participate in all CAPS-specific activities
    • Complete MS degree program (if notcompleted prior to CAPS) - 9-14 cr in first year; maintain 3.5 GPA
    • Register for additional CAPS-specific courses (all scholars)
    • Peer-review articles (1 per yr - exceptions granted to full-time students in first year)
    • Presentations
    • Grant proposal (by end of CAPS period)

48. CAPS Mentor Agreement

  • Requirement:
  • Assure that scholars spend 75% effort on CAPS-related training, research, and career development activities (50% effort for surgical scholars)
  • Expectations:
  • Attend CAPS Orientation and mentoring workshops
  • Participate in regularly scheduled mentoring teammeetings
  • Senior Mentor provides accountability for scholars work and coordination of team - plans meeting agendas with Scholar to address research and career mentoring topics
  • Complete written mentoring ground rules and confidentiality agreements with scholar
  • Assist scholar with career development plan components including annual goals and objectives with specific strategies and timeline

49. CAPS Mentor Agreement

  • Expectations (continued):
  • Approve career development plan components and subsequent changes (posted on mentor team website)
  • Monitor scholars career development, CAPS activities, and mentoring interactions - review team website entries monthly
  • Assure that scholar is receiving support and resources from home department
  • Provide information for semi-annual program evaluation of mentoring activities
  • Develop plans for grant submission
  • Benefits:
  • Mentor funds for CAPS-related activities including travel, continuing education, CAPS research project support, or salary redistribution

50. CAPS Baseline and Year-End Quantitative Evaluation

  • Evaluation
  • Data collection at the beginning of the program and abbreviated follow-up at the end of each year as well as ongoing mentoring tracking:
    • Scholar Clinical Research Appraisal Inventory
    • Scholar Department/Division Culture
    • Scholar Discipline Identification
    • Mentor Discipline Identification
    • Scholar and Mentor Consent form

51. Baseline Evaluation Forms

  • Evaluation is a CAPS requirement
  • Baseline forms - complete and return to CAPS Administrative Specialist (forms are posted on CAPS website)
  • Consent form - grants permission to use evaluation data for research purposes

52. CAPS ScholarQualitative Evaluation

  • At 6 months, 1 year, and then annually, a MAC Evaluation Subcommittee reviews:
    • Clinical Schedule (protected time)
    • Overall Weekly Schedule (time management)
    • MS Degree Program
    • Current Research
    • Career Development
    • Mentoring Team Interactions
    • Connections in Professional Field
    • Use of Shared Resources
    • Overall CAPS Satisfaction
    • Completion of Evaluation Forms
    • Clinical Research Skills Development

53. Biostatistician Mentors in CAPS James D. Neaton, PhD, MS Professor, Division of Biostatistics, School of Public Health CAPS Co-Director 54. Biostatistician Mentors: General Goals

  • Work with you and the other mentors as part of a multi-disciplinary team
  • Learn about your field and area of research
  • Advise/teach biostatistical topics relevant to your research
  • Convey the value of early biostats mentor involvement re project design, data collection, and problem resolution
  • Discuss potential role of biostatistician mentors on future grants

55. Biostatistician Collaborators Will Work With You To:

  • Formulate study questions
  • Develop study implementation plans
  • Interpret data
  • Determine the next question

56. 57. CAPS Benefits & Administration Russell V. Luepker, MD, MS CAPS Program Director 58. CAPS Benefits

  • Salary and Benefits - commensurate with rank and position (75% effort; 50% for surgical scholars)
  • Tuition and program application fee for up to 14 cr/sem and 6 cr/summer session
  • Travel funds for annual NIH-sponsoredCTSA/K12 Meeting for Scholars , Upper Midwest Consortium meeting, and professional meetings (up to $2,500/year)
  • Research funds (up to $25,000 per year)
  • Mentor funds (up to $10,000 per year/team)
  • CAPS Award is renewable annually (3-5 years)

59. Benefits Administration

  • Salary
  • Salary is paid through scholars departments
  • (departments cross charge K12 grant)
  • Tuition
  • Full tuition coverage for scholars in MS programs (e-mail Student Accts Receivable page to CAPS Coordinator each semester)
  • Scholars not in MS program apply for Regents Scholarship (non-degree student information and form are posted on CAPS website)
  • Required course textbooks and software are covered by CAPS (SAS forms on CAPS website)

60. Benefits Administration(continued)

  • Travel
  • Complete CAPS Travel Authorization (TA) form (on CAPS website) & submit to CAPS Coordinator prior to travel
  • Check GSA per diem when completing TA (link posted on CAPS website)
  • Complete Employee Expense Worksheet (on CAPS website) and submit with original receipts after travel (internet charges are not allowed by K12 grant)

61. Benefits Administration(continued)

  • Research Funds
  • Complete Research Funding Application (on CAPS website)
  • Complete NIH budget and justification
  • Contact Coordinator re equipment order forms
  • Submit forms electronically to the CAPS Coordinator with IRB approval/renewal letter
  • Include electronic signatures or send a signed hard copy to CAPS Coordinator at EpiCH, 300 WBOB
  • For subsequent year renewal requests, submit NIH budget and justification electronically and the most recent IRB approval/renewal letter

62. Benefits Administration(continued)

  • Mentor Funds
  • Review policy re use of mentor funds (on Mentoring page of CAPS website)
  • Each Scholars team decides how to divide funds
  • Mentor funds may be used for professional travel, continuing education, CAPS research project, or salary redistribution
  • Submit forms to the CAPS Coordinator as early in each budget year as possible

63. MS Program Application

  • Submit choice of MS program to CAPS Program Director for approval
  • Apply to program (see SPH website and Graduate Studies Coordinator for information)
  • Attend the SPH Orientation
  • Maintain contact with Major Coordinator and Advisor
  • Refer to Student Guidebook throughout program
  • Register for course load as outlined in plan
  • Maintain cumulative GPA of 3.5

64. Public Information

  • Scholars name
  • Photo
  • Biosketch
  • Area of study and research interest
  • Disclosed in press releases, program reports, web pages, and similar documents

65. Notification of Changes

  • Scholars are required to immediately notify
  • CAPS Director in writing of:
  • Changes that preclude meeting award requirements
  • Acceptance of similar award with duplicate benefits
  • Changes in course load
  • Changes in clinical responsibilities
  • Changes in teaching load
  • Withdrawal from degree program

66. Leaves of Absence

  • Requires written request to CAPS Program Director
  • Requires approval of CAPS Program Director
  • Maximum, if approved, is 2 months of unpaid absence

67. Clinical Research Shared Support Office of Clinical Research: budget, study staff, clinic space Biostatistics Core: study design, coordination, analysis GCRC:study staff, clinic space Clinical Pharmacology Center: pharmacokinetic and pharmacodynamic studies; pharmacogenetics Mentoring Core: guidelines, training, mentoring issues Scientific Writing Core: grant writing, manuscript preparation and review, presentations IRB: Human Subjects protection, informed consent issues IND/IDE Assistance Program: FDA/IND applications, FDA and industry-related issues Office of General Counsel: legal assistance, negotiating agreements, policy guidance CAPS Website: caps.umn.edu contacts, CR-related links, announcements, forms 68. CAPS Contacts 69. Introductions EpiCH Support Staff 70. CAPS Coordinator Terri Tharp, MPH [email_address] 612-626-8882 71. MS Clinical ResearchMajor Coordinator Andrea Kish, MS [email_address] 72. EpiCH Accounting Keith Coyer CAPS Accountant [email_address] 73. Administrative Support Jill Anderson Administrative Specialist [email_address] Janelle Willard Executive Secretary [email_address] 74. CAPS Questions? CAPS Program Director Russell V. Luepker, MD, MS [email_address] CAPS Co-Director Elizabeth R. Seaquist, MD [email_address] CAPS Co-Director James D. Neaton, PhD [email protected] CAPS Mentoring and Evaluation Director TBN CAPS Coordinator Terri Tharp, MPH [email_address] CAPS Website www.caps.umn.edu