The National Institutes of Health (NIH) Roadmap is a series of recent initiatives

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1 The basic responsibilities of clinical research professionals (CRPs) serve to help establish the objectives of a wide range of education and training programs. Tom Arant, MBA, MSHS, PhD Soo Bang, MS Paul Boepple, MD Laurie Halloran, BSN, MS, CCRA, James L. Parmentier, PhD Amy Sauer Greg Koski, PhD, MD, CPI Advancing Your Clinical Research Career Through Educational Opportunities The National Institutes of Health (NIH) Roadmap is a series of recent initiatives designed to cut across traditional silos of biomedical research. One of its themes, Re-Engineering the Clinical Research Enterprises, focuses on improving the breadth and efficiency of clinical research ( This effort hopes to develop a cadre of clinical researchers with skills that match the increasing complexity and needs of the research enterprise. Several well-publicized safety incidents in recent clinical trials have also caused the pharmaceutical industry to emphasize the need for clinical research professionals to be well trained. The convergence of these two factors suggests that this is an appropriate time to review educational opportunities available to clinical research professionals (CRPs) who wish to advance their careers. CRP Skill and Knowledge Sets The basic responsibilities of CRPs serve to help establish the objectives of a wide range of education and training programs. These objectives include: Employing principles of good clinical practice to produce valid data; Understanding the fundamentals of randomized clinical trials; Ensuring that ethical principles are upheld in human studies research; Understanding regulatory processes and procedures; Using statistical methodology to design, implement, and assess clinical research; Communicating effectively, both orally and in writing. Educational and training programs for CRPs encompass a wide spectrum of offerings and utilize a variety of styles and formats (see Table 1). CLINICAL RESEARCH CAREERS Pre-Baccalaureate and Baccalaureate Programs In recent years, academic programs that focus on clinical research have emerged at the pre-baccalaureate and baccalaureate levels. Institutions that offer such programs are distinguishable by their institutional accreditation, which indicates that the school has met stated educational criteria and has the resources necessary to achieve its stated purposes. By periodically undertaking peer reviews, the accrediting body can establish if the institution continues to offer appropriate programs and gives reasonable evidence that it will do so in the future. Many programs in this category are members of the Consortium of Academic Programs in Clinical Research ( 19

2 Table 1. Clinical Investigation Training Opportunities and Formats Education and Training Opportunities Pre-Baccalaureate and Baccalaureate Programs Specialty Courses Certification Courses Certificates of Advanced Study Master of Science Degrees MD and PI Training Examples of pre-baccalaureate and baccalaureate programs are those at George Washington University (GWU) School of Medicine & Health Sciences. Pre-baccalaureate certificates and baccalaureate degrees are available for nurses and U.S. Armed Forces military personnel with experience in medical technologies and procedures. Other pre-baccalaureate programs in the U.S. include those at Durham Technical Community College, Gateway Community College, and Rochester Community and Technical College, all of which offer basic curricula in clinical research. Programs such as these provide pathways to entry-level positions in clinics and laboratories in healthcare centers, as well as to continued baccalaureate studies and degrees. Beginning in the fall of 2007, students at GWU will be able to participate in an accelerated combined bachelor s/master s program. Educational Styles and Formats Traditional Classroom-Based Directed Reading Directed e-learning Self-Directed e-learning On-the-Job Training/Coaching and Mentoring Similar programs are available or under development both in the U.S. and in European Union countries. Graduate Education Two levels of graduate learning in clinical investigation are available. Certificate of Advanced Study (CAS) programs offers core curricula reflecting basic CRP skills and knowledge sets. Master of Science (MS) programs offer a breadth and depth of training that go substantially beyond the core subjects. Table 2 presents logistic and administrative details for six representative U.S.-based certificate and MS programs, gathered from the respective websites of their parent institutions. Additional programs are listed in the December 2006 issue of Applied Clinical Trials ( com/appliedclinicaltrials). Certificate programs are particularly useful for persons who wish to add clinical investigation skills to their existing specialty training, or who wish to enter the field from some other discipline. Examples are nurses who want to conduct clinical research and venture capitalists who want to advise corporate biotech and pharmaceutical industry clients. Certificate programs are also of great value to career changers and to those who have left the field or the workforce for some time and need to update their professional skills. For recent college graduates with no pre-existing skill sets, the certificate can prepare them for a variety of entry-level positions in clinical research. The Johns Hopkins Bloomberg School of Public Health has had a Clinical Investigation Program for physicians in place at the doctoral level for more than a decade, and the University of Colorado grants a Clinical Sciences PhD degree to qualified persons who have already earned a graduate healthcare or professional degree (i.e., physicians, MSPH graduates, biostatisticians, epidemiologists, nurses, pharmacists, and dentists). However, most programs remain focused at the MS degree level. The MS degree offers broad exposure and considered perspective, as well as opportunities for focused study of student-selected clinical research topics. It also provides a historical and global con- Table 2. Representative Clinical Investigation Graduate Programs Approx. Years to MS Credits Cost per Cost of MS Full- Part- Site Cert. MS Credit Degree Time Time Online MGH Institute of Health Professions $800 $28, Yes George Washington University School of Medicine $485 $17, Yes Boston University $845 / $891 1 $32, No Drexel CROM $1,010 $36, Yes New York University College of Dentistry $1,080 $54, No Eastern Michigan University $396 / $16 29, No 1 Summer-quarter versus winter-quarter tuition. 2 In-state versus out-of-state tuition. 20 MONITOR SEPTEMBER 2007

3 text for a field that is international and rapidly changing. The core knowledge components of the MS degree programs are generally comparable, including (a) understanding clinical trial design or its analysis, (b) using statistics and/or data management, (c) ethical considerations pertaining to human studies, and (d) regulatory, law, or health policies pertaining to drug or device development. The electives of the MS programs may differ considerably, depending on the focus of the parent institution. Each of the MS programs listed in Table 2 also requires the completion of hands-on learning experiences, or preceptorships, in clinical research. These field components may be carried out, for example, in corporate or government settings, in an institutional review board, in a contract research organization, or in a hospital. They provide opportunities for students to see the pace and procedures of real-world clinical science and to begin building professional networks. Most MS programs also require the completion of some form of scholarly research project. Some companies will help pay tuition expenses for their employees, but the costs of an MS degree in both money and time can be high, particularly if students hold full-time jobs or have significant family responsibilities. Physician and Investigator Training Two categories of NIH-sponsored clinical research training are available for physician investigators. Physicians in clinics or academic medical centers wishing to increase their competitive chances for funding of projects of their own interest may be eligible for NIH Career Development Awards in the K (training) series. The NIH K Kiosk provides administrative information about these awards. Physicians wishing to serve as investigators in corporate- or governmentsponsored research at their home institution can take advantage of many NIH-sponsored educational programs and much clinical trial support infrastructure. In either instance, the sponsoring organization, whether it be from industry or government, is interested in Both physicians and nonphysicians can take advantage of certification processes that formally recognize that an individual meets identified standards of competency regarding knowledge, skills, and behavior. providing appropriate training so that clinical studies will be well designed and properly executed at the research site. In parallel with NIH Roadmap efforts, academic health institutions have developed their own training programs for physician researchers. The Clinical Research Program at the Massachusetts General Hospital includes an Education unit, an Information Management unit, a Clinical Trials and Industrial Relations unit, a Clinical Research Support Office, and an Epidemiology, Outcomes, and Disease Management unit, all under the supervision of the NIH-supported General Clinical Research Center (GCRC). Over the next five years, NIH will replace existing GCRC programs with Clinical Translational Science Awards to provide the academic home and integrated resources needed to develop and support well-trained investigators. The first 10 of these institutional awards have been made, and the list is expected to reach 60 institutions by Certification Courses Both physicians and nonphysicians can take advantage of certification processes that formally recognize that an individual meets identified standards of competency regarding knowledge, skills, and behavior. Certification formally recognizes that an individual meets identified standards of competency regarding knowledge, skills, and behavior. The ACRP academies offer professional development courses and certification courses specific to job function, such as Good Clinical Practices (GCPs) for Clinical Research Professionals, and Fundamental and Intermediate Seminars in Clinical Research. Certification Exam Review programs for CRAs, CRCs, and CPIs are available. The exams themselves are multiple-choice tests offered two times a year, and taking the exam requires at least two years of clinical research experience. The resulting certification is valid for two years, and a public registry of certified CRPs is maintained. ACRP recently introduced a Core Knowledge Assessment examination to test fundamental knowledge of ICH GCP clinical research principles for those with less than two years of experience. Fee-based certifications for study site and sponsor investigators are available through an Academy of Pharmaceutical Physicians and Investigators (APPI) program that trains physicians to be a Certified Physician Investigator (CPI ). This certification designates that a physician possesses sufficient knowledge to conduct a safe and ethical clinical trial in accordance with the appropriate ethical, medical, scientific, legal, and regulatory standards. It is granted in recognition of documented education, training, and experience as (1) a primary, sub-, or coinvestigator or as (2) a monitor, supervisor, or designer of clinical trials. It is based upon the successful completion of a written examination, and can be renewed every two years ( org/file.php?id=certification+info). Specialty Courses Specialty courses ranging from half-day workshops to several days of focused study, as well as courses taught in a distance-learning format, are mostly coordinated by for-profit companies and offer topics of current interest to the pharmaceutical or medical industry. Onsite specialty courses can be expensive, even if offered by a nonprofit provider such as ACRP. They may cost $1,500-$3,000 for a two-day session, plus transportation and housing. 21

4 Speakers at medical specialty meetings and industry conferences are usually key opinion leaders who have been invited to speak by committees within the specialty. They generally are responsible contributors to their specific fields. Some offerings may be commercial in nature. Specialty courses are also available in a directed-learning environment. Career Planning To decide the right educational program to pursue you must do some serious career planning. What are your current job prospects? Do you like that job, and want to do more of it? Would you like to do something different? Do you need immediate advancement, or can you take time to prepare your next career move? What are your present skills? What job would you like to have in two to five years? What is a strategic career move? Do you need more understanding of your present responsibilities or more breadth of experience in your chosen field? Could you rotate or volunteer in your present company to get exposure to additional clinical research responsibilities? Do you travel a lot? Are your working hours flexible? Will your employer pay for further training? Can you afford the time and the expense of further training? What other life commitments compete for your educational training time? Each of these questions will be important to answer before moving forward, and can form the basis for an excellent career roadmap for you. Educational Formats The basic formats of clinical investigation education were listed in Table 1. Classroom-based, instructor-led learning offers personal guidance on difficult topics by credentialed faculty. It provides a high level of interaction, in the form of discussions, presentations, and exchanges among a readily available cohort of peers. Students achieve high competency and retain high-level material taught in this environment. It can be expensive, and it involves residency near the institution. Directed reading, in which the student works independently with textbooks, journals, and the web, can provide inexpensive information written by persons with verifiable credentials. However, it involves one-way communication with few opportunities for asking questions or resolving confusion. This format is typically used by experienced professionals who have a good infrastructure and support system, such as a physician in residency studying for licensure. Directed e-learning uses the internet to provide a two-way exchange of education with testing and feedback on learning progress. There are opportunities for discussions, questions, and exchanges both among students and between faculty and students through the use of videos, chat rooms, wikis, and white boards. Directed e-learning is available anywhere there is an internet connection, and provides ready access to timely information, such as recent journals or FDA websites. It affords great flexibility, and is particularly adaptable to individual learning techniques. Asynchronous coursework means students need not be online at the same time. There are no residency restrictions, no dress codes, no commutes, and no distractions. On-the-job training, coaching, and mentoring are extremely attractive options that persons should seek out early in their careers. Directed e-learning allows for differences in learning rates and skills. It offers a definite advantage to quiet individuals who find themselves submerged in a wider classroom of more vocal students. Online discussions often involve more considered and more researched commentary. There are some important negative aspects to directed e-learning. It has an established record of higher dropout rates. It requires focus and self-motivation, and students run a risk of feeling isolated. There is a high premium on written communication skills, on textbased learning skills, and on computer literacy. In addition, the instruction can be as expensive as instructor-led classroom training. It requires a certain level of technological investment and the capability to set up and fix your own computer. Within an industry environment, this may not be difficult. If done from home, it may become expensive. Self-directed e-learning uses commercially available software and web-based tutorials to guide student learning. Good examples include the Collaborative IRB Training Initiative (CITI) and other regulatory certification programs offered by the University of Miami s Miller School of Medicine, which have become wellaccepted as minimum standards for HIPAA requirements, GCPs, responsible standards of research, and HIPS training ( CITI_INFORMATION.htm). Self-directed e-learning programs allow students to proceed at their own rate, but they emphasize rote or repetitive learning. In addition, there is little the student can do to verify program author credentials. On-the-job training, coaching, and mentoring are extremely attractive options that persons should seek out early in their careers. They tend to be focused, but have high-value content, are inexpensive, and can be presumed to be of recognized value to your current employer. Internal corporate trainings range from entry-level background and refresher courses (e.g., GCP, SOP, operations) to extended internships, mentoring, and co-visit programs in which one learns both technical skills and the more challenging soft skills of corporate and interpersonal interactions. The disadvantage, of course, is that you must have the job first. Moreover, there may be a high level of competition for only a few slots because enrollment selections are commonly made by upper management. Finally, this training may offer you little developmental potential if your career goals lie in some other direction. Summary Advancing in your chosen profession is one way to set yourself apart from oth- 22 MONITOR SEPTEMBER 2007

5 ers in your field. It can increase your confidence level in performing your current responsibilities, and it can prepare you for new job opportunities, either with your present employer or with a new one. Your task now is to obtain the most up-to-date information you can, continue to network with both your peers and your mentors in and around your current position, and consider the best next step for your own career goals. Acknowledgment This article summarizes workshop discussions that took place at the 2007 ACRP Global Conference. Tom Arant, MBA, MSHS, PhD, is a consultant with more than 20 years of combined senior management experience in health services and clinical research. He is currently completing an MPH degree at the University of Massachusetts. He holds numerous certifications in health economics, clinical research, and healthcare management. Soo Bang, MS, is director of an investigator-initiated research specialty team for Pfizer. Among other past positions, she was the senior director of the New York City Health and Hospitals Corp. s Office of Clinical & Health Services Research. She also is an adjunct professor at The George Washington University School of Medicine s Clinical Research Administration program. She is president of the New York Metropolitan Chapter of ACRP. Paul Boepple, MD, is former director of the Graduate Program in Clinical Investigation at the MGH Institute of Health Professions in Boston. He is a pediatric endocrinologist on the faculties of MGH and Harvard Medical School. He has served as principal investigator on both NIH and FDA grants related to disorders of growth and pubertal development. Laurie Halloran, BSN, MS, CCRA, is founder and president of Halloran Consulting Group, Inc. She is an active instructor with ACRP and the Drug Information Association, and is on the faculty of Boston University School of Medicine, where she is responsible for School of Graduate Medical Sciences programs on GCPs, design and conduct of clinical trials, and managing clinical investigations. She sits on the Global Educational Committee of ACRP and is the president of the ACRP New England Chapter. James L. Parmentier, PhD, is associate director of the Graduate Program in Clinical Investigation at the MGH Institute of Health Professions and chairman of the Consortium of Academic Programs in Clinical Research. He teaches courses in applied clinical investigation and pharmaceutical project management, and supervises the MFE component of the Institute s MS degree program. He also works with the International Health Organization to develop and implement training programs in HIV/AIDS care and management for physicians and nurses in South Asia. He can be reached at jparmentier@mghihp.edu. Amy Sauer has worked in research for more than seven years. She began as a research assistant working on injury prevention research for UCLA School of Public Health and spent more than three years working as a study coordinator in clinical trials. Currently she works as a clinical research associate for Cell Therapeutics, Inc. in Seattle, Wash., while completing her master s degree through George Washington University's distance learning program. She can be reached at Asauer@ctiseattle.com. Greg Koski, PhD, MD, CPI, is APPI president-elect and vice president for ethics and professional conduct, and a member of the ACRP Board of Trustees and Committee on Government Affairs. Formerly director of the Office for Human Research Protections, U.S. Department of Health and Human Services, he is now associate professor of anesthesia and senior scientist at the MGH Institute for Health Policy, Harvard Medical School. 23