Executive Clinical Leadership Program: Fill & Download for Free

I am going to skip over the “don’t get an online degree” hubabaloo. You already know the stigma associated with that, and we’ll assume you are an adult who has decided that this is the right choice for you:If you absolutely must do online, then Fielding is your best bet for making your life easier. They are currently the only Ph.D. Program that is APA accredited (however see my last paragraph on Cumberlands). They are also INCREDIBLY costly. And the name “Fielding” will automatically signal your colleagues that you received your degree online. The APA doesn’t accredit ANY 100% online programs. Fielding Ph.D.s are required to get one full year of in-residence training, often fairly close to their home location. Cumberlands (below) also requires one full year of in-residence training, and they are working toward APA. EDIT 12/5/17: Cumberlands has now created the Psy.D., also designed to meet APA, and requires THREE years of full time residency on campus, but delivered in the long-weekend format each month. My understanding is that this was done in an effort to make APA accreditation go more smoothly.I think Dr. Anderson’s recommendations are fine as well - however also, expensive.If you get an online Master’s Degree two things are going to be true:Thing 1: Your Ph.D. program is likely NOT going to accept any of those credits. This isn’t just because they are online, it’s because many doctoral programs don't accept transfer credits - there are, however, some that do. You could be taking these classes via a Ph.D. that just gives you an MA or MS en route. Getting a terminal MA or MS in Psychology is unwise and pointless in my opinion.Thing 2: Aside from essentially losing those credits for no reason, if you DO plan to apply to a reputable brick/mortar school, Dr. Anderson is correct that you will likely be turned down. People are surprised to learn that clinical psychology doctorate programs are some of the HARDEST programs to gain admission into (Med School usually accepts about 40% of applicants, but Psych PhDs only accept about 20%). A U-Phoenix degree is not going to look good next to the 100 other candidates applying for the Ph.D. slot. I’m not going to say it’s impossible, by any means, but the odds are stacked against you. If you “touch” online in any way, then you might as well stick with online, or be prepared for lots of “no’s” or “waitlists” from traditional brick and mortar funded/non-funded doctoral programs.OLD INFORMATION: For me, University of the Cumberlands was a great fit. It is extremely intensive as you are cramming what is normally 5–6 years for a Ph.D. into only 4. However, the first year’s theory-based classes (essentially master’s courses) can be done online. These are things like abnormal psychology, history/systems, personality theory, etc. When you come to the campus, you are literally immersed in the clinical courses - CBT, Existential, Psychodynamic, Interviewing, Supervision, Practicum, Personality Testing, Cognitive Testing, Dissertation Proposal… I don’t even think “intense” is the right word. But, it’s a shorter program, it’s much more affordable than many of the other non-funded programs, it is a non-profit school, it is a highly reputable private school that has been around since 1889, it has a large reputable tenured faculty, a psychological clinic, and it permitted me to do the first year of theory-work online. Also, I liked that it was a Ph.D. and not a Psy.D. (personal preference). Like with any other Ph.D. program, you are doing both your own research, as well as research with a faculty member, presenting at state conferences, and you are required to obtain CEUs, as if you were already licensed. All of the faculty are from APA accredited programs, and although the program is too new to apply for APA yet, it is designed to be APA and will pursue accreditation once it has a large enough matriculated body of students.Cumberlands didn’t have the stigma that you mention about online programs. Nor do I think it ever will, if the director remains the same. Our students have landed some APA accredited internships (impressive for a non-APA school) and we’ve had excellent feedback from other psychologists by whom our students have been supervised.UPDATE (12/5/17): The new Psy.D. requires student to obtain a full 3 years of in-person clinical residency, however it is delivered in the executive weekend format. All practica is obviously completed in person, and the fourth (internship) year is also completed in person. There are (as of 2018) some complications with applying via APPIC. Not sure how that will turn out. The program is, therefore, currently best suited to individuals whose states permit independent internship arrangements (for example, my internship was a state psychiatric hospital that is neither APPIC or APA accredited, but has been extremely reputable for training students since the 1930’s). I am hard pressed to agree that you can learn adequate clinical skills in spread-out weekends. It was hard enough doing it in one year of residency + 2 years of practicum. We shall see. I know people who are considering applying to this new model.UPDATE (10/10/2019): The new Psy.D. program is being phased out. As I predicted two years ago, that model does not work with clinical psychology. As the university prefers an executive model, it seems that their direction is more appropriate for Executive D.B.A. programs, or Ed.D. in Educational Leadership programs. Unfortunately, Cumberlands really had a nicely structured program with their in-residence (literally) requirement. I hate to see the program go, because it had forged a very nice reputation within the Appalachian psych community. Sadly, the program was not around long enough to apply for APA accreditation.Schools that offer online or hybrid doctorates are as follows:APA + REGIONALY ACCREDITED + “CLINICAL”Ph.D., Hybrid, Fielding University - Likely Best ChoiceREGIONALLY ACCREDITED + “CLINICAL”Psy.D., Hybrid, Saybrook UniversityPh.D. or Psy.D., Meridian UniversityPh.D., Walden UniversityPh.D., Capella UniversityPsy.D., California Southern University (no federal financial aid)Ph.D., Hybrid, University of the Cumberlands - CLOSEDPsy.D., Hybrid , University of the Cumberlands (working toward APA) - CLOSINGEd.D., Argosy University (Counseling Psychology) - CLOSEDREGIONALLY ACCREDITED, BUT “NON-CLINICAL” **Psy.D., Ashford University (General Only, not Clinical)Ph.D., Grand Canyon University (General Only, not Clinical)Ph.D., Keiser University (General Only, not Clinical)Ph.D., Northcentral University (General Only, not Clinical)Ph.D., California Institute of Integral Studies (Transpersonal Only, not Clinical)Psy.D., Chicago School (International Psychology)Ed.D., Chicago School (Educational Psychology & Technology)Psy.D., Alliant International University (Educational Psychology)Ed.D., Regent University (Educational Psychology)Ph.D., Regent University (Counseling & Psychological Studies)Psy.D., University of the Rockies (Clinical in person, nonclinical online) - CLOSEDNOT REGIONALLY, BUT STATE, ACCREDITED, “CLINICAL” *Ph.D., The Professional School of Psychology (applying for regional) - CLOSINGPsy.D., Ryokan College (currently applying for regional) - CLOSEDNOT REGIONALLY, BUT DEAC ACCREDITED “NON-CLINICAL” *Ed.D., California Coast University (Educational Psychology)* Almost every state requires at LEAST regional accreditation. As such, Ryokan would not likely be a valid choice unless you live in California, where its graduates are (and have) successfully become licensed as Clinical Psychologists.** Some states do not stipulate that your doctorate degree be clinical in nature. You should check with your state board, as some of the “non-clinical” degrees may qualify you to apply as a psychologist. HOWEVER, ethical guidelines may bar you from “practicing” psychology if your program didn’t properly prepare you to “practice.” You would need to document heavily all practicum/internship experiences, mentorships, consultations, etc., otherwise you may be breaking the law even if you get a license to practice, since you essentially don’t know how to practice.MASTERS DEGREES: Argosy, Walden, Capella, Adler, Chicago School, Liberty, California Coast, there are many more. See my above warning about obtaining a terminal masters degree in Psychology, if you plan to obtain a doctorate as well.

The development of medical device starts with the need realized by a physician or surgeon. The device development is usually the result of this need and communication between him and engineer from a medical device supplying company. Although large medical device companies typically develop successive iterations of existing devices, most new device categories are typically developed by venture-backed start-up companies. Typically, a physician and/or engineer inventor conceives of a device solution to an unmet clinical challenge, initiates the patent process, and builds preliminary device prototypes. Preliminary bench and animal testing may be performed using the inventor’s or an acquaintance’s personal funding (angel investors). Further development typically requires engaging a team of engineers who work closely with physician advisors to bring the concept through the “design-build-test-redesign” cycle of bench and animal testing. This preclinical stage typically takes 2 to 3 years and depending on the nature of the device may consume US$10 to $20 million before the device is ready for clinical testing. These capital requirements exceed the means of most angel syndicates and are typically obtained from venture capital firms in the form of equity financing.A small percentage of device ideas are conceived in academic medical centers using federal or other grant funding. Few academic centers have the intrinsic capabilities to develop the device beyond the early prototype stage. Intellectual property is typically out-licensed to an existing company or start-up for further development. To facilitate the development of ideas that emerge out of federally funded programs, Congress passed the Bayh-Dole Act that assigns all intellectual property rights to the academic medical center.Initial Clinical TestingA start-up company’s survival is dependent on reaching milestones efficiently (in terms of time and money) to successfully raise additional funding. First clinical use is perceived by many as a key milestone, so that delays in the initiation of clinical testing programs can threaten a company’s viability. Companies will therefore seek the quickest path to first clinical use. US regulatory requirements are more extensive and require additional time and resources compared with those of other countries. It is estimated that obtaining Food and Drug Administration (FDA) approval to initiate clinical studies in the United States adds 3 to 6 months to the process of device development. In addition, subsequent review by the institutional review board (IRB) at the clinical site can add an additional 3 to 6 months to this timeline. Because of these factors, initial clinical device testing has shifted largely to outside of the United States. It is thus estimated that more than 75% of first clinical use cardiovascular device testing is now outside the United States, saving what may be 6 to 12 months when compared with US clinical initiation. When initial clinical testing is performed within the United States, it is estimated that only 25% of the work occurs at academic institutions. This is due in part to the bureaucracy associated with large academic institutions for both IRB approval and contract negotiations .Clinical testing of an unapproved significant-risk medical device requires FDA approval in the form of an Investigational Device Exemption (IDE). The IDE application provides information to the FDA on device design and qualification, as well as on the study protocol. The FDA is mandated to respond to the IDE application within 30 days.1 An IDE may also be required for studies in which an approved device is used for a purpose distinct from its approved indication.2 This is typically the case when a trial is sponsored by a company for the purpose of expanding the indication of a device or making significant changes in the instructions for use.Regulatory Approval Process (United States)Medical devices are regulated in the United States by the Center for Devices and Radiological Health (CDRH) of the FDA. The FDA/CDRH mandate is to promote and protect the public health by making safe and effective medical devices available in a timely manner. The standard for demonstrating safety and effectiveness is determined in part by the risk associated with the device in question. Devices are classified according to their perceived risk using a 3-tiered system (class I, II, or III).Class I devices (lowest risk) are subject to general controls, which are published standards pertaining to labeling, manufacturing, post-market surveillance, and reporting. Devices are placed into class I when there is reasonable assurance that general controls alone are adequate to assure safety and effectiveness. The general controls that typically apply to class I devices include prohibitions against adulteration and misbranding, requirements for establishing registration and device listing, adverse event reporting, and good manufacturing practices. Furthermore, remedies including seizure, injunction, criminal prosecution, civil penalties, and recall authority are provided to FDA. Formal FDA review is not required for most class I devices before their market introduction.Class II devices are those higher-risk devices for which general controls alone have been found to be insufficient to provide reasonable assurance of safety and effectiveness, but for which there is adequate information available to establish special controls. Special controls may include performance standards, design controls, and post-market surveillance programs. In addition, most class II devices require FDA clearance of a premarket notification application (PMA or 510[k]) before the device may be marketed. In the 510(k) application, the medical device manufacturer must provide data to demonstrate that the new device is “substantially equivalent” to a legally marketed device. Although substantial equivalence can usually be demonstrated on the basis of bench and animal testing alone, approximately 10% of 510(k) applications include clinical data.Class III devices, such as heart valves, pacemakers/implantable cardioverter-defibrillators, and coronary stents, are judged to pose the highest potential risk. These devices are either life-sustaining/supporting, of substantial importance in preventing impairment of human health, or present a high risk of illness or injury. Consequently, general and special controls alone are inadequate to provide reasonable assurance of safety and effectiveness. Most class III devices require FDA approval of a PMA before they can be legally marketed. Approval of the PMA generally requires clinical data demonstrating reasonable assurance that the device is safe and effective in the target population.The Human Device Exemption (HDE) is a new pathway to allow for commercialization of class III devices designed to address small markets, ie, diseases or conditions that affect fewer than 4000 patients in the United States each year. Approval of an HDE requires demonstration that the device is safe and the probable benefits outweigh the probable risks. Although the process may require smaller clinical trials, an HDE device must continue to operate under local IRB approval at each participating institution and must continue to collect case report forms akin to an ongoing clinical trial. The PMA process typically involves a series of studies starting with first clinical use and culminating in a multicenter, prospective randomized control trial (pivotal trial). The complexity and extent of the clinical testing program is dictated by the nature of the device and its proposed use. The clinical study program is developed by the company in conjunction with clinician investigators, all in close collaboration with FDA/CDRH.The first and arguably most important step in this process is the pre-IDE meeting, in which the company, often accompanied by the lead clinical investigator(s), meets with FDA/CDRH to present data about the device, its clinical development program, and its intended use after approval. The FDA/CDRH staff reviews existing bench and animal data (as well as any outside-the-United States clinical data) and makes informal non-binding suggestions regarding the need (if any) for additional pre-clinical data (bench and animal), as well as the study design. The sponsor then submits an IDE application to FDA/CDRH (Medical Devices) for formal review.Clinical development of a new class III device is typically divided into pilot and pivotal trial phases. The purpose of the pilot phase (starting with first clinical use) is to establish safety and to assist in design of the pivotal trial. Pilot-phase testing is typically limited to fewer than 100 patients treated at a few centers. The purpose of the pivotal trial is to generate data that define patient populations in which use of the device is safe and effective. The dialogue initiated during the pre-IDE meeting continues and intensifies between FDA/CDRH and the company over the specifics of the pivotal trial and includes the patient population, the control group against which the new device will be evaluated, and the primary and secondary end points of the evaluation. For first-in-class devices, eg, drug-eluting stents, where there are few data regarding short- or long-term outcomes, FDA/CDRH requires prospective randomized controlled studies. Though high profile, devices that require randomized data for approval are the exception rather than the rule. The vast majority of device clinical trials are case series that carefully document product performance. Still more products are approved as “tools.”Most devices currently in testing are similar to well-characterized approved devices, eg, next generation bare metal stent, angioplasty balloon, etc. When FDA/CDRH has substantial data on the device class metrics, comparisons may be made to historical data or objective performance criteria. When few data on existing standards are available, the FDA typically requires randomized rather than single-arm studies, in which the new device is compared against concurrent controls treated with current best medical practice. That comparison may be powered to show that the new treatment is superior to prior approaches, or that it is non-inferior (equivalent or better) compared with a previously approved device in a new area. The issues relating to the type of trial are discussed below.The specifics regarding study design may have profound impact on the time and cost of bringing a new device to market. Though the primary mission of the FDA/CDRH is to ensure safety and effectiveness of commercially available devices, when exerting regulatory oversight the agency must balance its primary mission with the costs of introducing new technologies to the clinical marketplace. This has been codified by the FDA Modernization Act and the FDA Modernization Act-II, which require the agency to pursue the “least burdensome means” available to establish device safety and efficacy. Although surrogate end points, eg, angiographic restenosis rather than recurrent cardiac events, may be allowed as secondary end points, the primary end point of a pivotal trial for a first-in-class class III (Classify Your Medical Device) device is usually a clinical end point (or a well-established surrogate such as infarct size in a myocardial infarction treatment device). Depending on the end points negotiated, such pivotal trials may require enrollment of 1000 or more patients at 30 to 50 sites over a period of 1 to 2 years, with appropriate follow-up frequently to 1 year after treatment. The trial must be conducted according to good clinical practices standard, with the approval of the local IRB at each participating center.Clinical Site (IRB, Contract, Conflict of Interest)Once the FDA/CDRH has approved the IDE, the sponsor must formally recruit as many as 50 sites to ensure patient enrollment in a timely fashion. Each site has its own rules regarding participation in clinical studies, which typically can be divided into 3 components: Human research, contract, and conflict of interest.Every clinical site is federally mandated to have an IRB responsible to ensure the protection of the rights, safety, and welfare of research subjects. Regulation of the IRB review of protocols involving medical devices is under the purview of the FDA. The Office of Protection From Research Risks (OPRR) is responsible for oversight regarding all human research and is in direct communication with the FDA/CDRH. Studies involving human subjects that do not involve products regulated by the FDA fall under the direct purview of the OPRR. Both the FDA and the OPRR are in the Department of Health and Human Services. Each IRB must meet standards for the composition, leadership, and processes set forth by that department. IRBs are subject to periodic audits by the FDA to ensure that records and procedures are in compliance with regulations.Working with the sponsor, the principal investigator prepares an application to the IRB at his/her institution that includes the consent form describing in lay language the device, the proposed clinical study, the inclusion and exclusion criteria for the trial, and a draft consent form describing the risks and benefits of participation in the study. The IRB then formally reviews the application and frequently requests changes, particularly to the informed consent. The IRB process typically requires approximately 3 months, but at times can take considerably longer.The company must also negotiate agreements with each clinical site addressing the many issues associated with the clinical trial. In addition to the study costs/reimbursement (per-patient enrolled and overhead), these agreements typically include indemnification and the assignment of ownership rights of new discoveries (intellectual property) made in the course of the study. The resources required at each center to perform the high quality research necessary for a PMA protocol are formidable. In addition to resources required to maintain an excellent clinical program (physician, nursing, and technical staff coupled with state of the art facility), the study center must dedicate additional resource, primarily research nurses to perform high-quality clinical research. The role of the research nurse is critical to all phases of the trial, including general study management, IRB process, patient recruitment, and accurate completion of case report forms. The sponsor is responsible for accrediting each clinical site to document that the necessary resources are in place to fulfill the demands set forward in the protocol. The clinical research staff do not provide clinical care and are thus not part of the hospital’s salaried clinical nursing staff. The per-patient costs include all additional charges the patient incurs for the study, including procedures (therapeutic and diagnostic), clinic visits, and diagnostic studies, as well as research nurses’ salaries. It is estimated that it takes 3 to 6 months to formally recruit each clinical site.Device development from the earliest stages requires active involvement of practicing clinicians. Clinician/inventors are frequently involved in creation of the device concept and are often integral members of the design team performing the majority of the early animal studies. Through this involvement, the clinician/inventor obtains intimate knowledge of device performance and failure modes. Safety concerns during first clinical use and pilot phase mandate participation by these clinician/inventors. The clinician/inventors frequently take leadership roles and have equity positions in the company developing the device. These interests present important conflicts of interest which must be addressed to ensure patient safety, data integrity, and public trust in the process. Many institutions have set up formal processes to address these conflicts of interest, potentially adding more time to the institutional recruitment process.Pivotal studies required for a PMA application are typically large multicenter randomized trials and often represent the largest commercial risk and expense in the device development process. In addition to obtaining an IDE from the FDA and formally recruiting clinical sites, the sponsor must also put into place an extensive infrastructure that typically includes engaging a contract research organization (CRO), core laboratories, formation of a data safety monitoring board (DSMB), and an executive committee. The CRO provides the infrastructure required to recruit, qualify, and audit sites. Core laboratories evaluate primary data, eg, angiography, ECG, and ultrasound results, in a uniform and blinded manner. An executive committee is typically composed of the clinician investigators, company representative, CRO, and core laboratories. The DSMB, composed of a group senior clinical investigators and statisticians with no other involvement in the study, periodically reviews trial data at specified intervals. The DSMB has the mandate to stop or modify a study, eg, discontinue randomization to one of the groups if complications associated with the study device are in excess of anticipated rates, if differences between study groups reach statistical significance, or if further patient enrollment will not impact study outcome.Regulatory Approval Process (European Union)Though there are many similarities in the regulatory process in the United States and countries within the European Union, there are important differences that impact the time and cost associated with the introduction of a new medical device.I have identified 3 illustrative examples: Use of notified bodies, criteria for approval, and local site (IRB/site negotiation).The European Union system relies heavily on notified bodies (NBs), which are independent commercial organizations to implement regulatory control over medical devices. NBs have the ability to issue the CE mark, the official marking required for certain medical devices. NBs are designated, monitored, and audited by the relevant member states via the national competent authorities. Many functions performed by the FDA/CDRH within the United States are performed by NBs, including medical device certification, device type designation, assessment and verification of quality systems, and review of design dossiers for high-risk devices. Currently, there are more than 50 active NBs within Europe. A company is free to choose any notified body designated to cover the particular class of device under review. After approval, post-market surveillance functions are the responsibility of the member state via the competent authority. NBs typically function in a closed manner, providing little visibility on criteria required for approval. This dynamic allows for a high degree of variation as well as competition among NBs. As a result, NBs are perceived by industry to be less bureaucratic organizations that can respond more quickly and efficiently than the FDA. These potential benefits may be offset by a system that is intrinsically more fragmented and highly variable and has resulted in the approval and continued marketing of devices, eg, abdominal aorta stent grafts, in Europe that failed efficacy trials in the United States.Criteria for approval of high-risk devices are different in the European Union. To receive approval to market a class III high-risk (and some class II) device in the United States, the manufacturer must demonstrate the device to be reasonably safe and effective, which typically requires a prospective, randomized controlled clinical trial. To receive approval to market a device in the European Union, the manufacturer must demonstrate that the device is safe and that it performs in a manner consistent with the manufacturer’s intended use. This difference has a profound impact on the size and scope of the clinical studies for regulatory approval. This significant difference is illustrated by examining the introduction of distal protection systems. The GuardWire developed by PercuSurge, Inc (later acquired by Medtronic) is a specialized coronary guidewire with an elastomeric balloon mounted at the tip. During an angioplasty/stent procedure, the operator crosses the lesion with the GuardWire and inflates the balloon. Stent placement is then performed, after which a specialized catheter is used to evacuate any arterial debris that may have become dislodged during the procedure. The GuardWire balloon is then deflated. Demonstration of safety and performance, ie, ability to aspirate material during the stenting procedure, was demonstrated in a 22-patient single-arm study. In contrast, in the United States, this device was designated class II (requiring 501[k] clearance and clinical data). To satisfy US criteria for clearance, the standard of safety and effectiveness required in this case was defined as the ability to reduce complications associated with stenting of saphenous vein grafts. To meet this criterion, an 800-patient multicenter trial randomized trial comparing distal protection to usual care (no protection) was performed. At 30 days, a 42% relative reduction in major adverse cardiac events (primarily myocardial infarction) was observed. A trial of this type is estimated to cost US$10 to $12 million and may take 24 months to perform.

Common Resume ObjectivesI am seeking employment with a company where I can use my talents and skills to grow and expand the company.I want to succeed in a stimulating and challenging environment, building the success of the company while I experience advancement opportunities.I want to excel in this field with hard work, perseverance and dedication.I want a highly rewarding career where I can use my skills and knowledge to help the company and my coworkers be successful.I am seeking a company where I can use my experience and education to help the company meet and surpass its goals.I want to be part of the success in an environment of growth and excellence.I am seeking a competitive and challenging environment where I can serve your organization and establish an enjoyable career for myself.Resume Objectives: Specific to the JobAdministrative assistant - I am seeking a position in the travel industry focusing on sales, customer care and office management.Education - I am a dedicated person who wants to use her skills and education to help students achieve using both traditional and modern approaches.Education administration - I want to obtain a position as a program director within an adult education setting.Engineering - I want to share my high level of skills on most machines and work on automobiles or electronics.Executive management - I am seeking a senior position in the financial services industry focusing on operational management and process improvements.Financial - Secure a position with a leading organization that will lead to a long term career relationship.Manager - Seeking a position with a well established company where I can maximize my program development and training skillsMarketing - I am looking for a position in marketing where I will use my skills and experience in SEO and social media to increase site traffic and propel your company’s growth.Mechanical engineer - I want to use my many years of experience to carry out my tasks with efficiency, professionalism and cost effectiveness.Medicine - Seeking a position as a clinical practice assistant using my skills in research and leadershipReceptionist - I am looking for a receptionist position where I will use my skills in data entry and switchboard as well as my experience with Microsoft Office and Excel.Retail Manager - I am looking for a management position with a growing company where I can apply my experience to increase the company’s reputation and profitability.Sales - I am seeking a position as sales associate with a fast-growing company.Technical - I am looking for a position as a project manager for a software or internet company.University professor - Seeking a position as a law professor with a focus on real estate and land use lawRead more at Examples of Resume Objectives