Graduate Certificate Programs in Clinical Research Management
Clinical research graduate certificate programs are academic training programs that provide instruction in the design, implementation, management, and analysis of clinical trials in which pharmaceuticals and medical devices are tested on human subjects. These programs typically consist of a small cluster of graduate-level courses offered by schools of health and medicine at accredited colleges and universities. They are designed for college graduates and mid-career professionals who hold a minimum of a bachelor’s degree, including students who hold master’s and doctoral degrees.
The courses that comprise a clinical research graduate certificate program are generally also part of the curriculum for a school’s master’s program in clinical research. As such, some or all of the credits earned in a certificate program may transfer to a school’s master’s program in clinical research for students who decide to pursue a master’s degree in the future. In addition, certificate program curricula are typically designed to assist students in preparing for the clinical research professional credentials administered by the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA). While typically not required to work in the field of clinical research, these professional certifications (which are distinct from a graduate certificate) may help in the job market for individuals looking to change careers.
Thus, clinical research graduate certificate programs represent a relatively direct and affordable pathway to entering the field of clinical research, as well as a means of advancing in the profession, without having to enroll in a full master’s program.
Clinical Research Explained
Clinical research refers to the process by which biotechnology firms, pharmaceutical companies, and independent medical research organizations develop and test medications, biologics, and medical devices through formal clinical trials that ensure safety and efficacy. The clinical trials process is complex. It must adhere to strict governmental regulations regarding experiments that involve human subjects and meet scientific evidentiary standards for experimental design, reliability, and reproducibility. While medical doctors and scientists with doctoral credentials typically oversee clinical research, they are assisted in this by trained professionals tasked with managing the actual clinical trials, including selecting and coordinating with clinical sites (e.g., research centers, hospitals, clinics), working with principal investigators to enroll patients, managing resources and timelines, conducting site visits, ensuring clinical data is being recorded and stored properly, working on submissions to the Federal Drug Administration (FDA), collecting and storing patient samples if applicable, and much more.
The field of clinical research thus employs a range of professionals* who are trained in areas like biostatistics, epidemiology, statistical computing, clinical site monitoring, lab safety, regulatory affairs, and other areas pertinent to medical, biological, and pharmacological research. This includes: Clinical Research Coordinators, often Clinical Nurse Research Coordinators (CNRC) with training in nursing and Registered Nurse (RN) licensure; Clinical Research Associates (CRAs), who are required to hold a minimum of a bachelor’s degree in a health sciences or related field and have at least two years of clinical experience; and Regulatory Affairs Associates or Specialists, who must also have a bachelor’s degree and typically several years of experience in biotechnology or the pharmaceutical industry.
Identifying and Classifying Clinical Research Management Graduate Certificate Programs
Graduate certificate programs are career-oriented academic training programs that culminate in the conferral of a certificate rather than a degree, and they consist of fewer course requirements than master’s or doctoral degree programs in the same field. Clinical research graduate certificate programs are non-degree programs offered by accredited colleges and universities that provide narrowly focused training in the knowledge and skills required to work in clinical laboratories where human research trials are conducted on pharmaceuticals, biologics, and/or medical devices. These programs offer a curriculum covering topics in the principles and ethical practices of clinical research, data acquisition and analysis for clinical trials, experimental design and implementation, and the management of clinical operations. This curriculum typically consists of fewer than ten courses (four, five or six courses is common) that can be completed in one year or less and that address subject areas pertinent to establishing qualifications to work for companies conducting clinical trials and to apply for ACRP and/or SOCRA professional certification credentials.
In addition, and of equal importance, clinical research graduate certificate programs are designed for students who have already completed a bachelor’s degree, including mid-career professionals, and are also open to students who hold a master’s or doctoral degree. These programs can be designated as graduate, post-graduate, or post-baccalaureate certificate programs in clinical research, clinical research management, or clinical research administration. Some graduate certificate programs require students to hold a master’s degree; these programs are generally designated as post-master’s certificate programs in clinical research. All of these programs, regardless of their formal name, can be classified as graduate certificate programs in clinical research, provided they offer a curriculum that is designed to prepare students to work in the field of clinical research, as detailed in the section below.
Clinical Research Graduate Certificate Courses
While specific course requirements, course names, and course descriptions vary by school and by program, graduate certificate programs that are designed to prepare students for work and professional credentialing in clinical research and management typically provide training and instruction in the following areas: clinical trial phases and design; clinical research methodology and medical literature; data collection and analysis in clinical research; and clinical laboratory regulatory and compliance issues. Indeed, the curriculum of graduate certificate programs in clinical research generally aligns with core knowledge areas outlined by the ACRP in its preparation guidelines for the Certified Clinical Research Associate (CCRA) credential. These include:
- Scientific Concepts and Research Design
- Ethical and Participant Safety Considerations
- Product Development and Regulation
- Clinical Trial Operations and Good Clinical Practices
- Study and Site Management
- Data Management and Informatics
Thus, a graduate certificate in clinical research typically requires students to complete between four and six courses that incorporate didactic lectures, case studies, readings, and literature reviews that cover most or all of the topics listed above. The courses listed below are drawn from actual clinical research graduate certificate programs and offer a representative overview of a typical program curriculum.
- Introduction to Clinical Research Methods
- Design and Conduct of Clinical Trials
- Clinical Trial Planning and Implementation
- Critical Evaluation of the Medical Literature
- Regulatory Compliance and the Protection of Human Subjects
- Clinical Research Data Management and Analysis
Online Graduate Certificate Programs in Clinical Research Administration
Online graduate certificate programs utilize distance-learning technologies to offer all or most of their required coursework via online instruction. These programs provide the same type of training and instruction as traditional, campus-based programs, but do so in a more flexible and convenient format that does not require students to relocate and/or to commute to a school’s campus for classes. Some clinical research graduate certificate programs are 100% online and do not require students to attend any campus-based sessions. Other programs incorporate a limited number of campus visits into their curriculum and use these sessions for orientations, seminars, workshops, and hands-on experiential learning. Campus visits, sometimes referred to as intensives or immersion sessions, are typically short in duration (three to five days), and can enhance an online program by giving students the opportunity to interact with their course instructors and peers. However, these visits do require travel and may be inconvenient for some students. Graduate certificate programs that require more than two to three campus visits are classified as blended or hybrid online programs by GraduateCertificates.com and may not be a practical option for students who do not live or work within commuting range of the school offering the program.
Recent college graduates and mid-career professionals who are considering an online graduate certificate program in clinical research should note that there are two general modes of online instruction: synchronous instruction and asynchronous instruction. Synchronous instruction offers an online experience that is similar to learning in a traditional classroom setting, as lectures and virtual class sessions are streamed live and delivered in real-time to students via the internet. Asynchronous instruction does not have a real-time component and encompasses a broad range of learning and instructional activities that can be accessed 24-7 by students, such as pre-recorded lectures and learning modules. While all online programs have asynchronous elements, not all programs incorporate synchronous live instruction.
Both modes of online instruction have been found to be effective. Students who prefer a more rigidly structured learning experience may want to explore programs that utilize synchronous instruction. Students who feel they would benefit from greater scheduling flexibility may prefer programs that offer all of their coursework via asynchronous instruction, although asynchronous instruction typically requires students to exercise more self-discipline and self-motivation to stay on top of the largely self-guided curriculum.
Examples of Online Graduate Certificates in Clinical Research Management
The programs detailed below provide a representative overview of graduate certificate programs in clinical research that are currently offered in an online format.
The University of California, Berkeley (UC Berkeley) offers an online Graduate Certificate in Clinical Research Conduct and Management program through UC Berkeley Extension. The program gives students a choice between taking all of its four required courses online or opting for a hybrid format in which students attend roughly half of their classes at the school’s campus. The 12-credit program has a one-year completion time and does not require students to attend any campus visits. To qualify for the program, students must hold a bachelor’s degree from an accredited college or university. For more information on the program, visit UC Berkeley Extension at extension.berkeley.edu.
The Massachusetts College of Pharmacy and Health Sciences (MCPHS), a private, non-profit medical and health sciences school in the Boston area, offers an online Graduate Certificate in Clinical Research program. The program is designed for students who hold a bachelor’s degree and who have professional experience in a research field. Students in the program are required to take three courses for nine graduate credits and can complete the program in two semesters without having to attend any on-campus sessions. For more information on the program, visit MCPHS at www.mcphs.edu.
The George Washington University (GW) offers several graduate certificate programs in clinical research, including an online Graduate Certificate in Clinical Research Administration program. The program is 100% online and does not require any campus visits. Students in the program must complete five core courses and one elective, all of which are part of a Master of Science in Health Sciences (MSHS) in Clinical Research program offered by GW. The 18 credits earned in the Clinical Research Administration graduate certificate program can be transferred to the MSHS degree program at a later date, should a student opt to enroll in the master’s program. The certificate program has an 18-month, part-time completion plan. It requires applicants to hold a bachelor’s degree and have some previous experience in a healthcare field. For more information on the program, visit the GW School of Medicine & Health Sciences at healthsciencesprograms.gwu.edu.
More Graduate Certificates in Clinical Research Administration
*In addition to Clinical Research Coordinators, Clinical Nurse Research Coordinators, Clinical Research Associates, and Regulatory Affairs Associates, there are also professionals who work in adjacent fields that are related to clinical research. These include Medical/Clinical Laboratory Scientists (MLSs/CLSs), who must have a bachelor’s degree and specialized academic and clinical training in medical laboratory science; and Medical/Clinical Laboratory Technicians/Technologists (MLTs/CLTs), who can enter the field after completing an associate degree program in laboratory science. Individuals looking to enter these careers should look for programs that provide specific training in laboratory science as opposed to a graduate certificate program in clinical research.
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