Online Master’s in Clinical Research Administration (CRA) Degree Programs
Clinical research refers to the process by which new drugs, medical devices, and treatment protocols are developed and integrated into the healthcare system. This process is a complex one that typically involves scientific research, clinical trials, peer reviews, and formal approval procedures. The research and development phase often requires the coordination of multi-disciplinary teams that may include laboratory scientists, healthcare clinicians, chemical and biological engineers, computer programmers, data analysts, regulatory affairs specialists, pharmacologists, bioethicists, and medical experts. Once clinical trials are completed, the results must be compiled and presented to industry experts and government regulators according to strict protocols for official approval. Managing this multi-tiered, time-intensive, and expensive process requires training in organizational leadership and communication, a familiarity with various research methodologies, and an understanding of the laws and regulations pertaining to medical research. This is the skill set that defines the field of clinical research administration, or CRA.
What Is a Master’s in Clinical Research Administration Degree?
A master’s degree in CRA is typically a Master of Science degree program that prepares students to manage clinical research and trials that yield new medical devices, biologics, and pharmaceuticals. Students in a CRA program learn about the clinical procedures, regulatory constraints, ethical concerns, and business imperatives that apply to medical research. They study experimental design, clinical trials, and oversight protocols for studies that may involve human and/or animal subjects. And they cultivate the healthcare systems management and technical communication skills needed to align the needs of scientific researchers with those of non-technical administrators and executives at hospitals and medical centers, government agencies, pharmaceutical companies, medical device manufacturers, and other private and public medical research organizations.
Online Master’s in CRA Programs
As an alternative to traditional, campus-based master’s programs that prepare students for careers in clinical research administration, there are online programs that provide the same training and instruction through distance learning technologies. These programs utilize learning management systems (LMSs) to deliver lectures and other course materials to students anywhere with an Internet connection. Students in an online master’s in CRA program receive all or most of their instruction online. They interact with instructors, participate in discussion forums, submit assignments, and can often access library resources and other supplemental materials by logging on to the program’s LMS. Online CRA programs offer what is often a more convenient and flexible pathway to earning an advanced degree in clinical research administration for students who want formal training in this field without having to relocate or commute to a college or university campus.
How OnlineEducation.com Identifies and Classifies Online Master’s in Clinical Research Administration Degree Programs
OnlineEducation.com research online master’s programs, identifies programs that offer training in clinical research administration, and classifies these programs based on several relevant criteria. Programs must be offered by regionally accredited, non-profit colleges and universities. All or most of the required coursework in these programs must be delivered online. Programs that require students to attend more than two campus visits per year are not included on the site. Common designations for master’s in clinical research administration programs include:
- Master of Science in Clinical Research Administration
- Master of Science in Health Sciences in Clinical Research Administration
- Master of Science in Clinical Research Management
- Master of Science in Clinical Research Organization and Management
- Master of Science in Clinical Research and Product Development
What Students Learn in an Online Master’s in Clinical Research Administration Program
While there is not currently a formal accrediting agency for master’s in CRA programs, the Consortium of Academic Programs in Clinical Research (CoAPCR) maintains Core Competency Domains for professional training in the field. As outlined by CoAPCR, training in clinical research administration integrates technical knowledge of research methodologies, regulatory compliance, and medical science with what are referred to as the soft skills of organizational management, leadership, and communication. Online master’s in CRA programs offer a curriculum that addresses topics in the eight competency domains defined by the CoAPCR:
- Scientific Concepts & Principles of Research Design
- Medical Product Development
- Ethical Considerations & Responsible Conduct of Clinical Research
- Clinical Study Operations & Regulatory Compliance
- Study & Site Management
- Data Management & Informatics
- Communication of Scientific Data
- Professionalism, Teamwork, & Leadership
Students in these programs learn principles of epidemiology, biostatistical analytics, and data management. They are introduced to internal review board (IRB) processes common in medical research, FDA oversight and approval procedures, federally mandated provisions for the treatment of animals in clinical research, and relevant aspects of HIPAA data security provisions. And they study management practices in healthcare organizations with a focus on quality control, risk reduction, and regulatory compliance. Finally, many programs challenge students to apply what they have learned in a capstone project related to clinical research administration.
Online Master’s in CRA Courses
The table below offers an overview of courses commonly offered in a master’s in CRA program. The names and descriptions are drawn from actual programs.
|Course Title||Course Description|
|Critical Analysis in Clinical Research||An overview of the scientific, clinical, and regulatory concepts relevant to the development of new medical treatments.|
|The Clinical Research Industry||How clinical research managers integrate project management principles, decision-making models, cross-cultural competencies, and interdisciplinary team dynamics to facilitate clinical trials.|
|Clinical Research Operations||The administrative and operational knowledge necessary to oversee clinical trials, with a focus on budget and contract negotiations, site evaluations, marketing and advertising, and financial audits.|
|Clinical Trials||The regulatory responsibilities of clinical investigators, sponsors, monitors, IRBs, the FDA, and other parties involved in clinical research.|
|Biostatistics for Clinical & Translational Research||The use of biostatistical data in research design, with a focus on populations, sample selection, variables, hypothesis formulation, correlation, and regression analyses.|
|Epidemiology for Clinical & Translational Research||An overview of epidemiological concepts and their application to study design, with a focus on research used to examine disease frequency and cause-effect relationships between risk factors and disease states.|
|Pharmaceutical Safety & Risk Management||An examination of regulatory, legal, and scientific factors in pharmacology research with a focus on risk management and mitigation.|
|Clinical Research Monitoring||Clinical research practice guidelines with a focus on the monitoring function, site selection, source document verification, and regulatory compliance.|
|Medical Device Development & Regulation||An examination of the regulatory framework for the design, development, approval, and marketing of medical devices.|
|Contemporary Topics in Research Management||Leadership issues in research management, with a focus communication, motivation, change theory, organizational culture, problem solving, negotiation, decision-making, and mission and values.|
|Contracting & Budgeting for Industry Sponsored Clinical Trials||An overview of guidelines for professional and ethical practices in contracting, negotiating, and budgeting for industry-sponsored clinical trials.|
Admissions to Online Master’s in Clinical Research Administration Programs
Baseline eligibility for admissions to online master’s in CRA programs is extended to applicants who hold a bachelor’s degree from an accredited college or university. In addition, some programs require applicants to demonstrate that they have completed one or two years of experience in a healthcare or medical field and/or several undergraduate prerequisite courses that cover anatomy, physiology, medical terminology, and/or statistical reasoning. In addition to college transcripts, programs may require applicants to submit GRE test scores, two or more letters of recommendation, and/or a personal goals statement. Selective programs may consider an applicant’s undergraduate GPA as part of the admissions process, and some programs require applicants to have a GPA of 3.0 or higher. It is important to note that admissions criteria vary by program, and that the requirements for applicants who hold an advanced degree are often different from those for applicants who hold a bachelor’s degree.
Online Master’s in Clinical Research Administration Program Formats
There are several variations in how online programs are structured and formatted that potential applicants should be aware of and may want to consider prior to submitting an application. These variations can impact the relative convenience and/or flexibility of an online program. The three areas of primary concern are: the method of online instruction (synchronous vs. asynchronous instruction); enrollment options (part-time vs. full-time enrollment); and whether or not the program requires students to attend campus-based instructional sessions.
Synchronous vs. Asynchronous Instruction: Online courses that utilize synchronous instruction hold lectures and other class activities at regularly scheduled times. Students in these courses must be prepared to log on to the program’s LMS at specified times in order to participate in these instructional sessions. Online courses that utilize asynchronous instruction do include a real-time component. Students in these courses can access lectures and other course materials 24-7. While synchronous instruction provides more structure than asynchronous instruction, it may create scheduling conflicts for some students. Asynchronous instruction poses fewer potential scheduling conflicts, but it requires students to be more vigilant and self-motivated in order to ensure that they complete assignments on time.
Part-Time vs. Full-Time Enrollment: Online master’s in clinical research administration programs are typically designed to accommodate working professionals who may not be able to manage a full-time course load. Many programs provide students with a range of enrollment options, which determine how many courses a student takes per term and how long it will take to complete the program. Enrolling full-time in a master’s in clinical research administration program typically means taking three or four courses per semester and graduating in roughly two years (four traditional semesters). Enrolling part-time allows students to take fewer classes per semester but can extend the time to completion by a year or more. Some programs offer courses year round, which allows full-time students to graduate in less than two years and part-time students to complete their requirements in two years provided they are willing to attend summer sessions.
Campus Visits: Many online master’s in clinical research programs offer all of their coursework online and do not require students to attend campus-based sessions. However, campus visits are an integral component of some online programs, which require students to come to the school’s campus or another location for seminars, workshops, and other instructional activities. These on-campus sessions, often referred to as intensives or immersions, can be a valuable part of the online educational experience, particularly for students who would like an opportunity to meet face-to-face with instructors. But they require travel and students may incur expenses in addition to base tuition and fees while attending campus sessions. Prospective applicants should inquire with programs to determine whether or not there are campus visit requirements. OnlineEducation.com does not include programs that require more than two campus visits per year.