The article below provides detailed information about the advantages of earning a master’s degree in clinical research. It also will describe the different specialties and occupations you can find in this growing profession. We also list some of the best online universities where you can earn your graduate degree.
A career as a clinical research associate (CRA) or manager is an exciting healthcare career that many people want. In 2012, the occupation of clinical research associate was named as a top job according to CNN. But what exactly does a clinical research associate do?
Essentially, a CRA manages clinical trials for a clinical research organization or CRO. A clinical trial is a study that tests if a drug, medical device or biological product is safe and effective. Clinical trials are an essential part of the FDA approval process in the US. So, a CRA monitors trial procedures and results. It is extremely important to follow all correct protocols in the trial, or the principal investigator or health care facility can get in hot water with FDA.
A CRA can work on a virtually endless number of clinical trials, so you can enjoy a very dynamic work environment that changes a great deal from week to week.
The life of a CRA usually is very busy, and you can expect to work up to 60 hours per week. One of the unusual aspects of the CRA occupation is that you need to often travel to various research clinics around the US to monitor the trial. According to some estimates, many CRAs may spend three weeks out of every month on the road.
While this depends upon the organization, you can be sure that you will need to travel a good deal. Most clinical trials have several test sites. You will need to, for example, review the source data for each trial, and make sure that the protocol is being followed.
For instance, FDA requires that informed consent forms for clinical trials be very precise in their language and they all must be signed by the clinical trial participant. A CRA must make sure that these procedures are followed. If informed consent forms are not properly filled out, FDA can sanction the principal investigator. Below are more duties that clinical research professionals engage in on a daily basis:
- Developing trial protocols.
- Presenting the trial protocols to a committee of physicians.
- Designing forms to collect data accurately, which are known as Case Report Forms or CRFs.
- Coordinate with the ethics committee, which has the very important role of guarding the rights and health of all clinical trial subjects
- Identify and assess all clinical trial sites
- Working with doctors and consultants on each clinical trial
- Setting up the clinical trial site. This includes making sure that every site has all necessary trial materials, including consent forms and the drug itself.
- Verify that all of the data that is put onto CRFs is 100% consistent and meets FDA standards.
- Collecting all CRFs from clinical trial sites and submitting them to the correct authority.
- Dealing with FDA clinical trial audits.
- Coach other CRAs about the essential aspects of trial management.
- Coordinate that all clinical trials are smoothly monitored, which involves finding the best and competent staff who are highly trained in all trial procedures.
Many CRAs enter the field with a bachelor’s degree in one of the life sciences, but many clinical trial managers and supervisors eventually earn their master’s degree in clinical research. You will find the best paying opportunities in this field come to those with a master’s degree.
New drugs and medical products are constantly in development, so you will never have a lack of work in the CRA field. Walden University states that employment growth in this field will continue to expand rapidly as there is more clinical research being done in many areas of medicine. This makes sense because people are living longer and want to live as productive lives as possible. This means that they want better drugs and medical devices available, which requires clinical research.
After you graduate from your clinical research degree program, you may want to consider earning your ACRP (Association of Clinical Research Professionals) certification. This certification will tell employers that you have all of the skills needed to run a clinical trial properly.
This is incredibly important; clinical trials involve human lives. If a trial is not run according to FDA regulations and the stated protocol, the trial can be shut down.
Earn Your Degree Online in Clinical Research
If this sounds like a career in which you may be interested, review some of these high quality clinical research degree programs below. If you do not have a science based bachelor’s degree, you will likely need to complete several prerequisites to qualify:
#1 Drexel University – Master of Science in Clinical Research Organization and Management
Drexel University features an online MS in clinical research that has 12 courses and is offered by the school’s College of Medicine. It is specifically made for an experienced research professional that wants to hone her clinical management skills.
This program will provide you with a highly advanced set of skills that you can use to manage clinical investigations for pharmaceutical, biomedical, medical device and diagnostic companies.
The program is led by highly distinguished researchers, administrators and scientists who have decades of experience in clinical trials around the world. It also features a comprehensive curriculum in these areas:
- New product research
- Regulatory compliance
- Biostatistics and management of trial data
- Clinical research safety
- New product development
There is no residency or thesis requirement with this three year program. Your courses include:
- Pharmaceutical R&D
- World Wide Regulation Submissions
- Introduction to Clinical Trials
- Innovative Product Development
- Biotechnology and Research
- Ethical Issues in Research
- History of Misconduct in Research
- Compliance Issues
- Designing Clinical Trials
- Health Policy and Economics
- Quality Assurance Audits
- Fundamentals of Compliance
#2 Walden University – Master of Science in Clinical Research Administration
Walden University offers this online master’s program that will get you up to speed on clinical research administration. You will be ready to tackle key roles to manage and monitor clinical trial phases and processes. This online program looks in depth at the latest technology and the best and safest ways to do tests, how to protect human subjects, and more.
You will study classes in product development; business of clinical research; epidemiology and good clinical practices (GCP). The coursework is intended to provide you with a broad perspective of the processes that produce the best clinical research trials.
You can expect to take these specific classes:
- Design and Conduct of the Clinical Protocol
- Regulatory Considerations in Clinical Investigations
- Clinical Research Introduction
- Information and Data Management
- Health Economics
- Product Development in the Drug and Device Industries
Some of the job roles you can expect to enjoy after graduating from this two year program include:
- Clinical data manager
- Subject recruiter
- Principal investigator
- Drug safety officer
- Site manager
- Clinical research coordinator
- Clinical research associate
Earning a master’s degree in clinical research will provide you with an excellent salary and a lot of work. You also will probably need to travel a good deal. And you also have the opportunity to help to improve and save lives by providing the world with better medical products and medicines.