CLINICAL RESEARCH FASTRACK: GETTING STARTED...CRAs typically have 2-5 years of relevant industry...

Average Clinical Research Coordinator annual pay is $59,955*. Careers in this industry have six figure income growth potential.*Salary.com

CLINICAL RESEARCH FASTRACK: GETTING STARTED

A Career in Clinical ResearchRewarding Careers High DemandGreat PayIs this right for me?

800-610-3171 • [email protected]


The Clinical Research Industry!Clinical research is a vibrant and growing sector of healthcare. It is currently estimated to amount to over $150 billion in spending in the United States alone. This field is conducting FDA clinical trials for the biotechnology, pharmaceutical, medical device and other related healthcare industries.

In 2017 more drugs were approved by the Food and Drug Administration than in any of the previous years on record. Each week over 200 new clinical trials are registered into the national database (clinicaltrials.gov) and the industry is projected to continue to grow at a rapid pace without signs of slowing. Advances in science, computer technology and healthcare are propelling this field into a bright future, and creating a large number of new job opportunities. At the beginning of 2018 over 50,000 clinical research jobs were available across the country and the demand for qualified and trained clinical researchers is putting upward pressure on salaries within industry.

Clinical Research DefinedClinical research is a sector of healthcare science that determines the safety and efficacy (effectiveness) of medications, devices, diagnostic products and treatment regimens intended for human use. Simply put, what distinguishes clinical research from all other forms of research, is that this field conducts research on therapies in humans.

What are clinical trials?Clinical trials are studies that are performed to make sure that pharmaceutical drugs, medical devices and other treatments are safe and effective. Before a drug can be prescribed to the public by a healthcare provider, it must be deemed beneficial and safe and approved by the FDA. Clinical trials are performed both globally and in the United States.In the U.S., this industry is carefully regulated by the FDA. Clinical trials are conducted at hospitals, doctors’ offices or stand-alone research sites.

What is a CRC? - Clinical Research Coordinator?Clinical Research Coordinators (CRCs) conduct clinical trials on research participants at designated research sites. Clinical research coordinators are responsible for ensuring the trials are conducted using internationally accepted good clinical practice (GCP) guidelines, and that the protocol of the study is precisely followed. Clinical Research Coordinators also help to ensure the trial is performed in an ethical manner, and the rights and safety of the patient are protected. Coordinators work closely with doctors, study participants, clinical staff, and play a vital role in the testing of new drugs, devices and other treatments.

Today’s clinical

research is

tomorrow’s

medical practice. Nancy Lizzul, Director of

Clinical Research, The Mayo Clinic, Instructor at Clinical

Research Fastrack

The future depends

on what you

do today. —Mahatma Ghandi



Go where you

are celebrated—

not tolerated. If

they can’t see the

real value of you,

it’s time for a

new start. —Unknown

What is a CRA? – Clinical Research AssociateClinical Research Associates work for Contract Research Organizations (CROs), or the sponsors of clinical trials (pharmaceutical companies, biotech companies, medical device companies, etc.) to support the delivery of a clinical trial. CRAs travel from site to site in order to monitor the quality and progress of the study and ensure the data is being collected correctly, according to international guidelines, FDA regulations, and the protocol of the trial. CRAs typically have 2-5 years of relevant industry experience and often start out as Clinical Research Coordinators.

In 2016 Forbes Magazine rated the CRA the #1 high paying flexible job of the year! CNN Money Magazine has rated the role of CRA as one of the top 20 jobs in the country several times over the past couple decades.

What is a PI? - Principal Investigator Every site needs an investigator, typically an individual with an advanced degree (MD, DO, PhD, PA, NP) to oversee the trial. They delegate responsibilities of the trial to other study staff, including research assistant, clinical research coordinators, sub-investigators, and others. Their job is to ensure that the study participants receive adequate oversight and care during the trial. It is also a great way to offer patients an alternative to standard of care treatments that may not be effective while generating revenue for an existing practice or hospital system. Many Principal Investigators supplement their clinical practice with clinical research while others choose to focus their efforts solely on their research practice.

What are other common roles in the clinical research industry?Once an individual enters into the clinical research industry, a world of opportunities opens up. For career-minded professionals, the research sites and (CROs) that conduct trials have a wide range of research related positions available, such as: data managers, research assistants, regulatory affairs coordinators, project managers, site supervisors, coordinators, associates, senior clinical research coordinators, and senior clinical research associates. After a professional is trained and qualified to enter the industry, the opportunities for growth and advancement are impressive and unparalleled in most other sectors of our economy.



HOW TO BREAK INTO CLINICAL RESEARCHWhat educational background do I need to work in clinical research?While no specific degree is required to enter the field, the clinical research field highly values education. To become a research assistant or clinical research coordinator it is recommended that a candidate have an interest in learning, a passion to work in healthcare, and at least an Associate’s degree, and preferably a Bachelor’s degree.

Clinical Research Fastrack offers a Clinical Research Professional Bootcamp Training course which requires students to have at least 60 college credits, LVN/LPN or a medical assistant license. While this industry allows for both lateral and vertical growth for motivated and hardworking individuals, many senior positions like that of a CRA or a Project Manager prefer to hire those with an advanced degree.

Clinical Research Fastrack also offer a Clinical Research Principal Investigator course for those qualified to oversee the running of clinical trials at a site. To be a Principal Investigator, a candidate must have the proper qualifications to oversee that the rights and safety of the study subjects is protected and that the site is following the protocol as well as FDA regulations and Good Clinical Practice guidelines. Most PIs hold advanced degrees including MD, DO, PhD, PA, and NP.

What types of trials or studies do clinical researchers work on?Clinical trials are performed to find treatments and therapies for a wide variety of conditions, ranging from the flu, to Alzheimer’s disease, to heart disease, and cancer. Some clinical researchers focus on specific therapeutic areas such as diabetes, while others work in settings where they may work on a wide range of disease treatments.

What are the day-to-day duties of a clinical research coordinator?Clinical Research Coordinators work closely with the research team to ensure the study is followed properly, and that patients receive the proper care. Coordinators work under “principal investigators” (the physician in charge) to screen patients, enroll them in the study, be an advocate for the patient’s care, and collaborate with the healthcare team at the site.

A CRC has knowledge of the FDA rules and regulations, as well as the international guidelines of ICH GCP, to ensure that the safety of the patient is protected, and credible data is collected throughout the trial. By the end of a trial, the CRC will help submit findings to the sponsoring organization for reviewal.

Why are there so many great paying jobs in clinical research?Clinical research is a growing and thriving industry yet very few people know about this career opportunity. Young people (and even mid-career professionals looking to transition into a new sector of healthcare) are applying to nursing programs and other healthcare disciplines. While industries such as software development and engineering remain popular, very few people know about a career path in clinical research. As a result, the demand for CRCs and CRAs is high, and the supply is low. Therefore, CRCs with as little as two years’ experience are annually making $59,955 per year, according to salary.com.

If you’re offered

a seat on a rocket

ship, don’t ask

what seat! Just

get on. —Sheryl Sandberg

Take the risk to

invest in yourself

and follow your

passion and you will

wake up energized,

every day. David Silberman, CEO,

Clinical Research Fastrack



Opportunities

don’t happen,

you create them. —Chris Grossner

With additional experience, a coordinator could apply to work at a CRO, pharmaceutical company, or medical device manufacturer to serve as a CRA and potentially earn up to $90,000+ annually. As a professional develops more competency in the industry, opportunities arise to become managers at research centers and sponsoring agencies, where salaries frequently reach six figures.

Why become a clinical researcher now?Due to the growth and size of the industry and the recent passing of the 21st Century Cures Act in 2016 in the U.S., the demand for qualified and trained clinical researchers has never been greater. The pace of the industry is accelerating and talented professionals are in high demand.

The biotech industry is showing great promise, and as a result the clinical research industry is projecting to be a flourishing opportunity in the years to come. No time in our history has this type of investment in clinical research taken place, and now is an optimal time to take advantage of the existing demand.

How does the pay of a Clinical Research Coordinator compare to other healthcare careers?CRCs are being paid better salaries than many other healthcare careers that require similar levels of education. After two years in that role, a CRC earns on average $59,955, which is $15,000 more than a typical Licensed Vocational Nurse, $27,000 more than a medical assistant, and $27,000 more than the average pay of a phlebotomist. After a couple years on the job, CRAs are often making over $90,000 per year.

Healthcare Career SalariesMean annual salaries*

JOB TITLE MEDIAN ANNUAL SALARY TRAINING REQUIRED

Clinical Research Coordinator $59,955** Postsecondary non-degree award recommended. Programs range from 6 weeks to 2 years in length.

Clinical Research Associate II $65,000** Bachelor’s degree in Science or equivalent, 2 or more years’ experience in the field.

Dental Assistant $37,630* Post Secondary non-degree award

LPN / LVN (Licensed Vocational Nurse) $45,030* Post Secondary non-degree award

Medical Assistant $32,480* Minimum of one year from an approved program

Medical Records and Health Information Technicians $39,180* Post Secondary non-degree award

Opticians (Dispensing) $36,250* High School Diploma or equivalent

Pharmacy Technicians $31,750* High School Diploma or equivalent

Phlebotomist $33,670* Post Secondary non-degree award

Physical Therapist Assistant $49,920* Associate Degree*Data is from the Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, 2017 Edition, Healthcare Occupations, on the Internet at http://www.bls.gov/ooh/healthcare/home.htm (visited April 15, 2018).

**Data is from www.salary.com

This represents a median based on national data. The particular salary of an individual may be more or less depending on the training and experience of the candidate, the location of the position and the pay scale of the specific employer.



How is Clinical Research Fastrack making the difference?Clinical research is a heavily regulated and monitored field. Professionals within the industry often do not have the necessary time to allocate for on-the-job training for new hires. As a result, the industry relies on hiring professionals with prior experience.

As a growing industry, the demand for new talent is high, but most other college or university programs are not providing the industry related experience required to be successful when entering the field. Clinical Research Fastrack offers students the training, externship experience, networking, and connections to help our graduates embark on exciting new careers.

What are the qualities that make a strong clinical researcher?The best CRCs are bright, motivated individuals who enjoy working with people, caring for patients, and managing information. They need to be conscientious and ensure patients are treated properly and must have great attention to detail to ensure the study protocols are followed correctly.

Clinical researchers must be able to communicate well with others, and be open to collaborating with a large team. People who are organized and extraverted tend to thrive in the patient facing side of the industry.

What is the best way to get started?The best way to find out if this career path is right for you, is to discuss the opportunity with one of our representatives. For those who are interested in this career path, Clinical Research Fastrack offers a bootcamp training program to help individuals enter this exciting field quickly.

Short 8 Day Class Structure – Masters level curriculum taught by instructors who are expert professionals currently working in the clinical research field.

Blended Online Learning - We integrate online training into the course to allow our students to learn material from anywhere.

Comprehensive Curriculum – The course covers the critical research concepts and skills needed to be considered for a position in clinical research.

Hands on Clinical Externship – We provide externship opportunities at local research institutions, including the world’s largest integrated trial site network, and at more than 75 medical clinical research sites around the country.

Individualized Career Mentoring, Strategies and Assistance – All students meet with 10-12 industry professionals, a leading pharma recruiter and executives in the industry to network with key decision makers to help them launch their careers.

Clinical Research Fastrack provides financing and scholarships to qualified students. The career opportunities abound in this field and clinical research is changing our world for the better. Contact our admissions department to learn more at 800-610-3171 or at [email protected]!

CLINICAL RESEARCH IS CHANGING OUR WORLD!We are finding the cures to cancer, heart disease, diabetes, stroke, Alzheimer’s and other diseases that effect us all.

JOIN US!Clinical Research Fastrack [email protected] 800-610-3171

CLINICAL RESEARCH FASTRACK: GETTING STARTED...CRAs typically have 2-5 years of relevant industry...

Documents

Transcript of CLINICAL RESEARCH FASTRACK: GETTING STARTED...CRAs typically have 2-5 years of relevant industry...