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This activity is supported by the US Food and Drug Administration (FDA) through a contract from the Department of Health and Human Services, and FDA's privacy policies apply while you are on this site. Continuing Education Credits (CE) Released: 2/25/2016; Valid for credit through: 2/24/2019
Credits Available:
Physicians – 1.5 AMA PRA Category 1 Credit(s)™ Nurses – 1.5 ANCC Contact Hours Pharmacists – 1.5 ACPE Contact Hours Nurse Practitioners – 1.5 AANP Contact Hours Physician Assistants – 1.5 hours of Category I Credit
Certificates of Completion:
For users wishing to have confirmation that they have completed this course, they may choose to receive a Certificate of Completion which comes with no CE credits.
Target Audience:
The target audience for this course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists. The course can be taken for informational purposes or for Continuing Education (CE) credit.
Description:
This activity explains how U.S. public health policy has influenced and shaped the Food and Drug Administration (FDA) protections that Americans have come to expect, provides an overview of FDA’s Center for Drug Evaluation and Research, or CDER’s, role in the regulation of new drug development, marketed drugs, quality testing, and post-market surveillance, and identifies new directions for the human drug regulatory process in the United States.
Free FDA Online Program about FDA's Role in Public Health
Learning Objectives:
Upon completion of this activity, participants should be able to:
Describe and explain the drug development and review process in the United States for new drugs, generics, over-the-counter (OTC) drugs, and biosimilars
Outline CDER’s role in post-marketing safety surveillance for medical products
Identify ways CDER disseminates safety information about medical products to both health care professionals and their
Describe CDER initiatives and commitments for the protection of public health
Describe the new drug development and review process
How to Get a Clinical Research Associate (CRA) Entry Level 1 Job Article
There is a huge demand for Clinical Research Associates (CRAs) with two years experience so much so that there are dozens of recruiters in the field who are paid thousands of dollars for placing people in a job. Also, experienced CRAs can get sign-on bonuses too as part of their new job offer. Step one for getting experience is getting an entry level Clinical Research Associate (CRA) Level 1 job; however, if you have no industry experience, it will seem impossible to get one. It does seem a paradox, how can you have CRA experience to get a CRA job? If you are unsure what a CRA does then read this blog post to learn more about the job responsibilities.
I have met many people who want to become a CRA. I have also talked to many people who are CRAs. From this I have found there is no one way that someone becomes a CRA. There are steps you can take to help make sure your job application stands out. Overall, most all companies require a bachelor's degree preferably in science. However, I have seen a few people with only a 2-year college degree but who have industry experience get CRA jobs. It is getting harder though to get a CRA job without a 4-year college degree.
First thing is to learn the language of the clinical research industry. There are a lot of acronyms and it is important to understand the different groups working in the industry. If you can know a few key terms and concepts at the time of the interview, it will show that you have genuine interest in the field and an understanding of what is involved.
How to Get a Clinical Research Associate Level 1 Job Article
It is often easier to get into an entry level Clinical Research Associate job once you have a job already somewhere in the clinical research field. This often means getting an in-house position at some company like a CRO or Sponsor and then transferring into a CRA 1 job once it becomes available. Many companies will hire internally as part of job promotion opportunities. Also as an internal employee, you can also an employee, you can request to accompany CRAs on their work trips to observe and learn. Often there are data deadlines and a CRA will need an extra set of hands from someone who understands the study. This gives you the opportunity to prove yourself as a valuable and qualified job candidate prior to getting the CRA 1 job. Internal jobs can be a Clinical Trial Assistant (CTA) / Clinical Research Assistant (CRA) or an Administrative Assistant (AA). Most people go from CTA to CRA 1 went they want to transition. I do know one person who worked 6 months as an AA before she became a CRA. To do these jobs requires living near a Sponsor or CRO office so you can work in-house. Unfortunately, the industry tends to be clustered in a few key areas in the United States but search to find what is near you.
Another path to becoming a CRA is to be a Study Coordinator (SC) / Clinical Research Coordinator (CRC). (Read this blog post about getting this job.) On and off over the years, different Sponsor/ CROs have hired CRCs as entry level CRAs. The benefits of this route is you don't necessarily have to be near a Sponsor or CRO office. Qualified CRCs understand the clinical research process, but they have not learned the Sponsor/ CRO side of study management. A Sponsor/ CRO will bring the CRCs in-house for approximately 2 weeks of on site job training on how to be a CRA. After that time, the new CRA goes back to wherever they were located and works regionally from home. The main demand for CRC to CRA positions is in the field of oncology given that it is an in demand therapeutic area but there have been CRC to CRA opportunities in all therapeutic areas. A benefit of being a CRC is that you will get to meet CRAs as part of your job. If you become friends with the CRAs and are applying to their company then the CRA can be a referral for you too!
For both routes, you'll need to subject your job application to a Sponsor or CRO. The big CROs (Quintiles, Covance, PRA, PPD, Parexel, Inventiv, INC Research, etc.) use an online application form. I have talked with the corporate recruiters over the years at the various companies to ask them about their CRA 1 application process. Most advise applying online and putting in a job search for the CRA 1 position. The recruiters advise submitting an updated resume every 6 months.
If you are looking to get into the clinical research field/ career, a "clinical research coordinator" (CRC) or "study coordinator" (SC) job can be one of the easiest ways to get your first clinical research job. If you search on "study coordinator" or "clinical research coordinator" you will find many different qualifying job descriptions and pay ranges. That is because there are many different CRC/SC needs depending on who is hiring for the clinical research job.
In general I have seen a variety of study coordinators with different backgrounds over the years. Some have entry level skills such as only a high school diploma or maybe they were a medical assistant. For CRCs at this level, the pay is often hourly and low. Often it is a large clinical research center that hires these CRCs or it is a private medical office that got into clinical research and had their office medical assistant also take on the role of becoming a study coordinator.
More often, CRCs have a college level degree. This could be a bachelors degree or a nursing degree. Nurses are often paid more just because they are trained to do more procedures. Sometimes, CRCs have advanced degrees but they are often in a management role too.
Getting a CRC job is often a paradox, To get a job you need experience, but the main way to have experience is to get a job. Very few places will hire you with no experience and train you. If they do train you often the job offers a lower hourly wage even with a college education.
One way to distinguish yourself is to learn how to speak the "language" of clinical research. If you can know a few key terms and concepts at the time of the interview, it will show that you have genuine interest in the field and an understanding of what is involved.
All this will make you sound like more of a research industry insider so the terms like ICH, GCP, CRF, EDC, ICF, 21CFR, CRO, etc. don't intimidate you and will make you a more qualified Clinical Research Coordinator/ Study Coordinator candidate who gets the job!
A CRA supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of pharmaceuticals, biologics, or devices, may employ these individuals either directly or indirectly via contract research organizations (CROs), or as independent consultants or contractors.
Here is a summary and explanation of a Clinical Research Associate job description for someone not in the industry.
A CRA is also called a "Monitor" as an alternate job name because of their main job role of "monitoring" clinical trials. (Click here to read the blog post explaining what a clinical trial means.) A clinical trial or "study" is a scientific way a new drug, biologic, or device is tested in humans so as to get regulatory approval to sell and use in a particular country.
A CRA is either employed by a Contract Research Organization (CRO) or sponsor. (Click here to read the blog post explaining who works on a clinical trial.) A Sponsor owns the new drug, biologic, or device being tested. However, a sponsor may "contract" out managing their clinical trial to a CRO.
A CRA can be an employee or an independent contractor. A contract CRA is actually a "CRO" company of that one CRA.
A CRA is assigned the management of sites where the study is being performed. The CRA will be the main point of contact for the site about the study. The CRA will occasionally travel to the site to "monitor" it.
During a site visit, the CRA will have different tasks to accomplish depending on the status of the clinical trial. The CRA is generally meeting with the Principal Investigator and Clinical Research Coordinator during the visit. There are four main types of visits: 1. Site Qualification Visit (SQV) / Pre-qualification Site Visit (PSV): A CRA will visit potential sites being considered for the study to determine if the staff and facilities are adequate. 2. Site Initiation Visit (SIV): The CRA will train site staff on the protocol, review regulatory documents, and ensure all study materials are on site so the site can open the clinical trial to start screening and enrolling subjects. 3. Interim Monitoring Visit (IMV): The CRA will review the subject's source documents and reconcile them with Case Report Forms (CRFs), study materials on site, and regulatory documents. 4. Close-Out Visit (COV): This is the final study visit. Study materials are returned if this was not done during an IMV. A final review and reconciliation is done on the subject source files and regulatory documents to make sure they are complete.
When a CRA is not traveling, the are "in house". This can be at a work office or home office. During this time the CRA may perform these job duties: 1. Write "monitoring reports" which document what happened during a site visit. 2. Email and call sites to discuss study updates and pending issues. 3. Communicate updates to other study team members and reviewing clinical trial data. This can be updating trackers, a clinical trial management system (CTMS), or other systems.
A CRA receives therapeutic and protocol training before they start the clinical trial. This happens for each trial.
Before a CRA starts working for a particular company, they receive training on "Standard Operating Procedures" (SOPs). These are guidelines that a Sponsor or CRO put in writing to state how everyone should perform various tasks on a clinical trial.
This is not a complete list of what a CRA does but a general description. There is also another CRA role called the "Lead CRA" which has more of a clinical trial management focus. That position will be discussed in more detail a later post.
ACRP defines the CRC role as:
"A CRC works at a clinical research site, with study subjects, under the immediate direction of a principal investigator, whose research activities are conducted under GCP guidelines."
But what does this job description mean?
A clinical research site is a place where is "clinical trial" is conducted. (If you are unsure what a clinical trial is then read this blog post.) A Sponsor (drug, device, biotech) of a trial will find medical clinics to offer an "Investigational Product" (IP). A clinic will enroll patients into a clinical trial. Once a patient decides to participate in a trial then the person is referred to as a study "subject". There is at least one physician (or someone of appropriate training) who will oversee the trial at the trial at the clinic called the "Principal Investigator" (PI). (To learn more about study roles, read this blog post.) The PI will provide guidance to the CRC, but the CRC mainly works independently to manage the clinical trial at the site. The word "GCP" refers to "Good Clinical Practice". It is a set a guidelines (country specific) on how a clinical trial should be conducted.
Some of the responsibilities of a CRC with patients/ study subjects include:
Performing a chart review on clinic patients to see if any potentially qualify for the study. If they do then call the patient to see if they want to come in for the study.
If the PI has a patient in the office for a clinic visit who is interested in the study then the CRC will help explain the study and required office visits/ procedures to the potential subject.
If the site is advertising the study, then the CRC may discuss the study with people who are not regular patients of the clinic but want to participate in the study.
If a patient is interested in enrolling in the study, the the CRC will review a document called the "Informed Consent Form" (ICF). This document explains in writing the study procedures, risks, safety information, and rights of a study subject.
Once a patient becomes study subject, the CRC will coordinate the office visits, as well as, follow-up contacts between visits. The CRC is often the main person that works with the study subject during the clinical trial.
At office visits, the CRC will ask a subject about past medical history, take vital signs, draw labs samples (if needed), administer questionnaires, and give instructions to the subject on how to comply with the study protocol requirements. The CRC will ensure the PI meets with the subject as needed and updates the PI on the subject's health and status.
Between office visits, the CRC will contact the subject to give reminders about study visits, ask about the subject's health, and answer study questions.
The CRC records all their subject interactions in records called "source documents". A source document is considered the first place a piece of data is written and could be a piece of paper, an x-ray, or captured directly in an electronic medical record (EMR).
The CRC will take the source document data and transfer it to a "Case Report Form" (CRF). This is a data form that will transmit the study data (questionnaire answers, vital signs, physical exam results) to the Sponsor. The reason it needs the study data needs to be entered into a CRF is so that it removes "personal health information" (PHI) that would allow a subject's identity (name, address, local medical records numbers) to become known to the sponsor.
A CRC also works with Sponsor or Contract Research Organization (CRO) staff. Here are some of those responsibilities:
The Sponsor/ CRO matching role can be considered to be the "Clinical Research Associate" (CRA) which is also called the "Monitor". The CRA acts a study liaison with the site providing study updates. The CRA will occasionally visit the site for training or to review data. Between office visits, the CRA will contact the CRC to provide study information and ask certain study tasks be completed.
The CRA will compare the source documentation to the CRF during the visits. If the source data conflicts or is missing in the CRF, then the CRA asks the CRC to resolve or clarify the issue. CRAs are not allowed to change data. They can only review it. The CRA will give the CRC a "data clarification form" (DCF) also known as a "query".
Once the CRF data is transmitted to the Sponsor or CRO, many other staff will look at it and may also issue DCFs too.
The CRC works with an independent Ethics Committee (EC) or Institutional Review Board (IRB). (IRB is the term used in the United States and EC is used by the rest of the world.) The EC/IRB is a group (per local country guidelines) that oversees the trial. Responsibilities of reporting to the EC/IRB include:
Completing the initial application and obtaining approval to have open the clinical trial at the site.
Answering questions that the EC/IRB may have about the study.
Providing updates to the EC/IRB on the study's progress including safety updates and any significant site errors or problems with the study.
Notifying the EC/IRB once the study is complete.
There are additional responsibilities than those noted above, but this is a general guideline. The PI is also overseeing and is responsible for the CRC's work throughout the trial. Larger clinics break up the CRC's responsibilities such as having one staff focus on recruitment, one person for processing and shipping lab samples, and another for handling all EC/IRB communications and regulatory documents.
Clinical trials play a pivotal role in evidence-based medicine. This course will discuss the design, conduct, analysis, and interpretation of Phase I-IV clinical studies.
What you'll learn
Fundamentals of Clinical Trials Free Harvard X Course
The scientific, statistical, and ethical aspects of clinical trials research
How to design, implement, and analyze data from clinical trials
How to interpret results from clinical trials
The ethical issues that arise at each phase of therapy development
Who Works on a Clinical Research Studies or Trials?
The Sponsor overall is responsible for the trial conduct; however, the Sponsor outsource work to another company called a "Contract Research Organization" or CRO. The Sponsor and CRO work together in overseeing the study. There may be one or multiple CROs involved in a clinical trial. The Sponsor or CRO will find different doctors called "Investigators" in many different locations who agree to follow the protocol and will administer the Investigational Product at their clinic. The lead doctor is called the "Principal Investigator" and manages oversight of the study at the clinic. There may be additional staff (doctor, physician assistant, nurse practitioner) who are responsible for performing key study assessments and they are called "Sub-Investigators". The Investigator is assisted by a "Study Coordinator" (SC) or "Clinical Research Coordinator" (CRC) at the medical clinic who helps the doctor to manage the administration of the study. A CRC can be a nurse, medical assistant, or other clinic staff. A position that links the Investigator's sites to the Sponsor/ CRO is called a "Clinical Research Associate" or CRA. The CRA works on behalf of the Sponsor or CRO to oversee the site. This means reviewing all the study documents (medical records, trial data, study correspondence) to ensure that the clinical trial is being conducted according to the protocol and regulatory requirements. If CRA provides training and feedback to the site staff to ensure to help them keep compliant. Overall the Investigator is responsible for all work done at the site but the CRA works in collaboration with the site to make sure quality research is being performed. The CRA travels to the different clinics to perform this review and mainly works with the CRC during these "monitoring visits". Clinical research seeks to find cures for cancer, diabetes, genetic diseases, and more. Clinical research professionals work as a team to innovate these medical breakthroughs. This was a general overview of only some of the jobs that manage a clinical research trial or study. A career in this field means learning how to protect the safety and well being of humans who participate in these trials while looking for the next generation of medical healthcare treatments. The above information was tested for clarity in conversations with taxi cab drivers on trips to and from airports. - Article by Laurel Latto, Certified Clinical Research Associate (CCRA)
