If you have been researching different careers within clinical research, you might have noticed that there are many different options.
It can be overwhelming at first as you try to figure out which career you might enjoy more, or which jobs to even search for!
I have been in your position before and after obtaining an entry level job in clinical research, I was able to explore different options and obtain a career that I truly enjoy.
Clinical research is a field that is filled with different positions and the best part of all is that you can climb up the ladder and obtain a position that pays well and is very rewarding.
Many of the careers within clinical research allow you to enter the field without experience and many times without having attended college. Even though experience and education is highly valuable in any field, in clinical research you can be trained on the job for entry level positions.
In this article we will go over clinical research jobs that you can obtain within a clinical research site. Even though there are many other jobs within the field, we will keep it simple and take you through the positions that are the most common when working at a clinical research site.
Clinical Research Assistant or Clinical Research Technician
Depending on the clinical research site that you work for, clinical research assistants can have varying roles. When I started out in clinical research, I was a clinical research technician for a phase 1 clinic. This role was a perfect fit for me since I had experience as an EMT working as a technician at an emergency room. At the clinical research site, I was expected to assist the coordinators, doctors, nurses and other staff members. I had previous training when it came to EKG’s, drawing blood, taking vitals and collecting specimens. However, the site which I worked for was willing to train and to help the technicians obtain certifications.
If you have any experience as an Emergency Medical Technician (EMT), or a Medical Assistant (MA), this will be a perfect entry level job in clinical research. You would have all of the technical skills down and will be able to focus on the clinical research aspect of the job. If you don’t have experience, then if you understand the different responsibilities and you are willing to perform them, you don’t always need to have been previously trained.
Once you are in the role you can expect to have subjects assigned to you. You will be responsible for following the schedule of events in the protocol and performing blood draws, ekg’s, collecting urine samples, taking vitals and other procedures as required.
The job of clinical research assistant or clinical research technician can catapult you into the next step which is usually a clinical research coordinator.
Clinical Research Coordinator
As a clinical research coordinator, you will have the responsibility of managing the study at your clinical research site. A clinical research coordinator can also be called a clinical research manager depending on the site.
Depending on the clinical site your work for the roles can vary. Some clinical research coordinators have to do technician duties, regulatory work and even recruitment. However the main role of a clinical research coordinator is to make sure that the clinical research studies are carried out according to protocol. You will have the responsibility of ensuring that the data collected and the procedures performed are completed per the study protocol.
Although the workload depends on the site and how much business they are able to acquire, it is fair to assume you will have to coordinate anywhere from 5 to 10 different trials. The job of clinical research coordinator has a learning curb and can seem a bit overwhelming at the start. However, this makes it all the more rewarding! Plus with experience and the right training, you will start to gain confidence in your new role.
Clinical Research Associate
As you progress through your clinical research career, you can branch off into many more career opportunities. You can become a clinical research associate (CRA) aka site monitor or even a remote site monitor. This position oversees multiple clinical research sites and are usually employed directly by pharmaceutical companies. They visit the clinical sites that are carrying out their research studies to ensure compliance and quality.
Clinical research associates usually have to travel to visit the clinical sites assigned to them. This can include local, national or even international travel. More recently however, after the COVID 19 pandemic more monitor positions have become remote. Companies are realizing that monitoring visits can be performed remotely saving them money on flights and hotels. What this means for you is that you can either apply to a remote or a travel CRA job depending on your lifestyle and preference.
Research is all about data, as a coordinator you are recording this information such as vital signs, subject demographics, medical history etc. As a monitor you are ensuring that this information is recorded as accurately and as standardized as possible. During monitor visits the clinical research associate or monitor will review all of the subject’s charts and ask the coordinator for clarifications or corrections to any mistakes and discrepancies.
Being a clinical research associate usually requires a few years of experience in clinical research. They are basically overseeing clinical research coordinators and with this comes more responsibility. Clinical research associates report back to their team within the pharmaceutical companies. They make sure that as a team they are assisting the clinical research site and the clinical research coordinator in managing the trial.
Clinical Research Site Manager
Clinical research sites, just like any other clinic or healthcare organization, need strong management. A clinical research site manager is responsible for overseeing and supervising the day to day activities that are carried out.
Their background is usually in healthcare and they have progressed up the career ladder into a leadership position. It is helpful if you have an advanced degree such as being a nurse, nurse practitioner, or physician assistant. However, it is not a requirement as you can work your way up within the clinic to achieve this goal. If you have strong leadership skills, or transferable skills from a different field that will definitely be helpful.
As a clinical research site manager you will be overseeing coordinators, primary investigators, nurses and other staff members. Your primary role will be to ensure that the clinic is running smoothly, that everything your team needs is readily available, and that subjects are being seen as efficiently as possible.
You might also be involved in the hiring process, as well as other human resource duties. And you will be included in sponsor/client meetings in order to have an understanding of budgets, contracts etc.
If you have strong leadership skills, or transferable skills from a different field you might find that being a clinical research site manager is an enjoyable career option!
Clinical Research Primary Investigator/ Clinical Research Sub-Investigator
As a primary investigator (PI) in a clinical research site, you are the person who is ultimately responsible for everyone and everything in the study. This is of course an oversimplified way to look at it. The PI is usually a medical doctor, psychiatrist, nurse practitioner or physician assistant. It is most common that a doctor is the primary investigator and the sub-investigator can be a nurse practitioner (NP) or physician assistant (PA).
The PI is responsible mainly for patient safety but also ensuring that all of the staff on the study are properly trained and delegated. That the medication or investigational drug is stored, handled and dispensed correctly and that the data collected is accurate.
Being a PI is a huge responsibility as so much of the clinical research study depends on having a reliable physician who is familiar with the indication being studied.
Support Roles
For the most part even though the following roles still play a very important part in the everyday operations of a clinical research clinic, I would consider them supporting roles. This is because they are not directly subject facing, rather they work in the background to ensure the data is submitted and most importantly it is accurate. As well as ensuring that the clinic is running smoothly by assisting with administrative tasks.
Electronic data management (EDC)
All of the data or information that is collected during the study must be entered into an electronic data management system. Once the patient-facing staff have collected the visit data such as vitals, EKG, bloodwork, adverse events and even changes in medications, the information must be entered into a system that can be monitored.
The sites have a responsibility to the sponsor (the company paying for the study) to submit accurate information into their computer system once the visits are complete. This must happen in a timely and meticulous manner.
If you enjoy inputting data and are comfortable with learning new systems, this might be the perfect clinical research career for you!
Quality Assurance
Quality Assurance or QA can be its separate rule or it can be designated to a seasoned staff member. This position is usually in charge of ensuring that the data being collected and submitted by EDC is accurate.
They are a second set of eyes in order to double check everyone’s work and make corrections as needed. Some of the corrections might involve writing a protocol deviation if there was an error in the way the visit was run or addressing an issue that has been identified as a pattern. They can then retrain staff members in order to prevent the same or similar issues from occurring in the future.
QA can prevent the site from making mistakes and be better prepared in the case of audits.
Administrative assistant
As an administrative assistant, you will be able to assist and work closely with the study staff in order to ensure that the clinic runs smoothly. You might sit at the front desk, check subjects in as they come in for their visits, answer phones and help with scheduling/rescheduling. The tasks can vary greatly but overall this is a great position to get your feet in the door and how a clinical research site is run and about all of the different routes you can take.
Takeways
To recap, these are just some of the jobs within clinical research and as a way to keep it simple we focused on the jobs at the site level. There are many more positions to explore within a Clinical Research Organization or (CRO). We briefly touched on the career of clinical research associate but there are also clinical research project managers, feasibility specialists, medical writers and many more possibilities.
If you are interested in any of the above careers and would like me to dive into more detail in an upcoming post or if you would like me to cover a job that has not yet been covered, please let me know in the comments section.
Like always, I hope this was helpful!