How to Become a Clinical Research Coordinator: Everything You Need to Know

Do you want to know how to become a Clinical Research Coordinator (CRC)? What does a Clinical Research Coordinator do? What qualities do CRCs need to succeed? You’ve come to the right place!

Today, the experts at Vitalief are here to guide you through everything you need to know. Let’s get started!

What is a Clinical Research Coordinator?

A Clinical Research Coordinator, commonly referred to as a CRC, is a person who organizes and manages clinical trials for pharmaceutical companies and academic institutions. These organizations rely on Clinical Research Coordinators to manage many aspects of their studies and make sure they’re done in compliance with all laws, regulations, and the study protocol. 

What is a Clinical Research Coordinator’s Job Description?

The basis of a clinical research coordinator’s job description is doing everything it takes to ensure a clinical trial runs smoothly. Some of the responsibilities this includes are:

  • Setting up clinical trial sites
  • Training the site staff and patients
  • Performing quality control checks throughout the study process
  • Recruiting participants through community outreach programs
  • Screening out ineligible patients at every step of the enrollment process
  • Managing the informed consent process

Clinical Research Coordinators typically work as part of a team that includes statisticians, regulatory coordinators, primary investigators (PIs), and other members of the clinical research staff. They often have managerial responsibilities too.

Managing the Informed Consent Process

CRC talking to patient

One of the most important tasks CRCs are responsible for is introducing the informed consent process to potential study participants. Without informed consent, clinical research cannot move forward ethically.

The informed consent process ensures that patients know the risks and benefits associated with a trial. It also provides the information necessary for them to make an informed decision.  Plus, it provides an open dialogue between everyone involved.

This process requires the CRC to provide participants with all the necessary information about the study, such as:

  • Aims and objectives
  • The nature of their involvement
  • The duration of the study
  • The risks and benefits associated with participation
  • Any other relevant details

The CRC must ensure that potential participants fully understand this information before they make the decision to participate in the study. 

Other Responsibilities

The CRC also assists in several other processes. These include:

  • Developing study protocols
  • Organizing meetings with investigators and other key stakeholders
  • Ensuring compliance with applicable laws and regulations
  • Maintaining accurate records throughout the course of the study
  • Monitoring safety procedures
  • Reporting any adverse events

The CRC, along with the Clinical Research Study Manager and the Regulatory Manager, may also be responsible for compiling and analyzing data from clinical trials and preparing reports to be submitted to ethics committees and regulatory bodies. 

What Skill Sets are Required to be a Good Clinical Research Coordinator?

As a Clinical Research Coordinator, you are required to understand the complexities of clinical trials, as well as the drug development process. The best candidates for this job understand laboratory procedures, have administrative and computer skills, and have excellent communication skills. Clinical Research Coordinators must be detail-oriented and able to work under pressure with strict timelines.

As a Clinical Research Coordinator, the following skills will help you succeed in your role: 

  • Emotional intelligence, empathy, and compassion for others who are participating in a clinical trial 
  • Detail-oriented and know how to read and follow a protocol 
  • Exceptional communication and interpersonal skills since you will interact with the research team, the primary investigator, clinical staff, and the study participants in written and verbal communications
  • Ability to multitask and excellent organizational skills
  • Curious, willing to learn, and an analytical mindset

A Clinical Research Coordinator’s job description usually includes administrative tasks such as preparing budgets, filing paperwork, and handling correspondence.

What Education and Training are Required for a Clinical Research Coordinator Role?

In most cases, Clinical Research Coordinators must have at least a bachelor’s degree in life sciences or public health, as well as one year of laboratory experience.

They must also have up-to-date knowledge of relevant scientific literature and an understanding of statistics and experimental design principles.

Clinical Research Coordinators often serve as mentors to other employees in their organization regarding regulatory compliance standards and ethical issues that may arise during clinical trials.

Certifications Required for Clinical Research Coordinators

Professional certification requirements vary by employer, state, and the type of work a Coordinator does. There are numerous certifications that are designed to build a CRC’s skills and knowledge.

Micro-credentialing, such as a badging program, helps to expand knowledge and provide unique training experiences that are specifically designed for certain professional roles. Rutgers has a great program that is specifically geared toward Clinical Research Coordinators. 

The Rutgers CRC Badging Program

The Rutgers Clinical Research Coordinator (CRC) Badging Program is an innovative program designed to provide certification and recognition for individuals who are looking to further their careers in the clinical research field. As part of the program, individuals must complete certain courses and demonstrate a deep understanding of clinical research protocols, practices, and standards.

To meet the requirements of the badging program, candidates will gain knowledge of the Clinical Research Coordinator job description. This includes understanding the essential functions of a research coordinator, such as:

  • Developing, managing, and monitoring research protocols and studies
  • Collecting and analyzing data
  • Preparing reports and presenting results
  • Maintaining accurate records and databases
  • Troubleshooting any issues that may arise during the course of the study. 

The Rutgers Clinical Research Coordinator Badging Program is a great way to demonstrate your expertise in the field of clinical research coordination and become more competitive in the job market. By obtaining your CRC badge, you can show employers that you have the knowledge and skill necessary to effectively lead clinical research projects.

Professional Career Paths for Clinical Research Coordinators

As a Clinical Research Coordinator, there are many opportunities for professional development. You interact with people in several different roles, from nurses to administrators. This exposure to diverse roles will enable you to explore a myriad of professional opportunities and help you determine the next step in your professional journey. 

If you think you might be interested in pursuing this career path, now is a perfect time! Vitalief is always looking for strong candidates for this role. Check out our CAREERS page to see the different roles we are seeking to fill!

A Day in the Life of a Clinical Research Coordinator

We recently got the chance to speak with Jeimy Rosado, Clinical Trials Program Manager at Vitalief. Jeimy is new to Vitalief, but she is not new to clinical trials. She brings over a dozen years of practical experience in clinical trial administration. Jeimy is very energetic and clearly enjoys her work. Her enthusiasm is contagious. As we talked, it was obvious that Jeimy is thoughtful about her career path, purpose, and the broader clinical trial profession. In this discussion, she shares some of her practical experiences and perspectives on clinical trial management. 

What is a Clinical Research Coordinator?

The job of a Clinical Research Coordinator (CRC) is to ensure that a clinical trial, be it observational or interventional, is well conducted and follows GCP guidelines. A CRC typically must wear many hats, but screening patients is probably one of the first/most important tasks a CRC conducts because it determines whether a patient is eligible for a particular trial. The inclusion/exclusion criteria must always be reviewed with the Principal Investigator or Sub-Investigator prior to enrolling a patient in a study. 

What does a CRC do in a typical day?

CRCs typically interact with patients, technicians, nurses, physician assistants, doctors, and other administrative personnel. If it is determined that the patient meets the criteria for a study, the CRC will then conduct the Informed Consent Process with the patient and schedule the follow-up telephone/clinic visits to collect the data needed for the trial.

The CRC must then:

  • Enter the data in the relevant systems
  • Ensure that the proper billing is done for the trial
  • Answer queries issued by the sponsor to clean up the data
  • Do daily checks for patients’ adverse events in the Electronic Medical Record system

Because there are so many moving parts involved in conducting a clinical trial, it is the CRC’s job to prioritize his/her daily tasks and the order in which each should be completed.

What do you like the most about being a CRC?

I am happy to be able to help a patient (albeit in a small way) find alternative/better solutions for the treatment of a disease. That is the most rewarding part of the job; feeling as though you are contributing to the greater good and making a difference.

What do you find most challenging?

One of the most challenging aspects of working as a CRC is ensuring that while the clinical trial is being conducted the data collected is of quality and that small things do not fall through the cracks. There are many tasks to be completed on any given day, and the pace can be overwhelming.

Another challenge involves the Principal Investigator’s (PI’s) availability to review, sign, and assess the data and any adverse events that occur while the trial is being conducted. It is crucial that this gets done in a timely fashion as there are deadlines imposed by the sponsor, especially during times when the data needs to be locked to be presented to the FDA.

How did you get into this field? What drew you to it?

I was interested in public health but wanted to take part in a project like the Peace Corps. I decided to take a chance and get involved in the field of Public Health at a time when the job market was awful. I was struggling to find work after the market crash of 2008/2009. I realized that in this field there will always be jobs available and that it is very rewarding if you pursue it for the right reasons.

I have gotten so much professional and personal satisfaction working with clinical staff to help patients. I have learned so much. Because each trial is different and each patient population has different needs, I continue to learn and feel that I gain so much from that experience. So here I am, 13 years later!

What skills do you need to be a good CRC?

Having great interpersonal skills is vital for CRCs to do their job. This is important, as the CRCs will interact with patients, administrative, and clinical personnel daily. Roadblocks will always come up but good communication throughout those interactions always helps. 

What advice would you give to someone entering the field? 

  • Be prepared to be challenged regularly; a CRC’s job is not easy. The job can be stressful but also fulfilling!
  • Work on building relationships with both the clinical and administrative personnel, as they will all be an integral part of your day-to-day activities.
  • Do not be afraid to ask for help from your peers, management, the PIs, clinical staff, etc.
  • Feel confident in your ability to make decisions as you will not always have someone readily available to assist you.

Why did you choose Vitalief as the next step in your professional journey?

During my job search, I interviewed with multiple companies and spoke with several hiring managers. I decided to join the Vitalief team because I believe in their mission. The company’s “people first” mantra is why I felt it was the right career move for me.

It is so motivating to know that Vitalief is genuinely invested in creating a thriving career path for each one of its employees. As a functional service provider (FSP) supporting clinical trials, the company is constantly rethinking current practices and envisioning new solutions that drive improved outcomes. I was seeking an entrepreneurial career that would support my personal and professional growth and I found it with Vitalief.

Grow Your Clinical Trial Management Career with Vitalief

Jeimy’s insight and experiences help us to better understand the responsibilities, challenges, and personal and professional advantages of being a Clinical Research Coordinator. It is clear why she is good at her job and making her mark in the clinical trial industry. 

If you are a CRC interested in learning more about Vitalief or joining our team of clinical trial coordinators in New York, New Jersey, and Pennsylvania, send a note to joinus@vitalief.com or contact us today.