Clinical Research Roles: How to Become a Study Coordinator

A study coordinator is a central player in clinical research. In this article, we’ll go through the role of a clinical study coordinator, including their responsibilities, and required qualifications.

What is a clinical study coordinator?

Also known as a research coordinator or clinical trial coordinator, a study coordinator has in-depth knowledge of the complete study protocol, including the eligibility criteria, drug intervention, baseline measures, and primary outcomes. They work across the three major aspects of clinical research: study management, subject care, and patient advocacy.

What is the role of a study coordinator in clinical trials?

The principal role of a study coordinator is serving as a central point of contact for multiple stakeholders within a clinical study, transferring data, information, and concerns across to relevant trial personnel, as shown below. [ 1 ] They oversee the daily operations of clinical trials, working closely with the principal investigator (PI) and research team to ensure the study is conducted according to Good Clinical Practice (GCP) guidelines, protocol, and regulatory requirements.

Some of the responsibilities of a clinical study coordinator include but are not limited to the following:

• Recruiting and enrolling study participants, including everything from running campaigns through to randomizing patients
• Collecting informed consent and addressing any concerns participants may have
• Coordinating study visits and procedures; scheduling study visits, coordinating with study participants and healthcare providers to ensure they are available for visits, and ensuring that all study procedures are performed according to the protocol and GCP guidelines
• Maintaining accurate study, regulatory, and IRB and documentation, ensuring compliance and good clinical study practice
• Preparing trial documentation for IRB approval and other governing agencies
• Coordinating and documenting training sessions for research staff
• Overseeing inventory and medical equipment, ensuring trial sites have the appropriate supplies
• Writing case reports and reporting results to key stakeholders such as review boards and funding agencies
• Supervising research activities to ensure they comply with federal and local guidelines
• Documenting and reporting any adverse events or non-compliance issues participants may face
• Ensuring all ethical and legal guidelines are followed throughout the clinical trial

Study coordinator skills and qualifications

Academic requirements for study coordination include a Bachelor’s degree in Clinical Research from a CHEA-accredited institution or an undergraduate with a major in clinical research. However, many in this field also have a Bachelor’s degree in science, chemistry, biology, nursing, or other health science-related fields.

In addition to academic requirements, clinical experience is a significant factor in finding success in study coordination. Even though a study coordinator is not directly responsible for administering the trial’s intervention or personally handling patient care, many clinical research coordinator job description listings require expertise in healthcare and clinical settings.

Many who pursue a career in clinical study coordination start as research nurses as they already have a foundation in patient care. Advanced degrees such as a Master’s degree or Ph.D. are not necessary but are a bonus and can help secure a higher pay grade.

Certifications

The Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA) offer additional certifications that can boost qualifications, including:

• Certified Clinical Research Coordinator (CCRC)
• Certified Clinical Research Associate (CCRA)
• Certified Clinical Research Professional (CCRP)

A CCRC certification formally recognizes the research professional can facilitate and coordinate clinical research activities according to good clinical practice guidelines under the direction of a principal research investigator. [ 2 ]

A CCRA certification formally recognizes the research professional is experienced in supervising and monitoring progress and conduct on behalf of a study sponsor. [3]

Both certificates have two eligibility pathways, as described below:

1. 3,000 hours of verifiable clinical research experience
2. A clinical research degree and 1,500 hours of verifiable clinical research experience

The CCRP certification recognizes the research professional with the abilities and experiences to conduct clinical studies per international good clinical practice guidelines. [ 4 ]

It offers three eligibility criteria as listed below:

Category 1

• Have two years of experience as a full-time clinical research professional
• OR 3,500 hours as part-time experience in the last 5 years

Category 2

• Have an Associate’s, Undergraduate, or Graduate degree in Clinical Research
• AND one year of full-time clinical research experience OR 1,750 hours part-time

Category 3

• Have an Associate’s or Bachelor’s degree in health science, science, or pharmacy-related field
• AND an Undergraduate or graduate certification in Clinical Research with a minimum of 144 credit hours from a higher learning institution
• AND one year of full-time clinical research experience OR 1,750 hours part-time

Skills

A good clinical study coordinator also needs to demonstrate the following abilities:

• Excellent communication, interpersonal and organizational skills
• Leadership, time management, and motivational skills
• Collaborative skills with an ability to work independently
• Strong research skills and high attention to detail
• Analytical and critical thinking
• Problem-solving capabilities

Study coordinator training program

Several academic institutes and organizations offer clinical research training programs that prospective study coordinators can take to improve their skills. These include the following:

• Clinical Research Coordinator (CRC) with the CITI Program [ 5 ]
• Study Coordinator Training at the Research Compliance Center at UNC [ 6 ]
• Certified Clinical Research Coordinator Training with the Clinical Research Society [ 7 ]

Where to find study coordinator jobs

A clinical study coordinator works in CROs, drug development and pharmaceutical companies, and hospitals that participate in clinical trials.

Many of these companies and agencies will list an opening for a clinical research coordinator (job description included) on their websites and social media accounts, such as Facebook and LinkedIn. Other resources include job boards and online job directories.

Study coordinator salary

The mean clinical trial coordinator salary is approximately $50,735 per year, with a base salary ranging from $39,000 to $77,000. [ 8 ]

However, this salary can significantly increase with certifications and experience reaching upwards of $90,000 annually. Additionally, salaries vary greatly from state to state. For example, trial sites in California and Connecticut offer higher salaries due to the high volume of clinical research projects. [ 9 ]

Study coordinator job outlook

While the prospects of study coordination had slowed down considerably in 2020, it is back on the rise. Currently, the outlook for a clinical study coordinator is strong, particularly in regions that are seeing growth in clinical research. The demand for those with experience in multi-center trials and remote technologies is also high as clinical research moves towards a more patient-centric paradigm.