Clinical Trials – The Role of the Coordinator

Clinical trial coordinators

What is a Clinical Trial Coordinator?

A clinical trial coordinator (also known as a clinical research coordinator or a study coordinator) is a person responsible for performing a variety of activities essential to the conduct of clinical trials at a research site. They are professionals who are trained in the conduct of research involving humans (i.e.: Good Clinical Practice), typically with a background in healthcare and/or research, such as a research nurse, a researcher with a biomedical science degree, or other health professional.

Coordinators are the main point of contact for research participants. They are vital for ensuring the safety and wellbeing of participants throughout their clinical trial journey. Coordinators are also the main point of contact for the study sponsor’s project management team. They can be involved in many study set-up activities at the trial site, such as ethics submissions and preparation of the site study file and source documents, as well as management of study at the site, including arranging meetings and invoicing.

Coordinator Responsibilities

Clinical trial coordinators perform a variety of research activities. This article will focus on those activities directly involving research participants.

Participant Recruitment

Clinical trial coordinators assist in finding patients or healthy volunteers who may be eligible to participate in a study. They may even be involved in the creation of recruitment materials, such as newspaper articles, social media advertisements, and online surveys. Potential participants can ask to speak with a clinical trial coordinator to get more information about a trial before applying.

Pre-Screening

Clinical trial coordinators often perform pre-screening. This is when they contact potential participants who have applied for a clinical trial or who have previously registered their interest to do suitable trials. The coordinator will provide information about the trial and ask a series of questions to determine the person’s eligibility to join a trial. Potentially eligible participants will then be booked in for a screening visit at the research site. They may also be sent a copy of the participant information sheet, which contains more information about the trial, as well as a consent form that is to be completed at the research site.

Screening & Informed Consent

At the screening visit, patients or volunteers are provided with in-depth information about the trial which they will then discuss together with the research doctor (known as an investigator) during the process of informed consent. The investigator determines whether the trial is suitable for the participant and whether they meet the eligibility criteria for the study. Some studies have very specific inclusion and exclusion criteria depending on the treatment target and phase of the trial.

For example, for chronic pain studies, researchers generally look for people who have had pain for at least 3 months that has not been resolved with conservative treatments. They also look for people who have a moderate to severe level of pain so that it is possible to determine whether any improvements following a treatment are statistically significant.

Clinical trial screening of a patient

Running the Clinical Trial

Coordinators are responsible for running the clinical trial according to the study protocol. Together with the investigator, their work ensures the safety of the participants and the integrity of the data collected.

They perform a range of different tasks, such as:

  • Managing ethics submissions;
  • Maintaining essential documents in the study site file;
  • Creating study specific data collection forms;
  • Scheduling participant study visits;
  • Administering participant questionnaires for data collection;
  • Dispensing trial medication;
  • Recording vital signs;
  • Taking pathology samples such as bloods and doing ECGs;
  • Entering the information collected into secure electronic data capture systems that is later used for analysis;
  • Arranging regular monitoring meetings.
GCP - Medical Care of Trial Participants - Newcastle Research Institute - Genesis Research Services

Coordinators also help to record any adverse events or symptoms that participants may experience while on study treatment. This information is collated to provide a safety profile of the drug or device being studied.

Coordinators act like a bridge between the participant and the study doctor, as well as other health care providers, including hospitals, imaging and pathology sites.

In summary, clinical trial coordinators play a vital role in the conduct of a clinical trial. They perform a wide range of duties, including study start-up activities, ongoing study management, and providing care and coordination of participants at every stage of their clinical trial journey.  

References & Resources:

  1. Davis AM, Hull SC, Grady C, Wilfond BS, Henderson GE. “The invisible hand in clinical research: the study coordinator’s critical role in human subjects protection.” J Law Med Ethics. 2002; 30(3):411-419. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4819323/ (free)
  2. Kadam RA. “Informed consent process: A step further towards making it meaningful!” Perspect Clin Res. 2017; 8(3):107-112. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543760/ (free)
  3. Sonstein SA, Jones CT. “Joint Task Force for Clinical Trial Competency and Clinical Research Professional Workforce Development.” Front Pharmacol. 2018; 9:1148. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6198073/ (free)