Clinical Research Coordinators (CRCs) play a very important role in clinical trials because these professionals are the right hand of the Principal Investigator (PI). The CRCs are responsible for ensuring that the objectives of the clinical study are accomplished.
Today, with the growth of clinical investigation, the demand for CRCs has increased in the United States.
“There are over 33,631 Clinical Research Coordinators currently employed in the United States,” explain the Zippia Career Experts, when talking about the current boom in this area.
For this reason, the clinical research industry agrees that the CRC is considered the heart and soul of a clinical trial, even though the PI is in the end who has the overall responsibility for the management of the processes and procedures involved.
But what are the tasks and responsibilities that a CRC undertakes? The aim of this article is to define who CRCs are and why their collaboration in clinical trials is certainly essential.
What Is a Clinical Research Coordinator (CRC)?
The CRC is the lead professional who assumes the control of the clinical trial at the hospital under the auspices of the PI.
Serving as a liaison between the enrolled patients, the patient care team, and the PI, the main duty of this professional is related to patient recruitment, patient well-being, as well as trial development and the function of providing information.
In addition, when conducting clinical trials, the CRC must ensure compliance with Good Clinical Practice (GCP), which is an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials involving human subjects. [1]
Consequently, the tasks and responsibilities of the CRC are extensive. In fact, the main requirement to become a CRC in the United States is to be a specialist with at least a four-year degree in a field such as medical technology, microbiology or public health administration. However, some employers may require an additional two-year master’s degree, especially for management positions. [2]
If the clinical trial is intended, for example, for patients admitted to an intensive care unit (ICU) or surgical patients, the CRC must be specialized in the process of obtaining informed consent with unconscious and intubated patients [3], or with volunteers in a particular emotional state, such as anxiety or fear.
Why Are Clinical Research Coordinators so Important in Clinical Trials?
CRCs are of paramount importance in the clinical study since the smooth running and quality of the study depends on these professionals, who control all the processes and contribute to making sure that the clinical trial not only flows without any problem but also meets the objectives set.
The following are fundamental contributions of the CRCs to the process: [4]
- Getting the ideal participants and gaining their trust, as the CRC must monitor the selected patients and look after their well-being during the study.
- Providing an accurate explanation of the clinical trial to the patient and key research staff, while maintaining harmony.
- Understanding the needs of the investigators and communicating with the surgical and nursing personnel.
In summary, the CRC is crucial as he or she is in charge of the team and procedure management. Below, their main tasks will be explained in more detail.
What Are the Main Tasks and Responsibilities of Clinical Research Coordinators?
In most articles about the role of the CRC, and even in numerous job postings in the United States, the authors agree that the CRC’s primary responsibility is the protection of the human subjects participating in the trial.
In addition, these coordinators are also responsible for the site staff’s compliance with the protocol, since the CRCs must keep track of study activities to verify that all local, state and national regulations, as well as institutional policies, are correctly followed.
While the responsibilities are indeed demanding, the task list is not far behind. The following is an overview and explanation of the main tasks assigned to a CRC during various steps of the clinical research. [5, 6]
Feasibility and Subject Recruitment
- Preparation of advertisements and didactic material, and conduct of campaigns to recruit subjects for the study in compliance with the protocol.
- Upon recruiting participants, sending notifications of all details of the study and assisting patients.
- Arrangement of doses of certain drugs, space for study equipment and other clinical trial related material.
- Monitoring the enrollment status of participants.
- Proper management of subject registrations.
Patient Care
The CRC interacts with the PI to ensure that the patient receives appropriate medical evaluation and care when needed, and alerts the PI of any serious adverse events that occur during the study. Therefore, as stated above, the CRC must visit patients and be aware that all procedures comply with the protocol.
Informed Consent and IRB
One of the key tasks in a clinical trial is to obtain the signed informed consent document from the patient, which protects the rights of those subjects participating in the study.
According to the federal law of the US, all research studies involving humans must be approved by the Institutional Review Board (IRB). The CRC is responsible for the IRB submission.
For this reason, the CRC is due to draft the informed consent document with all the aspects required by the study sponsor and the IRB, which will be listed further in this article.
In other words, this professional serves as a liaison between the IRB and the study sponsor (i.e., a biotech or pharmaceutical company), since the IRB must approve the informed consent prior to the start of the study.
To this extent, the significance of the role of the CRC as a communicator is decisive.
In order to understand the scope and commitment of the informed consent document, here are the contents and major points to be mentioned in this sheet:
- Statement and explanation that the purpose of the study is research, including the duration of subject participation and the description of procedures.
- Description of any reasonable risk or discomfort caused to the subject.
- Description of any benefits to the subject or others that can reasonably be expected.
- Disclosure of appropriate alternative procedures or treatments, if any, that might be advantageous to the subject.
- Description of measures of confidentiality of the subject’s identity.
- Explanation of minimal risks to the patient, compensation and medical treatment available in the event that prejudice occurs.
- List of contact people for questions about the research and the rights of subjects in the event of research-related injuries.
- A statement that participation is voluntary, not mandatory, and that interruption during the trial cannot be penalized.
Clinical Trial Agreement
The Clinical Trial Agreement (CTA) is another task in which communication plays a central role. The CRC must guarantee that the study sponsor, the PI and the site where the clinical trial is conducted come to good terms with regard to the contractual clauses found in the CTA.
The site where the clinical trial is carried out negotiates the CTA to conform to its policies and procedures. Therefore, the participation of each party is necessary for a successful agreement.
What exactly has to be outlined here? This contract should include indemnification, confidentiality, publication, intellectual property, insurance, data security and control boards, subject injury, applicable law, and termination clauses.
Budget and Costs
Moreover, there are administrative responsibilities dealing with financial issues of the trial, among which are the following:
- Collaboration with the institutional officer in budget negotiations.
- Development of detailed cost analysis and monitoring of payments.
- Negotiation of the budget with the sponsor and review of trial expenses.
Processing and Shipping of Laboratory Samples
Very often, in a clinical trial there are some biological samples to be taken from participants. At this stage, the CRC has to provide these services:
- Request, collection, labeling, storage, and shipment of biological samples.
- Communication with central laboratories to ensure the arrival of biological material.
Reports and Adverse Events
Reporting and communication are key tasks that the CRC has to carry out. This includes:
- Preparation of trial-related paperwork such as protocol worksheets, adverse event (safety) reports, and progress reports.
- Keeping communication with the sponsor and the appointed CRO.
Case Reports and Electronic Data Capture
After collecting the clinical data from source documents, the CRC enters the information into the electronic data capture (EDC) system, which is an online database that allows sponsors to receive, clean, and analyze the clinical data from sites.
If you wish to know more about EDC, you can read the following article: “What Is an Electronic Data Capture (EDC) System in Clinical Trials?”
Closing the Study
Finally, the CRC closes the clinical trial by completing IRB study close-out documentation, in accordance with the local IRB, and appropriately notifies study subjects, research teams, and pharmacies.
For this purpose, the CRC works together with the sponsor’s clinical monitor to complete outstanding monitoring findings and queries. Also, the CRC must comply with record retention policies of the Food and Drug Administration (FDA), the ICH, and the clinical trial agreement. [6]
Conclusion
In conclusion, the CRC is a clinical research professional who assumes a challenging position of great responsibility, steady observation, and dedication. CRCs play a key role for the success of a clinical trial.
FSP Clinical is a provider of CRCs for clinical trial sponsors —biotech and pharmaceutical companies— conducting clinical studies at hospitals located in the US. We can provide CRCs in most US cities.
References:
[1] ICH: E 6 (R2): Guideline for good clinical practice – Step 5 (europa.eu)
[2] How to Become a Clinical Research Coordinator (Clinical Trial Manager) (mhaonline.com)
[3] and [4] Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients (nih.gov)
[5] Roles and Responsibilities of Clinical Research Coordinator | JLI Blog (jliedu.com)
