Contact us if you need to hire clinical research coordinators (study coordinators) or data entry staff in Spain for clinical trials.
Clinical research coordinators (CRC) carry out very valuable and fundamental work for the correct development and success of a clinical trial.
The role of the clinical research coordinator (also known as study coordinator) focuses on the coordination, management, and supervision of various essential tasks related to patients participating in clinical trials and the clinical data that is generated.
In this article we will explain in more detail the tasks performed by clinical trial coordinators and specifically we will analyze the advantages of hiring study coordinators in Spain via an outsourced (Functional Service Provider – FSP) model.
The important role of clinical research coordinators
Among the various persons and roles that are involved in the development of a clinical trial, at the hospital’s side one of the central figures is that of the clinical study coordinator.
The clinical research coordinator carries out her activity within the hospital facilities where the study is performed, and is in charge of coordinating the processes related to patient recruitment and follow-up.
The trial coordinator is part of the site’s local research team, and works closely with the principal investigator and other team members (e.g., nurses, pharmacists, co-investigators).
Thanks to the clinical research coordinator, the processes related to the enrollment, treatment, and follow-up of study participants can be properly carried out, and they are also a vital point of contact for sponsors and their collaborators (e.g., CRO’s monitors and clinical project managers).
The professional profile of clinical research coordinators
Usually, a clinical research coordinator’s profile, although not always necessarily so, is linked to degrees related to health sciences, biology, biochemistry, pharmacy, and similar educational programs.
The clinical research coordinator’s daily tasks
The tasks typically performed by clinical study coordinators are as follows:
- Control of procedures and management of the clinical trial daily schedule.
- Daily review of patient records for potential candidates to participate in clinical trials.
- Completion of electronic case report forms (eCRF) and resolution of queries.
- Notification of adverse reactions due to investigational drugs.
- Sending and receiving biological samples, medication and documentation related to each clinical trial.
- Preparation and submission of medical images (e.g. DICOM radiology files).
- Maintain correspondence with the sponsor, monitors, and carry out all the tasks and procedures necessary for initiation, monitoring, and close-out visits.
- Apply the rules of good clinical practice (GCP), as well as the relevant standard operating procedures (SOPs).
- Maintenance of the investigator’s file.
- Dispensing medication for each clinical trial, if required, from the hospital pharmacy.
- Management of the local documentation of clinical trials.
- Periodic reports on the status of the studies being carried out.
- Prepare site documentation for sponsor audits and inspections performed by the regulatory authorities.
The interaction of the trial coordinator with the Principal Investigator and the research team
As a member of the research team, the clinical trial coordinator maintains close communication with the Principal Investigator and the rest of the site’s team working on the study.
For example, one of the tasks of the study coordinator is to schedule and coordinate the visits of patients to the hospital facilities to undergo tests, receive the trial experimental treatment, and have biological samples taken.
In all these processes, the trial coordinator maintains close communication with researchers, nurses, and pharmacists, among others.
The interaction of the trial coordinator with the sponsor and/or CRO
At the same time, study coordinators act as a contact point for the parties that manage the clinical trial from outside the hospital, that is, the sponsor and/or its contracted CRO.
In the monitoring and supervision tasks carried out by the sponsor (often through a CRO), the study coordinator is the communication link between the site and the sponsor/CRO.
For example, the monitoring visits carried out by the CRAs designated by the sponsor are managed by the study coordinators, who are in charge of providing the CRAs with the data they need.
Clinical data entry in the electronic data collection (EDC) system
Clinical trial coordinators have various functions and one of them is related to the introduction of clinical data into the study database, which is known as the electronic data capture (EDC) system (sometimes called electronic case report form; eCRF). An EDC system is essentially a web application in which certain data from patients’ medical records are recorded.
The use of the term “Data Entry” is worth mentioning, as it refers to the person in the hospital dedicated more specifically to the entry of clinical data in the EDC platform. In this sense, a distinction can be made between the role of the trial coordinator and that of the Data Entry person. However, sometimes these two roles are assumed by the same person at the clinical site.
The rapid and continuous entry of data into the EDC of the trial is essential, so that sponsors can analyze the data on time to reach their conclusions. Related to this, it is highly important that the data of the patients included in the EDC can be refined through queries (issued by the sponsor) to rectify possible errors and discrepancies. Therefore, the work of the study coordinator or Data Entry in the resolution of queries will have an important impact on the robustness of the final research results.
The importance of clinical trial coordinators in audits and inspections
The audits requested by clinical trial sponsors and the inspections conducted by the regulatory authorities require that the hospitals where the studies are carried out maintain a large amount of well-updated and organized documentation and data.
Trial coordinators play a critical role in keeping the clinical study ready for potential audits and/or inspections. When these review activities take place, the study coordinators make sure that all the documentation of the clinical site is updated and complete, in order to pass the pertinent verifications.
The difference between a Clinical Research Coordinator and a Clinical Research Associate (CRA)
It is important to highlight the difference between a clinical research coordinator and a CRA. Although both roles deal with related aspects in the context of a clinical trial, the study coordinator carries out her work within the hospital facilities, being a member of the local research team. On the contrary, a CRA is an external person (who is not part of the research team of the clinical site) dedicated to monitoring tasks, and who is usually part of the staff of a CRO that works for the sponsor.
Hiring clinical trial coordinators (provided by a CRO) through outsourcing
Although it is common for study coordinators to be hired by hospitals as their own permanent payroll personnel, there is also the possibility that hospitals may choose to incorporate external study coordinators provided by clinical research organizations (CROs).
This outsourcing model, in which the trial coordinator is part of the CRO staff, but performs her functions within the hospital as external personnel, is becoming more and more frequent, with the main advantage being administrative simplicity and hiring flexibility. Using this formula, the site can have the study coordinator with the level of dedication it needs at a given time, avoiding bureaucratic internal hiring processes that are sometimes complex.
Sofpromed services: Provision of external clinical trial coordinators for hospitals in Spain
Sofpromed is a clinical research organization (CRO) that provides clinical trial coordinators and data entry personnel as an outsourced service for hospitals throughout Spain.
We have the capacity to facilitate study coordinators and staff for data entry, located in the majority of Spanish cities (Madrid, Barcelona, Valencia, Seville, Murcia, etc.), with different degrees of experience and specialized in various therapeutic areas (oncology, cardiology , infectious diseases, etc.), through a flexible and convenient hiring model that allows immediate incorporation to the hospital team during the period of time that is necessary.
This hiring model is simple and is based on a fixed monthly fee, according to the agreed monthly workload.
For more information on hiring clinical trial coordinators or data entry personnel in Spain, please contact us: info@sofpromed.com / Tel: +34 607939266.
