Clinical research is a sector that cannot be executed by one type of professional. A collection of roles are involved in the process of a clinical trial, all contributing a distinctive set of skills specific to their function to ensure the success of the trial.
Those working within clinical trials can include Sponsors, Doctors (called Principal Investigators), Data Managers, Pharmacovigilance Consultants, Coordinators, Research Assistants, Nurses, Biostatisticians, Regulatory Authorities and Clinical Research organisations. Every individual involved must collaboratively work together to protect the participant and aid the smooth running of the trial.
Two significant roles within the Clinical Research team are that of the Clinical Research Associate and the Clinical Trial Administrator. Both roles hold equivalent importance yet involve varied duties and require a different combination of attributes from the professional.
A Clinical Research Associate or CRA is a healthcare professional who acts on behalf of the Sponsor. A Sponsor is ‘an individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of clinical trial’ (ICH GCP 1.53). The Sponsor may contract a person or organisation (CROs) ‘to perform one or more of a sponsor’s trial-related duties and functions’ (ICH GCP1.20).
However, the Sponsor retains full responsibility for the trial conduct. CRAs are responsible for overseeing and supporting the administration and the progress of the trial site; ensuring all is conducted in compliance with the protocol, Good Clinical Practice (GCP) and applicable regulations.
The CRA’s responsibilities may differ depending on the Sponsor/CRO that the professional is working for. However, generally, they are involved in the set-up, monitoring and closing- down of clinical trial sites, working closely alongside Principal Investigators (PIs) and Study Coordinators (SCs), amongst other research team members.
A CRA will typically perform 4 types of visits; Site selection, Site Initiation, Interim Monitoring and Close Out Visits. These visits occur before, during and after a trial. The first of the visits is the Site Selection visit, of which the purpose is to assess the adequacy of the site to conduct a study.
The second is the Site Initiation Visit, where the CRA will usually train site staff on the protocol and all study-related procedures. Interim Monitoring Visits occur at regular intervals by monitoring compliance with the protocol, ICH GCP and local laws and regulations, ensuring participant safety is protected. Close Out Visits are carried out to terminate all study-related activities at the site and ensure all documentation is in order. At the end of each visit, the CRA will prepare follow-up emails and reports, disclosing any queries and proposed corrections.
Typically, a CRA is field-based, working on trial sites 3-4 days a week. The locations of these sites can vary from being all over the country to all over the world, hence anyone considering a career as a CRA must be open and flexible to travel. Any off-site duties, such as follow up emails/reports and general administration, are usually performed at the home of the CRA. They have the freedom to manage their own time, whilst making sure to complete all the tasks by set deadline.
It is vital for a CRA to have excellent organisational and time management skills, as clinical trials can be extremely fast-paced. If deadlines are not met or standards are not maintained, it could have a negative impact on the progress, validity and success of a trial or even jeopardise the safety of the participants. Therefore, it is key for a CRA to be able to communicate clearly to a variety of professionals, especially when solving queries or dealing with patient data.
A Clinical Trial Administrator or CTA works for the Sponsor or CRO (Contract Research Organisation) and assists the CRA and/or Project Manager in the day-to-day management of the clinical trial. For those who are entering the world of Clinical Trials looking to kick-start and develop their career, the CTA role is the perfect introduction and starting point.
In contrast to the role of a CRA, the role of a CTA is office-based and involves the preparation, maintenance, tracking and archival of study documentation, as well as the processing of data collected throughout the duration of the trial. A CTA must be familiar with and adhere to the guidelines of the ICH GCP (International Council for Harmonisation Good Clinical Practice).
These guidelines are in place to ensure the public of the protection of their safety, rights and well-being. ICH GCP Section 8 lists all the ‘essential documents’ required before, during and after a trial. These documents ‘serve to demonstrate the compliance of the investigator, sponsor and monitor the standards of Good Clinical Practice and with all applicable regulatory requirements’ (ICH GCP 8.1).
A CTA must be able to file these essential documents in a timely and accurate manner to ensure the successful management of a trial. The CTA is also responsible for the set up and maintenance of the Trial Master File (TMF); a collection of the essential documents, which when well-kept, ensure the efficient management of trials and facilitate the reconstruction and evaluation of the specific conduct of the trial during any audit or inspection process. The TMF must be present before, during and after the trial and must be accessible to those permitted and competent authority.
These are just some of the many duties and responsibilities that CRAs and CTAs are accountable for. Each position is pivotal to the effective and efficient conduct of clinical trials. With both positions, no day is the same. Priorities may change, and it is up to the CRA/CTA to meticulously determine how to adapt and deal with normal everyday tasks as well as urgent matters that may come up at any time.
It is also essential that CTAs/CRAs have everything in place as the investigator site/Sponsor could get audited and/or inspected at any time. CRAs/CTAs are able to get gain a broad experience with the breadth of professionals, therapeutic areas and protocols that they get to work with. You will never be bored!