Clinical research is a field that can be difficult in and of itself, so it is essential to understand the knowledge and skill requirements for the various roles. A healthcare professional that oversees various duties for clinical trials and other kinds of medical research is a clinical research associate (CRA)
The CRA is responsible for carrying out the necessary task of clinical trial monitoring, which also includes,
- Ensure to protect the rights and welfare of human subjects.
- Report trial data that is accurate, complete, and verifiable from source documents.
- The trial is under the approved protocol and amendment(s), GCP, and the applicable regulatory requirement(s).
According to the Good Clinical Practice guidelines, clinical trial monitors should be well trained, possess the scientific and clinical knowledge necessary to monitor the trial, and have their credentials documented.
Before moving into the topic, let’s first understand clinical trial monitoring.
What is clinical trial monitoring?
Clinical trial monitoring assures that a clinical trial conforms with the protocol, SOPs, the principles of GCP, and the clinical trial regulations. Clinical trial monitoring helps to ensure that,
- The rights and welfare of human subjects are protected.
- The trial data reported is accurate, complete, and verifiable from the source documents.
- Confirm that the clinical trial is under the approved protocol and any amendments with GCP and relevant regulatory requirements.
Who is a clinical research associate (CRA)?
A healthcare professional that oversees various duties for clinical trials and other kinds of medical research is a clinical research associate (CRA), also referred to as a clinical monitor or trial monitor.
Good clinical practice recommendations mention the primary responsibilities of the CRA for monitoring clinical trials, such as those created by the International Council for harmonization of technical requirements for pharmaceuticals for human Use.
A CRA might later advance to the positions of Feasibility Leader, Study Start-up Leader, Project Manager, and Project Director at a pharmaceutical company or contract research organization.
A CRA frequently needs to have a degree in the life sciences, be knowledgeable about regional laws, and engage in clinical practice. A clinical research associate checks clinical site activity conducts on-site visits, evaluates case report forms (CRFs), and interacts with clinical research coordinators to verify that the clinical trial is under the protocols.
Clinical research monitors also uphold the security and welfare of clinical trial participants. A CRA must also ensure that adverse events are recorded and reported and that the scientific integrity of the data is protected.
What are the responsibilities of clinical research associate (CRA)?
- Builds trusting relationships on trial sites and confirms those relationships remain constant throughout the trial.
- Manages and monitors clinical trial sites following the site monitoring plan, protocol, local laws & regulations, sponsor policy, and ICH-GCP.
- A thorough understanding of the study protocol and associated processes.
- Collaborates with other sponsor positions to oversee several duties to attain “Site Ready.”
- Takes part in and contributes to site selection and validation.
- Uses several methods to carry out remote and on-site monitoring and oversight tasks to confirm that the data generated at the site is complete, accurate, and unbiased.
- Protection of subjects’ rights, safety, and wellbeing
- Conducts site visits, validation, commencement, monitoring, and promptly creates detailed and accurate visit and non-visit contact reports.
- Gathers, examines, and keeps track of the regulatory papers needed for research start-up, maintenance, and closeout.
- Discusses matters about protocol conduct, hiring, retaining, protocol deviations, regulatory documentation, site audits and inspections, and overall site performance with investigators and site employees.
- Identifies, evaluates, and fixes performance, quality, or compliance issues at the site and escalates as necessary following the team’s stated escalation procedure.
- Working with the manager and at the regional level.
- Manages and maintains data, records, and numerous other systems promptly and appropriately.
- Acts as a process Subject Matter Expert (SME), a mentor or buddy for the team, and shares best practices as necessary or appropriate to add to team expertise.
- As required, assist with or coordinate audit and inspection efforts.
- Contributes to finding new suitable sites and collaborates closely with them to build strong clinical research capabilities.
Before appointing a clinical trial assistant, what education and skills do you need to check?
- It would be preferable to have biology or science-focused bachelor’s degree.
- Experience in clinical research of at least two years, including work as a clinical trial assistant, a study coordinator, a regulatory CTC, etc.
- Fluent in both spoken and written English and the local languages, with good communication skills that include the capacity to comprehend technical data.
- Developing the capacity to facilitate the presentation of technical information.
- Good working knowledge of clinical research, clinical trial phases, current GCP/ICH, and national clinical research laws and regulations.
- Excellent knowledge of the ability to work within national, regional, and global clinical research guidelines.
- Develop site management skills, such as managing patient recruiting and site performance through skill monitoring and independent professional judgment.
- Good IT abilities, including the capacity to learn new IT applications on different devices and the ability to use MS Office and several clinical IT software on computers, tablets, and mobile devices.
- Able to collaborate with other seasoned research professionals to build expertise across several protocols, sites, and therapeutic modalities.
- High sense of urgency or accountability with the help of your line manager, be able to prioritize and manage several activities at once in a changing environment.
- Works well in a multicultural matrix environment with the capacity to build and maintain culturally sensitive workplace relationships.
How to find a clinical research associate (CRA) for your Thailand clinical trial?
Finding the best monitor for your clinical trial is imperative because clinical trial monitors play a critical role in a clinical trial. As we mentioned above, there are numerous factors you should consider before selecting the CRA for your clinical research. Credevo helps you in finding the best CRA’s for your clinical trials