Every pill, capsule, tonic, and cream passed over the counter by a pharmacist to an individual has gone a long way from concept to a point of sale.
Many medications that are even available without a prescription, such as cold, flu, or allergy aisle also undergo the same process.
Before drugs are prescribed and sold, they have to be proven effective and safe.
For this, pharmaceutical companies, health organizations, and universities put them through clinical study or trial process.
In the world of clinical trials, companies that financially support a research group that was picked to conduct clinical trials on the drugs is known as CRO or contract research organization.
Mainly, these organizations provide financial support to pharmaceutical development, biotechnology for medical devices, and agricultural industries.
With pharmaceuticals, in the process of drug clinical trials, drugs that weren’t approved for sale are given to chosen participants under much control.
Clinical trials require a lot of documentation, observation, analysis, and organization.
The administration of a clinical trial involves a team of professionals, which includes a clinical research associate (CRA).
They perform a function of a liaison between the CRO (for example, pharmaceutical companies) and the clinics conducting the study.
Since the clinical trial results should be entirely transparent and not impacted by the sponsor’s interest, the role of a CRA is critical.
Successful CRAs should be highly educated, detail-oriented, and able to clearly communicate both with clinical representatives and the sponsor.
- Work Environment of CRAs
- Clinical Team of a CRA
- Daily Responsibilities of CRA
- Required Skills & Knowledge of CRA
- Certification for CRA
Work Environment of CRAs
A CRA works both at sponsor locations and clinical sites.
During the clinical trials, they visit sites regularly, both physically and virtually, to ensure the proper record-keeping and progress on the side of the clinic.
CRAs often deal with multiple trials at the same time, which means they have to travel between these sites a lot.
Sometimes, they may be assigned to a specific geographical location, so the travel can be limited.
Clinical Team of a CRA
Typically, a CRA doesn’t contact directly with the participants involved in the study.
However, they should be able to collaborate with others, frequently interacting with the team at the study location and the supervisors of the study sponsor.
CRAs are in the middle of the top executives, starting with:
- Contract research organization (CRO) or sponsor.
- Principal investigator (PI).
- Clinical research associate (CRA).
- Clinical research coordinators (CRC).
In simple terms, a CRA focuses more on data, quality control, and accuracy while CRCs collect data and interact with patients.
On the YouTube channel “The Clinical Trials Guru”, Dan Sfera summarizes the profession of a CRA as follows: “CROs select various PIs across the country, and PIs make sure that sites are following good clinical practices and protocols.
They ensure this by hiring CRAs who look at all the recorded data and do not interact with patients when they are completing a site visit.”
Daily Responsibilities of CRA
The day-to-day responsibilities of a CRA depend in many ways on the stage the trials are at, which they are supervising.
So, below, we’ve gathered common responsibilities of a CRA throughout different stages of clinical research.
Before a Study
All clinical studies take place in properly equipped clinical locations.
CRAs play a significant role in picking the site for a study and may even suggest sites based on their experience.
They may also assess the applications of sites self-selected as suitable for a specific study.
Potential study sites are narrowed down by having them complete a feasibility survey.
Once the range of sites is narrowed down, CRAs make site selection visits to the locations that were chosen.
During these visits, they spend half a day confirming the feasibility study validity, observing the equipment and capabilities of the facility, and meeting with the team.
When the site visit is completed, CRAs make reports for the study sponsors and present their recommendations and findings to proceed with the research.
During a Study
After the site was selected, CRAs should ensure that the site is familiar with the required protocol of the sponsor and sets everything up properly to conduct the study.
During the study, the CRA makes site visits regularly to ensure that data is collected effectively and protocols are followed.
Based on the research, CRAs may visit sites virtually or in-person.
Recently, remote visit technology allowed CRAs to check all paperwork online.
And the in-person visits can be reserved for necessary interactions.
During the visits, CRAs ensure that the study goes on with good clinical practices all the time.
Finally, since the CRA acts as a liaison, building and maintaining positive relations is a significant part of the job.
During the trial, CRAs should effectively communicate with and assist the clinical staff in any appropriate way to ensure that the progress of the study is smooth.
End of a Study
When the study concludes or has to be ended (for example, when the enrollment in the study is low), CRAs usually make closeout visits.
During these visits, CRAs verify that all paperwork is orderly and both sides met the obligations.
The verification process may include ensuring that the trial drugs are destroyed or returned while all documentation is properly completed and the information needed to complete the final report for the sponsor of the study is compiled.
Required Skills & Knowledge of CRA
Given the responsibilities described above, it’s no surprise that CRAs should have a knack for detail.
Proper filing, documentation, and storage are essential parts of the job.
CRAs should ensure that both the clinic and sponsor understand their responsibilities at every stage of the study, as well as all procedures and policies, are being followed for successful data collection.
Additionally to being detail-oriented, good CRAs also maintain the ethics of the profession.
Clinical studies and trials can have great consequences for the sponsoring organizations, trial participants, and, eventually, consumers at large.
CRAs are an essential proctor for ethical issues and should stand up to any perceived transgressions.
Above everything, CRAs must know and be able to execute good clinical practices (GCP) successfully.
The GCP is the international set of standards developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
They provide the specifics on how to conduct drug trials with human subjects effectively and ethically.
The topics in the ICH are divided into four categories: efficacy, quality, safety, and multidisciplinary.
More detailed guidelines can be found on the ICH website.
Maintaining the GCP standards is a crucial part of the job of the CRA.
So not only should they know GCP but also be able to identify and implement them in a clinical setting.
Certification for CRA
Certification is not a legal demand to work as a CRA, but it can provide a significant advantage over the competition and help with career advancement.
CRAs are certified by two main bodies: the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP).
Association of Clinical Research Professionals (ACRP) – Certified Clinical Research Associate (CCRA) Certification
To obtain the Certified Clinical Research Associate (CCRA) certification, applicants should either:
- Have a high school diploma with at least 6,000 hours of experience.
- Be a licensed practical nurse (LPN), licensed vocational nurse (LVN), or registered nurse (RN), or hold an associate’s degree with at least 4,500 hours of experience.
- Have a bachelor’s degree with at least 3,000 hours of experience in the CRA role.
Also, they should submit proof of their current job description and a resume as well as pass the CCRA examination.
At least 24 hours of continuing education credits are required to maintain the certification.
Recertification is required every two years.
Besides the CCRA credential, ACRP also offers certifications for research coordinators, project managers, principal investigators, and an umbrella certification for clinical professionals.
Society of Clinical Research Associates (SOCRA) – Certified Clinical Research Professional (CCRP) Certification
To obtain the Certified Clinical Research Professional (CCRP) certification, applicants should either:
- Have a certificate in clinical research (undergraduate or graduate), a degree in science, health science, pharmacy, or a related field (associate’s or bachelor’s), plus at least one year of full-time experience.
- Have a degree in clinical research plus at least one year of full-time experience.
- Have at least two years of full-time experience as clinical research professionals.
Applicants have to pass the CCRP examination and get recertified every three years.
For recertification, 45 hours of continuing education credits are needed, in total.
The main difference between the SOCRA and ACRP certifications is that ACRP certified specifically CRAs but SOCRA certification can be useful for other types of clinical research professionals.