As clinical research advances, the role of the Clinical Research Associate (CRA) continues to be central and increasingly important.
In this article you will learn about:
CRAs are essential for the successful conduct of clinical trials, as they ensure adherence to protocols, regulatory standards, and GCP guidelines.
In this article, we will look at what a CRA does in clinical trials and highlight their key roles in improving medical research and healthcare.
We will also discuss how you can hire a freelance CRA in Slovakia through a contract with Sofpromed.
In addition, we will provide hourly rates for freelance CRAs in Slovakia at the end of the article.
What Does a Clinical Research Associate (CRA) Do?
In today’s rapidly evolving biotechnology and pharma landscape, where cutting-edge therapies are being developed to meet unmet medical need, a critical role for CRAs is to collaborate with researchers, scientists, and other professionals to advance new treatments in different therapeutic fields.
A CRA’s main job is to oversee and manage clinical trials, making sure they are conducted according to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
By working with investigators and study coordinators as well as site staff, a CRA helps to ensure clinical trials are conducted properly and data collection is accurate.
Here are some of the key tasks that a CRA performs:
Clinical Trial Approvals and Site Contracts
Senior CRAs can prepare clinical trial applications and submit them to national regulatory authorities and ethics committees.
These CRAs have experience negotiating study contracts and can assist sponsors in this process, which requires a great deal of local expertise.
Senior CRAs with experience in regulatory and contracting can manage the entire trial launch process, obtaining all the necessary initial permits and agreements.
Site Visits and Monitoring
One of a CRA’s primary duties is to perform site qualifications, initiation, periodic monitoring, and closure visits to investigator sites.
During these visits, the CRA verifies compliance with study protocols, guidelines, and relevant regulatory guidelines.
CRAs review and verify critical documentation and source data to ensure the quality and accuracy of clinical trial data.
Collaboration with Study Personnel and Resolution of Data Discrepancies
CRAs work closely with study staff to resolve data inconsistencies and ensure correct data reporting.
CRAs work hard to ensure that subject safety is monitored and promptly report adverse events.
CRAs maintain detailed and well-structured study documentation.
Assisting in Trial Material Preparation and Compliance
CRAs also get involved in the preparation of study-related materials and contribute to the development of study protocols and other study documents.
They ensure compliance with study timelines and milestones, working to support regulatory inspections and audits.
What are the Required Qualifications of a CRA?
Biotech, pharma, and medical device companies planning to hire freelance CRAs should ensure that candidates meet these requirements:
- A bachelor’s degree in a relevant scientific field such as life sciences, pharmacy, or nursing.
- Significant experience (at least 6 or 7 years) working as a CRA or in a related clinical research role.
- Solid knowledge of ICH-GCP guidelines and regulatory requirements.
- Good communication skills, enabling effective collaboration with various involved parties.
- Attention to detail and the ability to work independently and proactively.
Cities and Therapeutic Areas Covered in Slovakia
With a global population of nearly 5.5 million people, Slovakia is an attractive destination to conduct clinical trials.
The CRAs provided by Sofpromed in Slovakia operate in the following cities, among others:
- Bratislava
- Kosice
- Presov
- Zilina
- Banska Bystrica
On the other hand, our CRAs are experienced in the following therapeutic areas, among others:
- Oncology
- Cardiovascular
- Metabolic
- CNS
- Dermatology
- Infectious diseases
- Respiratory
Our CRAs can work on phase I-III clinical trials as well as on post-marketing studies.
Hire a Freelance CRA in Slovakia
Clinical trial sponsors can hire a highly qualified, English-speaking, freelance CRA in Slovakia by signing an agreement with Sofpromed, which offers freelance CRAs in this country starting at an hourly rate of 75 €, depending on years of experience.
Hiring a CRA through Sofpromed is simple and convenient, with no hidden costs other than the fixed hourly rate.
The freelance contracting model allows for maximum flexibility, with senior profiles that can be hired for short or long periods, full or part time, or less depending on the sponsor’s needs.
Using freelance CRAs eliminates the administrative burden and overhead costs associated with hiring in-house employees.
Conclusion
A CRA plays a critical role in the successful management of clinical trials.
They monitor and coordinate clinical studies, ensuring adherence to protocols, regulatory requirements and GCP guidelines.
CRAs collaborate with investigators, study coordinators and site staff to accelerate the execution of clinical trials and advance the development of innovative therapies.
Biotech, pharma, and medical device companies can hire a freelance CRA in Slovakia by formalizing a straightforward contract with Sofpromed.
