As part of the clinical research process, a Clinical Research Associate (CRA) plays a vital role in ensuring the successful implementation and execution of clinical trials.
In this article, we will explore the tasks and responsibilities of a CRA, and how clinical trial sponsors can benefit from hiring these profiles working as freelancers.
In this article you will learn about:
- $The Role of Clinical Research Associates (CRAs)
- $Advantages of Working with Freelance CRAs
- $Services of Our CRAs in Georgia
- $In Which Cities of Georgia Do Our CRAs Operate?
- $What Types of Clinical Studies Do Our CRAs Manage in Georgia?
- $What Therapeutic Areas Are Covered by Our CRAs in Georgia?
- $How Much Does a Freelance CRA Cost in Georgia?
- $How Are Sofpromed’s CRAs Contracted in Georgia?
In addition, we will explain the services, cities of operation, and hourly rates of the freelance CRAs offered by Sofpromed in Georgia.
The Role of Clinical Research Associates (CRAs)
A Clinical Research Associate (CRA) is responsible for the oversight and management of clinical trials.
They work closely with study sites, investigators, and other stakeholders to ensure that the study is conducted in compliance with regulatory requirements and industry standards.
The CRA acts as the main point of contact between the study site and the sponsor, facilitating effective communication and coordination throughout the trial.
Advantages of Working with Freelance CRAs
Working with freelance CRAs provides the following advantages:
Solid Experience
Freelance CRAs have many years of experience managing clinical trials (frequently 10 years or more).
They are senior profiles who work independently, having very strong expertise in particular therapeutic areas (e.g., Oncology).
Full Flexibility
Freelance CRAs are hired on a per-project basis.
This means they can be contracted for a specific period of need, for example 3 months, 6 months, one year, or more, as required.
Their monthly hours of dedication can also be adjusted (e.g., part time, full time, or a specific number of hours per month).
Simple Contract Without Overheads
Freelance CRAs are hired through a very simple contract.
This avoids administrative burden, contracting overheads, and social insurance costs.
Transparent Billing
Freelance CRA services are normally charged in a monthly basis and the client pays for the actual hours worked each month (with a fixed and transparent hourly rate).
Services of Our CRAs in Georgia
Sofpromed provides highly qualified senior CRAs in Georgia, who perform the following tasks:
- Clinical Trial Approvals and Regulatory Compliance
Thanks to their wide experience, senior CRAs can prepare and submit clinical trial applications to both regulatory authorities and ethics committees.
In the case of Georgia, the CRAs provided by Sofpromed can take care of the whole initial study submission process until obtaining all the required study authorizations.
CRAs are also responsible for ensuring regulatory compliance throughout the clinical trial, and they collaborate with regulatory affairs teams to ensure adherence to all applicable laws and regulations.
- Contracting with Georgian Clinical Sites
Clinical trial sponsors must sign a contract with each hospital or clinic participating in the study.
In Georgia, the CRAs supplied by Sofpromed are experienced in negotiating and signing contracts with clinical sites, in coordination with the sponsor.
- Selection and Initiation of Study Sites
One of the primary responsibilities of a CRA is the selection and initiation of study sites.
This involves identifying potential sites for the clinical trial, evaluating their suitability, and initiating the necessary processes for site activation.
The CRA ensures that the sites have the required infrastructure, resources, and capabilities to conduct the study effectively.
- Monitoring and Compliance
Monitoring the conduct of the study is a critical task for a CRA.
They ensure that the site adheres to the study protocol, Good Clinical Practice (GCP) guidelines, and relevant local regulations.
This includes conducting regular monitoring visits, both remotely and on-site, to assess site performance, review study documentation, and verify data accuracy.
The CRA also identifies and resolves any study-related issues or deviations from the protocol in a timely manner.
- Data Management and Quality Assurance
Data management is an essential aspect of clinical research, and CRAs play a key role in ensuring the accuracy and integrity of study data.
They collaborate with data management teams to ensure proper collection, verification, and documentation of data at study sites.
CRAs also perform remote data checks and ensure that data entry and query resolution are conducted within specified timelines.
- Training and Support
CRAs provide training, support, and guidance to investigators and site staff on study-related matters.
They ensure that site personnel are well-informed about the study protocol, procedures, and regulatory requirements.
CRAs also facilitate the implementation of risk-based quality management principles, which involve proactively identifying and addressing potential risks to patient safety and data integrity.
- Patient Recruitment Support
Successful recruitment of study participants is crucial for the timely completion of clinical trials.
CRAs work closely with study sites to develop recruitment plans and strategies.
They monitor enrollment progress, identify recruitment barriers, and implement mitigation plans to ensure that sites meet enrollment milestones.
CRAs also document recruitment challenges and share best practices to optimize participant recruitment.
- Documentation and Reporting
Accurate and timely documentation is essential in clinical research.
CRAs prepare and finalize monitoring visit reports, ensuring that they adhere to the Clinical Monitoring Plan and study-specific requirements.
They provide feedback to principal investigators and study sites, addressing any findings or recommendations.
CRAs also ensure the timely collection and uploading of essential documents into the electronic Trial Master File (eTMF), following the guidelines of ICH-GCP and relevant local regulations.
In Which Cities of Georgia Do Our CRAs Operate?
The CRAs facilitated by Sofpromed operate in the following Georgian cities, among others:
- Tbilisi
- Batumi
- Kutaisi
- Rustavi
- Sukhumi
What Types of Clinical Studies Do Our CRAs Manage in Georgia?
Our CRAs in Georgia manage phase I-III clinical trials as well as post-marketing studies, either with drugs or medical devices.
What Therapeutic Areas Are Covered by Our CRAs in Georgia?
The CRAs supplied by Sofpromed are experienced in the following therapeutic areas, among others:
- Oncology
- Cardiovascular
- Metabolic
- CNS
- Dermatology
- Infectious diseases
- Respiratory
How Much Does a Freelance CRA Cost in Georgia?
The CRAs provided by Sofpromed can be hired at a fixed all-inclusive rate starting at 75 €/hour, depending on the level of experience.
How Are Sofpromed’s CRAs Contracted in Georgia?
Biotech, pharma, and medical device companies can easily hire the CRAs provided by Sofpromed in Georgia.
The model consists of a straightforward contract between the client and Sofpromed.
Sofpromed will issue invoices to the client, usually on a monthly basis, just charging the actual hours dedicated by the CRA each month.
Conclusion
CRAs are at the forefront of clinical research, ensuring the successful execution of clinical trials and the delivery of high-quality data.
Hiring freelance CRAs is beneficial because of their solid experience, contract flexibility and simplicity, and a transparent billing model.
With Sofpromed, clinical trial sponsors can easily hire CRAs in Georgia covering most therapeutic areas at an hourly rate starting at 75 €.
