As part of the drug or medical device development process, a Clinical Research Associate (CRA) plays a central role in guaranteeing the effective implementation and execution of clinical trials.
In this article you will learn about:
- $What Is the Role of Clinical Research Associates (CRAs)?
- $Benefits of Using Freelance CRAs
- $Capabilities of Our CRAs in Greece
- $Where Do Our Greek CRAs Operate?
- $What Clinical Studies Do Our CRAs Manage in Greece?
- $What Therapeutic Areas Are Covered by Our CRAs in Greece?
- $What Is the Hourly Rate of a Freelance CRA in Greece?
- $How Are Sofpromed’s CRAs Hired in Greece?
In this article, we will explain the tasks and responsibilities of a CRA, and how biotech, pharma, and medical device companies can benefit from hiring these professionals working as freelancers.
In addition, we will mention the services, cities of operation, and hourly costs of the freelance CRAs offered by Sofpromed in Greece.
What Is the Role of Clinical Research Associates (CRAs)?
A Clinical Research Associate (CRA) is responsible for the supervision and management of clinical trials.
They work closely with hospitals and clinics, investigators, and other collaborators to assure that the study is run according to 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.
Benefits of Using Freelance CRAs
Using freelance CRAs offers the following benefits:
Freelance CRAs have several years of experience handling clinical studies (often 10 years at least).
They are senior, highly specialized professionals who work independently, having very robust expertise in specific therapeutic areas (e.g., Oncology).
Freelance CRAs are contracted on a per-study basis.
This means they may be hired for a definite period, for example 3 months, 6 months, one year, or more, as needed.
Their monthly workload can also be adjusted as required (e.g., part time, full time, or a specific number of hours per month).
Reduced Administrative Burden
Freelance CRAs are hired through a very simple agreement document.
This avoids administrative burden, hiring process overheads, and social insurance costs.
Freelance CRA services are generally invoiced on a monthly basis and the customer pays for the real hours dedicated each month (with a fixed and clear hourly price).
Capabilities of Our CRAs in Greece
Sofpromed offers highly qualified senior CRAs in Greece, who perform the following tasks:
- Clinical Trial Authorizations and Regulatory Compliance
Senior CRAs can prepare and submit clinical trial applications to both regulatory authorities and ethics committees, which includes collecting, preparing, reviewing, and tracking documents for the application process.
In the case of Greece, the CRAs provided by Sofpromed can take care of the whole initial study submission process until obtaining all the required trial approvals.
Our CRAs can be accountable for study startup and regulatory maintenance during the entire study.
- Contracting with Greek Hospitals and Clinics
Clinical study sponsors need to formalize a clinical trial agreement with each hospital or clinic participating in the study.
In Greece, the CRAs supplied by Sofpromed are experienced in negotiating and signing contracts with clinical sites, in coordination with the sponsor.
- Selection and Activation of Clinical Trial Sites
One of the main responsibilities of a CRA is the selection and initiation of study sites.
This involves identifying potential sites for the clinical trial, assessing their suitability, and completing the necessary processes for site activation.
The CRA ensures that the sites have the required facilities, resources, and capabilities to run the study effectively.
- Monitoring and Compliance
Monitoring the activities and data of the clinical study is an essential task for a CRA.
They certify that hospitals adhere to the study protocol, Good Clinical Practice (GCP) guidelines, and relevant local laws.
This includes performing monitoring visits, both remotely and on-site, to evaluate site performance, review study documentation, and verify data accuracy.
The CRA also detects and solves 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 exactness and integrity of study data.
They cooperate with data management teams to guarantee appropriate 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 researchers and site personnel on study-related matters.
They ensure that site staff are well-informed about the study protocol, procedures, and regulatory requirements.
In addition, CRAs proactively identify and address potential risks to patient safety and data integrity.
- Patient Enrollment Support
Effective enrollment of patients is crucial for the timely completion of clinical trials.
CRAs work closely with hospitals to develop enrollment plans and strategies.
They supervise recruitment progress, identify enrollment difficulties, and implement mitigation plans to ensure that sites meet recruitment goals.
- Reporting and Document Management
CRAs prepare and finalize monitoring visit reports, ensuring that they adhere to the Monitoring Plan and study-specific requirements.
They provide feedback to principal investigators and study sites, addressing any issues or recommendations.
Moreover, CRAs ensure the timely collection and transfer of essential documents into the electronic Trial Master File (eTMF), following the guidelines of ICH-GCP and relevant local regulations.
Where Do Our Greek CRAs Operate?
The CRAs provided by Sofpromed work in the following Greek cities, among others:
What Clinical Studies Do Our CRAs Manage in Greece?
Our CRAs in Greece 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 Greece?
The CRAs supplied by Sofpromed have expertise in the following therapeutic areas, among others:
- Infectious diseases
What Is the Hourly Rate of a Freelance CRA in Greece?
The CRAs offered by Sofpromed can be hired at a fixed all-inclusive hourly rate starting at 75 €, depending on the years of experience.
How Are Sofpromed’s CRAs Hired in Greece?
Biotech, pharma, and medical device companies can easily hire the CRAs provided by Sofpromed in Greece.
The model consists of a simple service agreement between the client and Sofpromed.
Sofpromed will issue invoices to the client, typically every month, only charging the actual hours worked by the CRA during the month (registered in a timesheet).
CRAs ensure the effective execution of clinical trials and the delivery of high-quality data.
Contracting freelance CRA services is advantageous because of their solid knowledge, contract flexibility and simplicity, and straightforward invoicing model.
Through Sofpromed, clinical study sponsors worldwide can conveniently hire CRAs in Greece at an hourly rate starting at 75 €.