Clinical Research Associate RIANSHI DEVELOPERS PRIVATE LIMITED

About RIANSHI DEVELOPERS PRIVATE LIMITED

Job Description

A Clinical Research Associate (CRA) plays a crucial role in clinical trials, ensuring they are conducted ethically and in accordance with regulations. CRAs monitor trials, manage data, and ensure participant safety. They act as a key liaison between sponsors, research sites, and other stakeholders. 

    Key Responsibilities:

• Monitoring Clinical Trials: CRAs conduct site visits to verify that trials are following the study protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines.   

 

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• Data Management: They oversee the collection, documentation, and entry of data into electronic data capture (EDC) systems, ensuring accuracy and completeness.   

 

• Participant Safety: CRAs are responsible for ensuring the safety and well-being of trial participants.   

 

• Regulatory Compliance: They ensure that trials adhere to all relevant regulations and guidelines, including those from regulatory bodies like the FDA.   

 

• Communication and Liaison: CRAs serve as a primary point of contact between the sponsor, investigators, and other stakeholders, facilitating communication and resolving issues.   

 

• Site Management: They may be involved in identifying and qualifying potential investigators, setting up research sites, and managing study supplies.   

 

• Report Preparation: CRAs contribute to the preparation of reports, including interim monitoring reports, and may be involved in the development of publications based on trial data.   

  In essence, a CRA is responsible for the operational aspects of clinical trials, ensuring data integrity, participant safety, and regulatory compliance