Clinical Research Associate

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Job Summary:We are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The CRA will play a critical role in ensuring the successful planning, execution, and monitoring of clinical trials. The ideal candidate will have a strong understanding of clinical trial processes, regulatory requirements, and excellent communication and organizational skills.Key Responsibilities:Site Management:Conduct site initiation, routine monitoring, and close-out visits to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements. Build and maintain strong relationships with investigative sites, investigators, and study coordinators.Clinical Trial Monitoring:Perform routine monitoring visits to assess site performance, data integrity, and regulatory compliance. Ensure timely resolution of data queries and issues identified during monitoring visits.Protocol Compliance:Ensure that all study activities are conducted in accordance with the approved protocol, SOPs, and applicable regulatory guidelines. Collaborate with investigators to address and resolve protocol-related queries.Regulatory Compliance:Assist in the preparation and submission of regulatory documents to ethics committees and regulatory authorities. Stay informed about changes in regulatory requirements and update study teams accordingly.Data Management:Collaborate with data management teams to ensure accurate and timely data collection and entry.Perform source data verification and data validation activities.Safety Reporting:Monitor and report adverse events in compliance with regulatory requirements and safety reporting procedures. Ensure that safety reports are submitted to relevant authorities and stakeholders.Training and Support:Provide training and support to site staff on study protocols, data collection, and regulatory compliance. Act as a resource for investigators and site staff throughout the duration of the study.Requirements:Education: Bachelor's degree in a relevant life sciences field.Experience:Minimum of 3 years of experience as a Clinical Research Associate.Proven track record of successful site management and monitoring in clinical trials.Regulatory Knowledge: Familiarity with regulatory requirements and guidelines governing clinical trials.Please use the below link for job application and quicker response.https://lifelancer.com/jobs/view/43cc295bbf1e054ed5eaa3123a9a3893

29 April 2024
Location: India Trieste Hyderabad
Work type:
Full time
PLEASE! No enquiries from Recruitment Agencies or Headhunters.

Only direct applications will be considered.

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