Clinical Research Associate

4 - 8 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

You will be responsible for monitoring patient data and study-related information at clinical study sites to ensure adherence to research protocols, regulatory requirements, and good clinical practices. Your role will involve providing input into data validation plans and ensuring timely and accurate monitoring of patient data. You may also be required to monitor study sites and audit facility selection. Key Responsibilities: - Act as the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis" expectations on milestones and deliverables with a true ownership mindset - Manage assigned study sites, conduct phase I-IV protocols according to the Monitoring Plan and Novartis procedures - Perform Site Initiation Visit, ensure site personnel are fully trained on all trial-related aspects, and provide continuous training for amendments and new site personnel - Conduct continuous site monitoring activities (onsite and remote) and implement site management activities to ensure compliance with protocols and regulations - Identify deficiencies in site processes, work on risk mitigation, and collaborate with sites on process improvements - Promote a compliance culture advocating adherence to high standards and ethical integrity to ensure human subject protection and reliability of trial results - Collaborate with internal stakeholders to manage data query resolution process and ensure timely and accurate data entry Qualifications Required: - Degree in scientific or healthcare discipline (or, for United States: 4-year degree plus relevant, related healthcare experience) - Fluent in both written and spoken English and country language Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities served. If you require a reasonable accommodation for any part of the recruitment process, please contact [email protected] and include the job requisition number in your message.,

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