ZENOVEL

Zenovel helps pharma and biotech companies advance trials and bring products to market with compliant, efficient processes. The company delivers end-to-end GCP, GMP, regulatory affairs, clinical…

AI-powered ServicesClinical ResearchDrug DevelopmentGCPGMPPharmaceuticalQuality ManagementRegulatory Affairszenovel.com

ZENOVEL

Zenovel helps pharma and biotech companies advance trials and bring products to market with compliant, efficient processes. The company delivers end-to-end GCP, GMP, regulatory affairs, clinical…

AI-powered ServicesClinical ResearchDrug DevelopmentGCPGMPPharmaceuticalQuality ManagementRegulatory Affairszenovel.com

HQAhmedabad, IN

Team Size48

Open Jobs1

Total Funding-

Latest FundraiseUnknown

Join the Team

Clinical Research Associate

On-SiteAhmedabad, Gujarat, IN

On-Site • Ahmedabad, Gujarat, IN

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Company Description

Zenovel specializes in delivering high-impact solutions across Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Regulatory Affairs in the pharmaceutical and biotech industries. With over 20 years of global experience, we assist companies in ensuring their trials, facilities, and products meet international regulatory standards efficiently. Our services span a wide range, including clinical development support, manufacturing compliance, and strategic regulatory guidance with expertise across diverse study designs and therapeutic areas. Committed to compliance-driven growth, Zenovel transforms complex regulations into competitive advantages for our partners. Our mission is to enable scalable, secure, and globally compliant solutions.

Role Description

• Take part in monitoring plan meeting

• Overseeing the progress of a BA/BE studies or clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

• Checking documents of CRO internal System audit at specified interval and related documents and CAPA

• Perform on-site/remote monitoring visits i.e initiation, periodic monitoring, close out meetings, Bioanalytical visits and coordinate with project coordinators/project in-charges at different CROs for clinical trials & BA/BE studies.

• Prepare the Monitoring Reports and taking follow up for the corrective actions and preventive actions taken by the site to solve all the observations. In addition, providing them suitable suggestions/recommendations if required.

• Taking part in Audit strategy meeting

• Conducing on-site/remote audit of BE CROs and phase-I facility

• Preparation of Audit report and checklist

• Compilation of the study source documents and submit to QMS for archival

• Training of the new monitors/auditors and guide them for operation

• Update the OneDrive with all soft copy of data

• To perform other responsibility and duties delegated by the director operation and management.