Clinical Research Associate

2 weeks ago

new delhi, India Lifelancer Full time

About the job

Summary

Monitors patient data study-related information related to clinical study sites and clinical trial participation.. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection.

About The Role

Monitors patient data study-related information related to clinical study sites and clinical trial participation.. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. May monitor study sites and audit facility selection.

Key Responsibilities

Your responsibilities include, but are not limited to:

Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on achievement and deliverables with true ownership attitude.

Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.

Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate

Conducts continuous site monitoring activities (onsite and remote). Implements' site management activities to ensure compliance with protocol ICH / GCP, global and local regulation including Health Authorities, Institutional Review Board (IRB) / Ethics Committee (EC), data privacy requirements, global and local processes as applicable. Documentation according to Good Development Practice (GDP) and

Novartis standards.

Promotes a compliance culture advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.

Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements.

Proactively collaborates with the Site Study Operations (SSO) Clinical Project Managers (CPM) and CRA Managers as well as Medical Science Liaisons, Clinical Research Medical Advisors (CRMA) and medical advisors to ensure optimal recruitment, site development and data quality.

Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines

Commitment to Diversity Inclusion: :

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Essential Requirements:

Degree in scientific or healthcare discipline

2 years pharmaceutical industry experience or other relevant experience

Central/in-house monitoring or field monitoring experience

Knowledge of international standards (GCP/ICH, Food Drug Administration (FDA), European Medicines Agency (EMA)

Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH Protocol Compliance)

Please use the below link for job application and quicker response.

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