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Position: Senior Clinical Research Associate

Job Description:

Job Purpose: The role involves site relationship management to ensure sustainable trial execution at the site. The Senior Clinical Research Associate (sCRA) will perform on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials within the country, adhering to ICH/GCP, local regulations, and SOPs. The role includes proactive site performance management, early identification of site needs and issues, and acting as the single point of contact for all site-related activities.

Key Responsibilities:

  • Manage assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
  • Perform Site Initiation Visits, ensuring site personnel are fully trained on all trial-related aspects.
  • Conduct continuous site monitoring activities (onsite and remote), ensuring compliance with protocol, ICH/GCP, global and local regulations.
  • Identify deficiencies in site processes, work closely with sites on risk mitigation and process improvements.
  • Establish strong partnerships with sites to increase patient density and decrease issues.
  • Perform Site Closeout activities, ensuring all follow-up activities and archiving requirements are met.
  • Collaborate with SSO Clinical Project Manager (CPM), CRA Manager, MSL, CRMA, and medical advisor to ensure optimal recruitment, site development, and data quality.
  • Participate in audit organization and inspection readiness activities for monitoring and site-related activities, ensuring implementation of corrective actions within specified timelines.
  • Ensure the site Investigator Folder is up to date and collect essential documents from the site, keeping sTMF(s) updated.

Candidate Profile:

  • Degree in scientific or healthcare discipline.
  • Fluent in both written and spoken English and country language.
  • Minimum 3 years of pharmaceutical industry experience or other relevant experience.
  • Excellent time management and organizational capabilities, with the ability to prioritize and multi-task.
  • Strong decision-making skills and a risk-based mindset.
  • Good knowledge of the drug development process, specifically clinical trial/research.
  • Clinical and therapeutic knowledge, understanding of international standards (GCP/ICH, FDA, EM), and the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance).

Additional Information:

  • Qualification: Degree in scientific or healthcare discipline.
  • Experience: Minimum 3 years.
  • Job ID: REQ-10015289
  • Location: Delhi (Office)
  • Industry Type: Pharma / Healthcare / Clinical research
  • Division: Development
  • Business Unit: Innovative Medicines
  • End Date: 30th August 2024

If you are interested in this opportunity, please apply by the end date.

Application Link

Novartis Hiring Senior Clinical Research Associate

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