Sun Pharma Hiring Clinical Research Associate

Responsibilities

• Clinical Trials Management:
  • Ensure clinical trials are conducted per protocol, local regulatory requirements, ICH GCP, and ethical standards.
  • Act as the primary communication point between Sun Pharma and clinical trial sites regarding site management activities.
  • Facilitate regulatory submissions and ensure timely IRB/IEC dossier preparation and submission.
  • Perform site feasibility assessments and maintain the site database with updated feasibility results.
  • Plan and conduct Site Selection Visits (SSVs) and ensure follow-up actions are completed.
• Document and Budget Management:
  • Review translated study documents.
  • Negotiate study budgets with sites and ensure timely execution of Clinical Trial Agreements (CTAs).
  • Process site invoices and track site-related payments.
  • Ensure accurate and timely updates of site-related details in essential systems.
• Site and Study Oversight:
  • Perform Site Initiation Visits (SIVs) and provide training to the study team.
  • Plan and conduct Onsite Monitoring Visits as per the Site Monitoring Plan and follow up on action items.
  • Provide periodic updates on study progress, risks, and quality to RTLs and management.
  • Collaborate with cross-functional units to ensure efficient study conduct.
  • Manage IMP supplies and coordinate with RTLs & Trial Operation Managers for supply orders.
  • Track and manage study protocol-required supplies at the sites.
  • Plan and track recruitment/retention strategies and communicate recruitment risks to RTLs.
• Compliance and Quality Assurance:
  • Ensure compliance with onsite visits, action items, and SAE reporting requirements.
  • Prepare sites for audits, inspections, and quality/oversight visits.
  • File all essential documents in ITF and TMF.
  • Perform site closeout visits and ensure follow-up as per defined processes.
  • Communicate/escalate compliance issues and trends to RTLs.
  • Maintain healthy relations and effective communication with the site team.
  • Plan and manage Investigator meetings.
• Out-sourced Trials:
  • Conduct accompanied visits with CRO monitors to ensure quality, PI oversight, and site management.

Application Link