Job Summary

• Position: Clinical Research Associate 2 (CRA 2)
• Location: Thane, Maharashtra, India
• Job Type: Full-Time
• Application Deadline: 24th December 2024
• Employer: IQVIA, a global leader in clinical research services.

Responsibilities

1. Conduct on-site and remote monitoring visits, ensuring compliance with GCP, ICH, and sponsor requirements.
2. Collaborate with clinical sites to enhance subject recruitment and ensure protocol adherence.
3. Oversee regulatory submissions, approvals, recruitment, case report forms, and data query resolutions.
4. Maintain essential study documentation in TMF and ISF as per regulatory standards.
5. Communicate effectively with sites, providing training and addressing project expectations.
6. Generate detailed reports on site visits, follow-ups, and action plans.
7. Support site financial management in alignment with clinical trial agreements.

Qualifications

• Education: Bachelor’s degree in a scientific or healthcare discipline preferred. Equivalent education/experience may be considered.
• Experience: Minimum 1 year of on-site monitoring experience.
• Skills:
  • Knowledge of GCP/ICH guidelines.
  • Familiarity with clinical research regulatory requirements.
  • Proficient in Microsoft Office tools.
  • Strong organizational, communication, and problem-solving abilities.

About IQVIA

IQVIA is renowned for its contributions to healthcare innovation, clinical trial management, and commercial insights. Joining IQVIA offers exposure to cutting-edge developments in the life sciences industry.

Application Link