WhatsApp Group Join Now
Telegram Group Join Now

ad
AD
Centered Ad Example

Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Job Details

  • Position: Central CRA (Clinical Research Associate) – Registries
  • Location: Hyderabad, India
  • Type: Permanent, Full-Time

Key Responsibilities

  • Feasibility and Start-Up:
    • Participate in site selection and document preparation for Health Authorities and Ethics Committees.
    • Manage site contracts, budgets, and insurance certificates.
    • Ensure compliance with regulatory requirements and customize informed consent forms.
  • Monitoring and Site Management:
    • Conduct remote and onsite visits, including site initiation, monitoring, and close-out activities.
    • Review data for completeness, resolve queries, and ensure adherence to protocols and GCP guidelines.
  • Data and Safety Management:
    • Maintain quality control of study data and monitor safety reporting processes.
    • Address deviations, implement CAPAs, and prepare for audits/inspections.
  • Administration and Reporting:
    • Maintain trackers and databases to follow study progress.
    • Participate in meetings, training, and quality audits.
    • Ensure Trial Master File (TMF) compliance throughout the study lifecycle.
  • Stakeholder Communication:
    • Collaborate with sponsors, investigators, and regulatory bodies.
    • Resolve conflicts and provide timely updates on study progress.

Required Qualifications

  • Education: Degree in a Pharma/Scientific discipline or related Life Sciences.
  • Experience:
    • Minimum 3 years in clinical research, including trial monitoring.
    • Experience with rare diseases, observational studies, or real-world evidence is a plus.
    • Exposure to global projects and international environments.
  • Technical Skills:
    • Strong knowledge of GCP and regulatory requirements.
    • Proficiency in data management, medical terminology, and clinical trial processes.
    • Familiarity with Microsoft Office.
  • Soft Skills:
    • Excellent communication, adaptability, and time management.
    • Strong problem-solving and ethical judgment.
    • Interpersonal skills for stakeholder management.

Application Link

ad
AD

Popup Ad Example
Sticky Buttons
Join WhatsApp Group References Join Telegram