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.