Job Description:

The Clinical Research Specialist (CRS) is responsible for supporting and overseeing clinical trial activities across Phase I–IV studies, ensuring compliance with study protocols, Valuable Clinical Practice (ICH-GCP), Standard Operating Procedures (SOPs), and applicable regulatory requirements. The CRS collaborates closely with Clinical Operations, Medical Affairs, Clinical Scientists, Investigators, CROs, and study site personnel to ensure subject safety, data integrity, and successful execution of clinical research programs.

Responsibilities:

Clinical Trial Management & Site Oversight:
- Support the planning, initiation, conduct, monitoring, and closeout of clinical studies.
- Coordinate with investigators, study coordinators, CROs, and internal stakeholders to ensure successful study execution.
- Participate in site feasibility assessments, qualification visits, site initiation visits, monitoring visits, and closeout activities.
- Track study progress, enrollment, retention, and site performance metrics.

Clinical Monitoring & Data Quality:




- Review and verify source documentation, case report forms (CRFs/eCRFs), informed consent forms, and study records.
- Ensure accuracy, completeness, and integrity of clinical trial data in compliance with ALCOA principles.
- Monitor protocol compliance and identify protocol deviations, discrepancies, and data quality issues.
- Assist in resolving data queries and implementing corrective and preventive actions (CAPA).

Regulatory & Compliance Activities:
- Ensure studies are conducted in accordance with ICH-GCP guidelines, FDA, EMA, and applicable local regulations.
- Review and maintain essential regulatory documentation and study files.
- Support audit and inspection readiness activities and participate in sponsor and regulatory authority inspections.
- Assist in preparation and review of clinical and regulatory documents.

Safety Monitoring:
- Review adverse events (AEs), serious adverse events (SAEs), concom

📌 Clinical Research Specialist (Vijayawada)
🏢 Katalyst Healthcares & Life Sciences
📍 Vijayawada