SESeven Consultancy
Clinical Research Associate
Hyderabad ₹5-8 LPA Posted 12 Dec 2025
FULL TIME
Clinical Trials
data integrity
Clinical Research
Site Management
Recruitment
Job Description
- Ensure clinical research studies are conducted in compliance with protocol, SOPs, Good Clinical Practice (GCP) guidelines, and other regulatory requirements.
- Perform site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work and GCP guidelines.
- Review and oversee informed consent documents and procedures.
- Negotiate study budgets with investigators and assist in execution of site contracts.
- Provide site management and monitoring visits for multiple protocols and sites.
- Train site personnel on protocol and study-related procedures, and establish regular communication to manage project expectations.
- Evaluate the quality and integrity of study site practices, ensuring adherence to protocol and regulations.
- Escalate quality issues to Clinical Project Manager or line manager when necessary.
- Ensure accurate data reporting through review of site source documents and medical records.
- Identify protocol deviations and assess risks to subject safety and data integrity.
- Perform investigational product accountability as per protocol and Study Monitoring Plan.