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Clinical Research Associate

Seven Consultancy
Hyderabad5-8 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.

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