Clinical Research Associate

Seven Consultancy

2 - 5 years

4 - 7 Lacs

hyderabad telangana india

Posted:12 hours ago| Platform: Foundit logo

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Skills Required

standard operating procedures (sops) clinical research recruitment site management clinical trials data integrity

Work Mode

On-site

Job Type

Full Time

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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