Site Quality Assurance Specialist

6 days ago

Shimoga, Karnataka, India beBeeResearch Full time ₹ 18,00,000 - ₹ 22,00,000
Job Overview

The Associate Site Report Specialist plays a pivotal role in ensuring that Site Visit Reports (SVRs) adhere to quality standards and align with the organization's objectives of quality, subject safety, data integrity and regulatory compliance.

This specialist oversees a caseload of SVRs for assigned studies, guaranteeing adherence to the protocol, processes, timelines, SOPs and GCP guidelines.

  • Ensure timely and efficient review of SVRs and their associated attachments.
  • Provide expert guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study.
  • Promote collaboration with project team members to minimize the level of corrections/additions needed on reports by offering insight and training of the SVR annotations.
  • Identify and track project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.

Key Requirements:

  • 4-6 years relevant experience as a Clinical Research Associate.
  • Minimum of 3 to 4 years on-site monitoring experience.
  • Basic therapeutic and protocol knowledge.

Qualifications and Experience:
Required Skills and Qualifications
- 4-6 years of clinical research associate experience.
- 3-4 years of on-site monitoring experience.
- Basic therapeutic and protocol knowledge.

How You'll Make a Difference
As an Associate Site Report Specialist, you will play a key role in ensuring the quality and integrity of site visit reports. Your expertise will help ensure that all aspects of the report meet the required standards, and your ability to communicate effectively with the project team will be invaluable. This is a challenging and rewarding role that requires a strong attention to detail and a commitment to excellence.

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