Clinical Research Quality Assurance Specialist

7 days ago

Jaipur, Rajasthan, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title

We are seeking a highly skilled Quality and Compliance Specialist to join our team.

The ideal candidate will have a strong background in clinical research and quality assurance, with experience in monitoring and auditing clinical trials. The successful applicant will be responsible for ensuring the highest standards of quality and compliance across all aspects of our business.

  • Monitor and audit clinical trials to ensure compliance with regulatory requirements and company policies.
  • Conduct site visits to evaluate the performance of clinical research sites and provide guidance on improving quality and compliance.
  • Analyze data from audits and inspections to identify trends and areas for improvement.
  • Develop and implement corrective action plans to address any quality or compliance issues identified during audits and inspections.

Key Responsibilities:

  • Perform routine and non-routine monitoring evaluation visits (MEVs) and/or sign-off visits (SOVs) as assigned.
  • Conduct root cause analysis of quality signals and develop action plans to implement process and efficiency improvements.
  • Identify training needs for CRAs based on aggregated oversight data to meet quality and efficiency standards.
  • Assist in reviewing clinical monitoring SOPs, tools, or templates related to monitoring oversight.

Qualifications and Skills

  • Bachelor's degree in biological science or healthcare-related field required.
  • Minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech, or large pharmaceutical company.
  • Additional experience as a CRA Line Manager, Project Manager, Clinical Team Manager, or Quality Control role preferred.
  • Strong analytical and problem-solving skills, with ability to work independently within a matrixed environment.
  • Excellent communication and interpersonal skills, with ability to collaborate effectively with cross-functional teams.

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