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Clinical Quality Monitor

2-5 years
Not Disclosed
1 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Sc / M.Sc/ B.Pharm / M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Quality Monitor

Experience Required: 2–5 Years
Education Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm
Location: Ahmedabad


Job Description

We are seeking a detail-oriented and experienced Clinical Quality Monitor to join our team in Ahmedabad. The ideal candidate will ensure the highest quality standards in clinical trials by monitoring processes, documentation, and compliance with regulatory guidelines.


Key Responsibilities

  • Quality Monitoring: Oversee clinical trial activities to ensure compliance with Good Clinical Practices (GCP), standard operating procedures (SOPs), and applicable regulatory requirements.

  • Site Audits: Conduct regular on-site and remote audits of clinical trial sites to verify adherence to protocols and documentation standards.

  • Training and Guidance: Train clinical staff on quality standards and provide ongoing guidance to improve processes.

  • Document Review: Review and validate trial documents, including case report forms, informed consent forms, and other regulatory submissions.

  • Risk Assessment: Identify risks and deviations in clinical trial operations and recommend corrective and preventive actions.

  • Reporting: Prepare detailed monitoring reports and share findings with clinical and regulatory teams for necessary follow-up.

  • Collaboration: Work closely with clinical research coordinators, investigators, and sponsors to ensure seamless trial execution.

  • Continuous Improvement: Stay updated with industry trends, guidelines, and best practices to enhance clinical quality monitoring processes.


Candidate Requirements

  • Educational Background: Bachelor’s or Master’s degree in Science (B.Sc/M.Sc) or Pharmacy (B.Pharm/M.Pharm).

  • Experience: 2–5 years of experience in clinical trial monitoring, quality assurance, or a related field.

  • Technical Skills:

    • Strong understanding of clinical research processes and GCP guidelines.

    • Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.

  • Soft Skills:

    • Excellent attention to detail and problem-solving skills.

    • Strong verbal and written communication abilities.

    • Ability to work independently and as part of a team.

  • Travel: Willingness to travel to clinical trial sites as required.


Why Join Us?

  • Opportunity to work with a leading organization in clinical research.

  • A collaborative and growth-oriented work environment.

  • Competitive compensation package and benefits.

  • Hands-on experience in cutting-edge clinical research projects.

If you have a passion for maintaining the highest quality standards in clinical trials and are eager to contribute to the advancement of healthcare, apply today and join our team in Ahmedabad!