Clinical Quality Monitor

2-5 years

Not Disclosed

Ahmedabad

1 June 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Description: Clinical Quality Monitor

Company: Veeda Clinical Research Limited
Location: Ahmedabad, India
Position: Clinical Quality Monitor
Experience: 2-5 Years
Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm

About Veeda Clinical Research Limited

Veeda Clinical Research Limited is a leading global clinical research organization headquartered in Ahmedabad, India. We are dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries. Our mission is to deliver excellence in clinical trials with a commitment to scientific integrity, regulatory compliance, and the highest ethical standards.

Job Summary

As a Clinical Quality Monitor at Veeda Clinical Research Limited, you will be responsible for ensuring that clinical trials are conducted in compliance with applicable regulations, guidelines, and company standards. Your role will involve monitoring clinical trial sites, reviewing clinical data, and ensuring that clinical practices adhere to the highest quality standards.

Key Responsibilities

Site Monitoring and Auditing:
- Conduct routine monitoring visits to clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Perform site audits to evaluate the quality and integrity of clinical trial conduct and data.
Quality Assurance:
- Review and verify clinical trial documentation, including informed consent forms, case report forms, and source documents, to ensure accuracy and completeness.
- Ensure proper documentation and resolution of any deviations, non-compliances, or discrepancies identified during monitoring visits.
Data Review and Analysis:
- Analyze clinical trial data for accuracy, consistency, and completeness.
- Collaborate with data management teams to resolve data queries and discrepancies.
Training and Support:
- Provide training and guidance to clinical site staff on GCP, study protocols, and standard operating procedures (SOPs).
- Support site staff in resolving any issues or challenges related to study conduct and quality.
Reporting and Documentation:
- Prepare detailed monitoring visit reports and audit reports.
- Maintain comprehensive and accurate records of monitoring activities and findings.
Collaboration and Communication:
- Collaborate with clinical project managers, investigators, and other stakeholders to ensure smooth conduct of clinical trials.
- Communicate effectively with site staff, study sponsors, and regulatory authorities as needed.

Qualifications and Skills

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 research, with a focus on clinical quality monitoring or clinical trial coordination.
Technical Skills:
- Strong understanding of clinical trial processes, GCP, and regulatory requirements.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Analytical Skills:
- Excellent analytical and problem-solving skills with attention to detail.
- Ability to review and interpret clinical data and identify discrepancies.
Interpersonal Skills:
- Strong communication and interpersonal skills to effectively interact with site staff, investigators, and team members.
- Ability to work independently and as part of a multidisciplinary team.
Organizational Skills:
- Excellent organizational and time-management skills.
- Ability to manage multiple tasks and prioritize effectively.

What We Offer

Competitive salary and benefits package.
Opportunities for professional growth and development.
A supportive and collaborative work environment.
The chance to contribute to cutting-edge clinical research.

How to Apply

Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and qualifications to careers@veedacr.com with the subject line "Application for Clinical Quality Monitor."

Join Veeda Clinical Research Limited and be a part of a team that is committed to advancing medical science and improving patient outcomes through high-quality clinical research.

Note: This job description is intended to provide a general overview of the position and may include other responsibilities and qualifications as required by Veeda Clinical Research Limited.

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Clinical Quality Monitor

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Job Description: Clinical Quality Monitor

About Veeda Clinical Research Limited

Job Summary

Key Responsibilities

Qualifications and Skills

What We Offer

How to Apply

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