Veeda Clinical Research (Veeda CR) is a leading contract research organization (CRO) headquartered in Ahmedabad, India. Renowned for its commitment to quality and excellence, Veeda CR provides a comprehensive range of clinical research services. With over two decades of expertise, the company supports global pharmaceutical and biotechnology firms in delivering effective and compliant clinical trials, ensuring the highest standards of regulatory adherence.
Role Overview: Clinical Research Associate
Veeda CR is looking for a talented and motivated Clinical Research Associate (CRA) to join its team in Ahmedabad. This position offers a unique opportunity to work on groundbreaking research projects, monitor clinical trials, and contribute to the advancement of healthcare solutions.
Responsibilities in the Role
Off-Site Monitoring
- Conduct off-site visits during different phases of clinical studies, including initial site visits to train and guide site personnel.
- Verify site readiness for the study by ensuring all prerequisites are met per the study protocol.
- Perform routine monitoring visits at regular intervals as outlined in study guidelines.
Communication and Documentation
- Manage Feasibility Assessment Questionnaires (FAQ) and collect necessary information from potential sites.
- Conduct regular follow-ups with site nodal/in-charge personnel.
- Prepare and submit detailed reports for various visits, such as:
- Pre-study Qualification Report
- Site Initiation Visit Report
- Site Monitoring Visit Report
- Site Closeout Visit Report
- Ensure timely submission of reports and updates related to study trials.
Audits and Compliance
- Review study-related documents to maintain compliance with Standard Operating Procedures (SoPs), protocols, and regulatory requirements.
- Train, guide, and mentor the off-site team regarding study protocol and regulatory standards, including Good Clinical Practice (GCP) and Root Cause Analysis.
- Address queries raised by internal and external auditors, ensuring adherence to quality and compliance expectations.
Qualifications Required
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Experience: 3 to 5 years of relevant experience in clinical research.
- Certifications: GCP certification is an added advantage.
Key Skills
- Strong understanding of clinical research processes and regulatory requirements.
- Excellent documentation and reporting skills.
- Proficient in training and mentoring site personnel.
- Effective communication and problem-solving abilities.
- Attention to detail to ensure protocol adherence and compliance.
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