Clinical Research Associate

Company Description

Novaspire Biosciences Private Limited is a healthcare company specializing in Pharmacovigilance, Clinical Research, and Bioavailability/Bioequivalence studies Project Management support. Novaspire is dedicated to enhancing patient safety and promoting public health through innovative solutions for the pharmaceutical and biotechnology industries. Our team of experienced professionals provides a wide range of services, including Pharmacovigilance, Clinical Research Consulting, and Regulatory Affairs Solutions.

Objectives of this role

• Ensuring compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines.
• Conducting regular site visits to monitor trial activities and data collection.
• Reviewing and analysing clinical trial data for accuracy and completeness.
• Developing and maintaining study timelines and budgets.
• Providing training to study staff on study protocols and GCP guidelines.

Your tasks

• Reviewing and approving study-related documents, such as informed consent forms.
• Conducting source data verification and ensuring data quality.
• Managing trial supplies and drug accountability.
• Serving as a liaison between study sites, sponsors and regulatory agencies.  

Required skills and qualifications

• bachelor's/Master's degree in pharmacy.
• At least 1 year of experience in a similar role.
• Knowledge of regulatory requirements and guidelines, such as Good Clinical Practice (GCP) and International Council for Harmonization (ICH).
• Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification.
• Knowledge of clinical trial data management systems and electronic data capture.
• Experience with site selection, initiation, management, and monitoring activities.
• Strong attention to detail and accuracy in data management.

Preferred skills and qualifications

• Understanding of pharmacology and drug development processes.
• Working knowledge of medical terminology and anatomy.
• Excellent project management and leadership skills with attention to detail.
• Ability to work collaboratively with study teams and cross-functional departments