Clinical Research Associate

Clinical Research Associate

Job Summary:

We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. The role involves conducting bioequivalence studies to assess the equivalence of generic drugs to their reference counterparts. The ideal candidate will have a strong background in pharmacokinetics, pharmacology, and clinical research, with a focus on ensuring compliance with regulatory guidelines and maintaining high scientific standards.

Objectives of this role

• Designing bioequivalence studies based on regulatory requirements and scientific principles
• Developing study protocols and ensuring they meet all necessary criteria.
• Ensuring compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines
• Evaluate risks of BE study, develop mitigation strategies, and monitor their implementation
• Identify potential issues early in the study and collaborate with the study team to implement solutions
• 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
• Managing or overseeing the execution of BE studies
• Collaborating with cross-functional teams including clinical operations, data management, and biostatistics.
• Ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulatory guidelines (FDA, EMA, TGA, Health Canada, etc.)
• Participating in audits and inspections related to bioequivalence studies.
• 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.
• Literature review from published studies/ references on bioavailability and bioequivalence of drug product
• Review of In-vitro data for BE confirmation
• Addressing Regulatory queries

Qualifications and Skills Required

• Educational Background

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Master's or PhD in Pharmacology, Pharmaceutical Sciences, or related field.

• Experience

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• Minimum 4 years of study design and on-site monitoring experience of bioequivalence studies
• Experience with regulatory requirements, GCP, and clinical trial management is highly desirable. Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
• A demonstrated working knowledge of ICH/GCP Guidelines.

• Skills

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• Strong attention to detail and the ability to track and manage large amounts of data.
• Excellent organizational and time-management skills.
• Strong communication skills for liaising with site staff, investigators, and sponsors.
• Strong knowledge of pharmacokinetics, biostatistics, and clinical trial methodologies.
• Problem-solving and analytical abilities to manage unexpected challenges during a study.
• Ability to travel frequently for site visits, if required.
• Knowledge of software tools used for pharmacokinetic analysis.