Clinical Research Associate Orbit Pharmaceuticals

2.0 - 4.0 years

0 - 0 Lacs

ahmedabad

Work from Office

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

Posted 6 hours ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.