About ICBio Clinical Research Pvt. Ltd.:Headquartered in Bengaluru, India, ICBio is a full-service Contract Research Organization (CRO) with over 16 years of experience in conducting Bioavailability/Bioequivalence (BA/BE) studies and Phase I–IV clinical trials. We have successfully completed over 1,000 BA/BE studies and approximately 500 clinical trials. Our services are approved by several global regulatory bodies, including ANVISA Brazil, DCGI, CDSCO, MHRA, UAE MOH, GCC, MOH Kazakhstan, and Zambia. Our NABL-accredited central laboratory is fully integrated with LIMS, ensuring high-quality data and compliance.Our Services Include:Bioavailability/Bioequivalence StudiesPhase I–IV Clinical TrialsBioanalytical ServicesRegulatory Affairs and Dossier PreparationPharmacovigilanceClinical Data Management and BiostatisticsMedical Writingjob responsibilitiesManaging the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated.Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities.Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements.Ensure compliance to GLP and safety in Lab, Assessment and training of staff on GLP and SOPs and applicable regulatory guidelines.Implementation of Standard Operating Procedure for the analytical method developed and general procedures. Ensure that all relevant SOP’s are available in work place. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc.Ensure computerized systems used in the studies has been validated as per the regulatory requirement.Review and provide inputs for the documents like protocol, study reports, method validation reports, method SOP’s etc. and finalize the same in co-ordination with other departments. Review of the electronic generated data, raw data and logbooks to ensure validity and accuracy.Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure.Approve the individual sample repeats, ISR and investigation of batch failures.In case of any deviation from the protocol, assess and document the impact on the quality and integrity of the study and take appropriate corrective action when necessary.Ensure regular instruments backup and study related documents are archived properly.
Job Title
Senior Research Associate