Chest Research Foundation Kalyani Nagar, Pune, Maharashtra, India
Feb 11, 2017Full time
Job title - Clinical Research Coordinator & Pharmacist Preferred Background - BPharm with clinical research experience Job Description: Candidate will be expected to perform the following roles for both clinical trials and academic trials projects. For Clinical Trials: Duties and Responsibilities: Pharmacy Responsibilities Drug dispensing, procurement, inventory management. SOP preparation, revision and team trainings Temperature and humidity monitoring and surveillance of all drug storage systems Training clinic patients on inhalation devices and techniques. Keeping accountability of used and unused study medications. Checking drug compliance of subject to particular drug. Receiving and checking the consignments of drugs/IMP’s for its appropriateness with respect to temperature during transport, any breakage etc. Same should be acknowledged to sponsor via email/fax. Communication with Sponsor/CRO for various Study related issues. Maintaining all IMP related logs (dispensing log, randomization log, label log etc.). Storage of drugs as per temperature requirement. Daily Temperature & Humidity recording of Cold Storage Room. Maintaining adequate stock of drugs. Coordinating Clinical trials. To oversee the progress of the study and to ensure that the study conduct and data handling comply with the protocol, GCPs and applicable ethical and regulatory requirements. Co-ordination and management of the clinical trial logistics, communication with sponsor and authorities, visit coordination, sampling, time management and IP accountability. Reporting study updates to the principal investigator or physician responsible for performing the trial. Recruitment and co-ordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issues. Data collection and management, collection of source documents, filling of CRFs, filing and archiving, managing monitoring visits, dealing with queries.