Clinical Research Coordinator

Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionJob description:The Immuno-Oncology (IO) Clinical Project Coordinator is a member of the Immuno-Oncology Global Medicines (GMD) group.The IO Project Coordinator will work with a cross-functional team of experts to develop and maintain a web portal, database and robust process for the Toxicity Management Guidelines (TMGs) used across the IO Program.The individual in this role will liaise with IO project teams, the IO Lead Safety Physician, IT, external vendors, colleagues from the Site Management & Monitoring (SM&M) organization, and external investigational sites across the world. This role could be broadened in future to include other IO processes.Responsibilities:Work with IT to develop the website, associated applications and training materials that will be used by IO project teams and external investigatorsMaintain the databaseAdd/remove investigator sites and maintain information on who has access to web portalGrant accesses to the portal based on IRB and Regulatory approval datesDevelop communication plan and ensure it is followedWork collaboratively with key stakeholders such as IT, SM&M, and external vendors to identify a robust process for communicating changes in the databaseLink with the IO Lead Safety Physician and other key stakeholders to ensure proper exchange of information and a common understanding of expectationsDevelop and maintain the process, perform gap analyses and propose process improvementsRequirements:Education Undergraduate degreeGeneral knowledge of the drug development processDatabase/process management experience in complex, multi-disciplinary environmentExperience of working collaboratively in global, multi-cultural teamsProven ability to transition between roles effectively and learn rapidly in a new environmentExperience of building processes and conducting gap analysesExperience in using databases and process maintenanceExperience of using CTMS databases (eg IMPACT)Additional InformationAll your information will be kept confidential according to EEO guidelines.