Responsibilities Responsible for monitoring Phase-I-IV clinical trials. Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Documentation Practice (GDP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Working independently, developing Monitoring Plan in coordination with the Project Manager and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation. Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested. Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required. Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner. Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report. Tracking and Managing Investigator’s grant, trial budget in coordination with the Project Manager. Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a Project Manager. Assume additional responsibilities as directed by Project Manager (PM). Dependent on level of experience you may assist in training and mentoring less expert CRA's and/or lead CRA's working on global projects. Seniority level Entry level Employment type Full-time #J-18808-Ljbffr Clinical Trial Network, LLC.
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