Clinical Research Associate II-武汉

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Key Accountabilities: Study Team Supporting Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines. Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and reputed company clinical trials at investigative sites. Reviews and verifies accuracy of clinical trial data collected, either on site or remotely. Provides regular site status information to team members, trial management, and updates trial management tools. Completes monitoring activity documents as required by SOPs or other contractual obligations. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues. Escalates site and trial reputed company issues per SOPs until identified issues are resolved or closed. Performs essential document site file reconciliation. Performs reputed company document verification and query resolution. Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites. Verifies SAE reporting according to trial specifications and ICH GCP guidelines. Communicates with investigative sites. Updates applicable tracking systems. Ensures reputed company required training is completed and documented. Serves as main observer/assessor of site activities. Facilitates audits and audit resolution. To undertake other reasonably reputed company duties as may be assigned from time to time as appropriate for experience and as required e.g., protocol amendment submissions, Investigator site budget negotiation. Mentors’ junior-level CRAs and serves as a resource for new employees. Serves as main observer of site activities and may have some responsibilities for performance of site. May be assigned additional clinical operations tasks: May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines. May be assigned clinical tasks where advanced negotiating skills are r Apply To This Job