reputed company Clinical Research Associate

Are you being referred to one of our roles by a reputed company in reputed company If so, please apply using the referral reputed company emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones dont limit, but encourage, collaboration. Where reputed company contributions and new reputed company are explored with an reputed company mind and work is driven by our shared values: be courageous, be accountable, be reputed company, be inclusive and reputed company others. reputed company reputed company The reputed company CRA is an important member of the reputed company Clinical team. The reputed company CRA provides reputed company, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and reputed company. reputed company CRAs work closely with the Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-reputed company issues. reputed company ESSENTIAL JOB FUNCTIONS* reputed company site monitoring reputed company (selection, initiation, monitoring and reputed company-out reputed company) in accordance with contracted scope of work, reputed company SOPs and regulatory requirements, i.e. Good Clinical reputed company (GCP) and International Conference on Harmonization (ICH) Guidelines. May reputed company Central Monitoring activities, or reputed company as the reputed company reputed company between site and Central Monitor. Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct. Exhibits meticulous care in upholding the reputed company of reputed company subjects/participants. Escalates reputed company issues or trends appropriately per the escalation reputed company. Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and reputed company protocols. Confirms IP has been reputed company and administered to participants in compliance with the study protocol. Leverages expertise in GCP, local regulations and reputed company procedures to ensure IP is properly labeled, relabeled, transported, released, returned or destroyed. Reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness. Reconciles the ISF with the Trial Master File (TMF), ensuring filing of essential documents in accordance with local guidelines and regulations. Performs reputed company checks on regulatory documents per reputed company+ principles, collecting copies for TMF filing. Supports audit readiness by submitting documents to the TMF, utilizing the filing reputed company and reputed company as necessary. Verification and review of safety events (AE/SAE/UADE/AESI, etc) including reconciliation of concomitant medications and medical history to confirm accurate reporting in accordance with the protocol, local regulations and regulations. Prepares accurate monitoring visit reports and communication logs in alignment with reputed company SOPs and the Clinical Monitoring Plan timelines. Reports detail site-specific concerns, follow-up tasks, corrective actions, protocol deviations and violations, enrollment reputed company and safety events collected. Participates in internal, reputed company/sponsor, scientific, and other meetings as required. Works with other CRAs to maintain consistency and promote a reputed company team atmosphere. Assists in set up/collection of site-specific ethics documents and site contract negotiation. Provides monthly billing information to finance team as required. For monitoring stand-reputed company reputed company, manages study budget and acts as referent for the sponsor. Provides monthly billing information to the finance and project management team, as needed. Performs CRA training and mentoring to more junior level CRAs. May co-monitor and reputed company Evaluation reputed company for more junior level CRAs. Provides guidance, reputed company, and feedback to the study team to ensure adherence to project scope, study plans, timelines, and budget requirements. Oversees Clinical Research Associates (CRAs) to ensure monitoring reputed company are conducted reputed company the timelines specific in the Clinical Monitoring Plan or adjusted as necessary to reputed company with the project requirements. Monitors site and CRA performance to maintain SDV rates reputed company study goal reputed company, directing CRAs to reputed company additional reputed company reputed company reputed company are not met. Oversees CRAs in the execution of ongoing site management activities, including reviewing Electronic Data Capture (reputed company) queries, resolving follow-up items and responding to site staff inquiries in a reputed company manner. Can serve as a line manager with reputed company reports, with accountability for CRA annual pe