Remote Senior Clinical Research Associate (Oncology Experience Required)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company that supports clinical studies across various therapeutic areas, and they are seeking a Senior Clinical Research Associate with oncology experience. The Senior CRA will ensure data reputed company and compliance with regulatory standards while collaborating with site personnel and managing monitoring activities. Responsibilities Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops reputed company plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company reputed company Operating Procedures (SOPs)/processesVerifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject as requiredDemonstrates diligence in protecting the confidentiality of reputed company subject and assesses factors that might reputed company subject safety and clinical data reputed company at an investigator site such as protocol deviation and violations and pharmacovigilance issuesPer the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different reputed company, (e.g., both on site and remote) where allowed by country regulationsConducts reputed company document review and verification of appropriate site reputed company documents and medical records. Verifies required clinical data entered in the Case Report reputed company (CRF) is accurate and completeManages reporting of protocol deviations and appropriate follow upApplies query reputed company techniques remotely and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelinesMay reputed company Investigational Product (IP) inventory, reconciliation and reviews storage and reputed companyVerifies the IP has been reputed company and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information reputed company to IPApplies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returnedManages reporting of identified issues and manages follow up to reputed companyDocuments activities reputed company follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMPEnsures reputed company activities are managed by site personnel who are appropriately delegated and trainedEnters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company. For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. (Must be reputed company to quickly adapt to changing priorities to reputed company goals and targets)Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locksReviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer reputed company on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)Conducts follow up for escalated adverse event monitoring (reputed company) report queriesChecks the site and reputed company facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable)Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification reputed company List, IP Accountability Log)Collaborates with reputed company Site Manager who will reputed company as the reputed company reputed company with site personnelPrepares for and attends Investigator Meetings and sponsor face to face meetingsParticipates in global clinical monitoring and project staff meetings (inclusive of reputed company representation, as applicable) and attends clinic Skills Experience in oncology trials and RECIST reputed company is essent .