Remote Clinical Research Associate - Full-Service

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. The Clinical Research Associate will reputed company site qualification, management activities, and ensure compliance with regulatory standards while supporting clinical study data review and capturing. This role requires collaboration with study site personnel and managing project objectives effectively. Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology reputed company (GPP) 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 serious 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 SOPs/processesVerifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of reputed company subject/patient. Assesses factors that might reputed company subject/patients safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issuesPer the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts reputed company Document Review of appropriate site reputed company documents and medical records. Verifies required clinical data entered in the case report reputed company (CRF) is accurate and complete. Applies 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 timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirementsMay reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been reputed company and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information reputed company to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returnedRoutinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is reputed company of the requirement of archiving essential documents in accordance with local guidelines and regulationsDocuments activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed companyFor assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be reputed company to quickly adapt to changing priorities to reputed company goals / targetsMay reputed company as primary reputed company with study site personnel, or in collaboration with Central Monitoring Associate. Ensures reputed company assigned sites and project-specific site team members are trained and compliant with applicable requirementsPrepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirementsProvides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actionsMaintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For reputed company World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Sit .