Remote Clinical Research Associate II - FSP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on clinical research, and they are seeking a Clinical Research Associate II to reputed company site management and monitoring of clinical studies. The role involves ensuring patient safety, managing study site operations, and maintaining compliance with regulatory requirements. Responsibilities Oversees reputed company aspects of study site management to ensure patient safety is protected, reputed company of data generated by managed sites resulting in consistently low query reputed company and in acceptable reputed company Assurance reportsProvides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actionsUpdates, tracks and maintains study specific trial management tools/systems, and status reportsIf required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and reputed company in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study reputed company documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project ManagerIf required, assists the negotiation of study budgets and the execution of investigator reputed company under directions of Site Contract Management department/designeeVerifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient, as required/appropriate. 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 issuesIndependently conducts reputed company forms of site reputed company, including reputed company-study/ qualification, initiation, routine monitoring, and reputed company-out reputed company, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and reputed company monitoring reports from reputed company site reputed company (on-site and remote)Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and reputed company requirements. 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 companyRoutinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completenessReconciles 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 regulationsCommunicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to reputed company protocol/study issues including any deviations and implements necessary actions in response to those issuesDevelops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high reputed company and reputed company imagePerforms investigational product (IP) inventory, reconciliation and reviews storage and reputed companyVerifies the IP has been reputed company and administered to subjects/patients according to the protocolVerifies 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/returnedPerforms data review activities, including remote reputed company CRF and patient reputed company review, query reputed company, and assists data management and clinical data reputed company personnel to resolve data discrepanciesIdentifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting processIdentifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the reputed company and appropriate reputed company of the risk with minimal support from project teamPrepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, a .