Senior Clinical Research Associate - FSP

Benefits

Additional Information

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Site Start-up and activation Maintain a thorough knowledge of assigned protocols Supports activities related to site initiation, including training, collection of necessary documentation, and access to systems Ensure site monitoring readiness in anticipation of first subject first visit Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; responsible for enrollment support and ensure progress by responding to recruitment issues from investigators Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals e.g. recruitment, data entry timelines, etc. Study Conduct and Close-out Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues Per the Clinical Monitoring Plan/Study Monitoring Plan (CMP/SMP): Ability to conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations Conducts Source Document Review and Source Data Verification of appropriate site source documents and medical records: o Verifies required clinical data entered in the case report form (CRF) is accurate and complete Manages reporting of protocol deviations and appropriate follow-up Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines: o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned o Manages reporting of identified issues and manages follow-up to resolution Documents activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Study Monitoring Plan Ensures all activities are managed by site personnel who are appropriately delegated and trained Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets Review Data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks Review 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 active on a study review and assess training compliance with any new/updated training requirements (i.e., protocol amendment(s), etc.) Conduct Follow-up for Escalated AEM Report Query Check the site/external facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable) Review research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required. Che