Sr CRA

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8pnury

Sr CRA
- FSP (Global Pharma Dedicated)
- Homebased in Romania Non aspetti a candidarsi dopo aver letto questa

descrizione:
per questa possibilità è previsto un elevato volume di candidature. Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Why Syneos Health technical and therapeutic area training; We are committed to building an inclusive culture – where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) 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 serious 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. 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/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within 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 requirements May perform 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. Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned clinical operations lead tasks unde

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8pnury