Syneos FSP 临床监查员CRA 目前高额入职奖金的发展前景如何(Syneos FSP 临床监查员CRA 目前高额入职奖金主要做什么工作)

Syneos FSP- 临床监查员CRA 目前高额入职奖金的发展前景如何 Syneos FSP- 临... Syneos FSP-临床监查员CRA的职位在医药研发领域具有重要的角色，负责监督临床试验的执行，确保数据的准确性和合规性。随着医药行业的持续发展，临床监查员的需求量持续增长，发展前景非常乐观。此外，高额入职奖金表明公司对于吸引和留住优秀人才的重视。

Syneos FSP- 临床监查员CRA 目前高额入职奖金的发展前景如何(Syneos FSP- 临床监查员CRA 目前高额入职奖金主要做什么工作)

学历要求：本科
工作经验：2年
公司性质：外资（欧美）
公司规模：10000人以上  Syneos Health赛纽仕医药是一家全面整合生物制药解决方案的公司，旨在帮助客户加快推出新疗法的速度。我们站在产品研发的角度，战略性地融合临床研发、医学事务和商业能力，以及时应对最新市场变化。 想了解更多关于我们如何缩短从实验室到现实生活的距离，请访问官网或订阅我们的播客。 JOB SUMMARY Therapeutic Area：Oncology -The Clinical Research Associate will perform monitoring and site management activities for Phase II/III clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently, seeking guidance as needed. JOB RESPONSIBILITIES -Performs site qualification, site initiation, interim monitoring, site management activities 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. 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/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 -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. -Routinely 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 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. Supports subject/patient recruitment, retention and awareness strategies. 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. -May act as primary liaison with study 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 in 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. -Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. QUALIFICATION REQUIREMENTS -Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience -Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements -Must demonstrate good computer skills and be able to embrace new technologies -Excellent communication, presentation and interpersonal skills -Ability to manage required travel of up to 75% on a regular basis