fsp-cra临床监查员(南京)

该职位来源于猎聘 职责描述: Essential Job Duties

• The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties. 2) Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned 3) Responsible for all aspects of site management as prescribed in the project plans 4) General On-Site Monitoring Responsibilities 5) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study 6) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements 7) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review 8) Monitor data for missing or implausible data 9) Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp Drug Development travel policy 10) Ensure audit readiness at the site level 11) Travel, including air travel, may be required and is an essential function of the job. 12) Prepare accurate and timely trip reports 13) Responsible for all aspects of registry management as prescribed in the project plans 14) Undertake feasibility work when requested 15) Participate in and follow up on Quality Control Visits (QC) when requested 16) Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor 17) Might be requested to work in a client facing environment 18) Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE 19) Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems as assigned by management 20) Assist with training, of new employees, e.g. co-monitoring 21) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 22) Perform other duties as assigned by management 任职要求: 【Education/Qualifications】
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). 【Experience】
• A minimum of 2 year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
• Oncology/ immune study experience is acceptable.
• Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Good planning, organization and problem-solving abilities

Ability to work with minimal supervision

Good communication and interpersonal skills

Good analytical and negotiation skills

Computer competency

Fluent in local office language and in English, both written and verbal

Works efficiently and effectively in a matrix environment