(Sr.) Clinical Research Associate (CRA) CPS (资深)临床研究专员-CPS
Job Summary职位概述: Companion Diagnostics Clinical Research Study of IVD products
Main Tasks & Responsibilities主要工作职责: 1.Contribute country specific aspects in the development of protocol,protocol revisions, amendments and CRF design. 2.Responsible for the management of designated sites in clinical trialincluding: a.Site assessment b.Preparation of the monitoring plan and execution in compliance withvisit frequency and all assigned tasks throughout the study. c.Planning and Execution of Study Logistics Plan, including eventualdelegation of activities to Support Group d.Safety and proper conduct throughout the trial e.Site specific data management 3.Prepare documentation for IRB/EC submission/approval, together withStudy Management per country specific requirements. 4.Prepare and review clinical study agreements and budgets with Studymanager and Contracts group. 5.Ensure procedures are in place for appropriate enrollment of patientsinto the clinical trial. 6.Organize investigator’s start-up meeting and study site initiationmeetings, including training of the external study personnel in the useof the instruments and reagents and software packages for the on-linedata capture and for the computer based e.g. with WinCAEv and trainingin the use of electronica CRFs with remote data entry. 7.Responsible for instrument installation, check and validation(internal and external) for system study. If applicable, prepareworkflow sheet for system studies, together with Study Management. 8.Responsible for logistics of required evaluation/clinical trialmaterial. Informs and monitors sites for correct storage conditions. 9.Preparation of all study binders 10.Perform Investigator Training (Compliance & Technical part). 11.Verify the investigator follows the approved protocol and all GCPprocedures. 12.Verify all research staff and facilities have adequate qualificationsand resources remain adequate throughout the duration of the study. 13.Key contact for communications between the sponsor and theinvestigator; the point of first contact when investigators/sitepersonnel enquire about patient inclusion/exclusion criteria for ongoingtrials. 14.Ensure that observations during studies are correctly tracked andforwarded to the responsible departments in Roche 15.Verify that source data/documents and other trial records areaccurate, complete, and maintained. Regarding the result calculations:ensure the usability of validated computer programs/software and resultcalculation in compliance to applicable SOPs. 16.Communicate deviations from the protocol, SOPs, GCP, and theapplicable regulatory requirements to the investigator. 17.Interprets and evaluates results with respect to the study goals and,if necessary, discuss with the site, the study manager, eg. Interruptionof the study or initiation of additional measurements at the externalsite. 18.Perform troubleshooting for unexpected results according to studymanager or protocol’s requirements. 19.Ensure completion and availability of Study Documentation, togetherwith Study Management 20.Adverse events, concomitant medications, and inter current illnessesare reported in accordance with the protocol. 21.Conduct Study Close-out visits according to monitoring plan. 22.Ensure eCRF and WinCAEv are ready for database lock. 23.Archive Study Records / Database according to guidelines. 24.Responsible for post study sample/reagents/investigational useproducts/instruments disposition completed during the Close-Out visit. 25.Participation in project teams, global conference calls and/ormeetings to review progress of ongoing clinical trials and to assessdevelopment of new projects regarding customer usability, practicabilityand SOP development, to continuously improve quality and efficiency ofthe evaluation team and processes. 26.Contribute to the content of the study report and contribute topublications for journals and congresses. Possible Additional tasks for Senior Position Holders资深职位附加工作职责: 27.Responsible for Investigator Selection (accountability lies withStudy Manager) 28.Provide mentoring, including training on the job, to the new CRAs toensure that their role and contribution is optimized.
Basic Requirements of the Job基本任职资格:
Education& Qualifications教育背景与专业资格: 1.Bio-medical related scientific degree; can vary from a bachelor,master and nursing qualifications. 2.Knowledge of applicable standards an regulations for clinical trialsand lab conduct (International Conference on Harmonization / WHO GoodClinical Practice standards (ICH-GCP), IVD directives, FDA regulations) 3.Practical experience in study monitoring according to global standards(ICH) 4.2-5 years of Clinical laboratory experience 5.Demonstrated experience in computer skills to include Microsoft Word,Excel, and basic templates 6.Basic statistical knowledge 7.Professional use of the English language; both written and oral 8.Open and clear communicator 9.Ability to make sound decisions and analyze and solve problems 10.Conscientious and precise delivery of work even when under pressure
Experience工作经验: At least 2 years of working experience in a clinical/researchlaboratory, or in clinical trial of IVDs/Medical Device/Drug orapplication support.