Nom du site:
China - Sichuan - Chengdu - JinJiang District - Building Baiyang Data de publication:
Feb 19 2021
Job Purpose and Key Responsibilities: Responsible for monitoring of all types of clinical studies with a high degree of independence Ensures clinical studies are conducted in accordance with protocol, SOP/guidance, GCP and local regulations Develop and maintain excellent working relationships with external and internal customers to ensure the smooth ongoing and timely delivery of clinical studies If need, Perform other tasks assigned by line manager As required, assist the Local delivery Lead(LDL) with particular tasks As required, being a mentor for junior CRAs and conduct co-monitoring
Accountability: Prepare, conduct and report on pre-study visits; Identify potential investigators and check Site staff/facility qualifications Prepare, conduct and report on Site Initiation visits; Ensure investigator has submitted regulatory documents to IEC as required; Co-ordinate shipment and review storage/dispensing of IP and other study related materials Prepare, conduct and report on Site Monitoring visits; Performs source data verification and CRF review, verifies informed consent form completion, IEC filing documents and subject eligibility, verifies investigational product management; ensures AEs and SAEs have been reported as per the protocol, performs other relevant monitoring tasks and resolves queries; Maintain regular telephone contact with investigators and written correspondence with site; Track investigator payment Prepare for, conduct and report on Study Closure visit; Retrieve CRFs if applicable; Resolve outstanding queries and issues; Ensure regulatory documents available and updated; Ensure IP and study material accounted, returned and destroyed if required; Ensure site closure summary and study report submission to EC; Ensure final payment processed to investigators Attend inv meeting and ensure inv to join the meeting; prepare and deliver the presentation in inv meeting; conduct site and prepare the meeting materials Evaluates the quality and integrity of study sites performance; Verifies the continuing compliance of the site with applicable regulatory and ethical requirements and the protocol/amendments; Reports relevant activities and findings in MVR and follow-up letter, escalates study-related issues to internal stakeholder and PI and investigators, and proactively follows them up until resolution Obtain and maintain essential documentation in compliance with ICH GCP, SOPs and local regulations at Investigator sites and Sponsor site; Ensure they are complete and correct Responsible to set site recruitment plan and deliver patients to the plans (actual versus planned) Updates and maintains clinical metrics data via clinical study tracking tools such as eTrack Complete and pass new starter assessment and programme; Complete all required SOP/guidance/regulations training and reading; Share and drive best practice with team members; Attend and actively contribute to meetings and trainings Prepare for, participate, respond and follow up to Clinical Quality Audit, QC and co-monitoring findings at investigator sites. Prepare and implement an action plan to improve compliance if needed Perform other tasks assigned by line manager Perform and lead study specific tasks assigned by LDL Serve as mentor and conduct co-monitoring to CRAs in conjunction with LDL Act as eTrack Local Expert, following the responsibilities defined by World Wide Development & Local Country Medical Departments
Behavior : Flexible Thinking: Seeing different perspectives on issues and usually being able to generate alternative options one after the other, rather than at the same time; Valuing alternative options for the way forward suggested by others Continuous improvement: Being aware and making general statements of the need to improve performance Customer Driven: Making general statements about the importance and value of customers, but taking no specific actions Enable and drive change: Responding to the plans of others. Expressing frustration at obstacles to the delivery of results Building Relationships: Being aware of the value of the contribution of others. Listening to the points of view of others carefully
Complexity: The holder will need to interact with multiple GlaxoSmithKline team members involved in running the trial including CTAs and LDLs The holder may be involved in providing assistance to more than one trial each of which may have multiple sites The holder will need to interact with and manage the expectations of both internal and external stakeholders The holder will need to develop relationships with multiple site members across multiple sites
Specialized Knowledge: breadth & depth across disciplines or functions; expertise in field required; separate by basic and preferred
Able to complete complicated tasks high independently, able to perform and lead study specific task, capable of providing coaching to junior CRAs and sharing best practice with team staff.
Bachelors degree in clinical medicine or a life/biological science Familiarity with Good Clinical Practice and relevant local regulations Good command of spoken and excellent written English and able to read it accurately Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and familiarity with the internet At least 2 years monitoring experience in the top pharmaceutical or CRO
Notre objectif est d'être l’une des entreprises les plus innovantes, les plus performantes et dignes de confiance de l'industrie pharmaceutique. Nous pensons que nous apportons quelque chose d'unique chez GSK et lorsque nous associons nos connaissances, nos expériences et nos styles, l'impact est incroyable. Venez rejoindre notre aventure chez GSK où vous trouverez l'inspiration pour faire au mieux votre travail pour nos patients et pour nos clients. Un endroit où vous pouvez vous recentrer, vous sentir bien et aller de l'avant.
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