Sr. / Clinical Research Associate

工作描述
• Manage / Contribute to the study site selection process by preparingfeasibility questionnaires an******** site interviews.
• Organize investigator’s start-up meeting an******** site initiationmeetings.
• Develop various study specific form******** an**************** managesstudy status reports.
• Assist in vendor set-up, an******** of vendors (including clinicalCROs).
• Review essential documents from study sites for accuracy an********.Request set-up of TMF an******** for reconciliation of require********.
• Supporting the CPM to handle issues when investigator********personnel enquire about patient inclusion/exclusion criteria for ongoingtrials.
• Conduct co-monitoring visits with the CPM: coordinate with clinicalinvestigators in the timely complet******** subm******** an******** ofCRFs an******** report data against protocol an******** files.
• Assure compliance for assigne******** with clinical research policiesan********.
• Manage progress by tracking regulatory subm******** recru******** casereport form (CRF) complet******** an******** query resolution.
• Contribute to the review of all SAEs, ensure Medical Directorsign-off, site notification an******** with all company procedures.
• Manage clinical aspects of database lock by participating in datalisting revie********
• Provide guidance to product supply process an******** site shipmentsin alignment with the Clinical supply group.
• Contribute to clinical study ******** proposals, an********.
• Contribute to patient recruitment strategies to increase patientrandomization into the trial (eg investigator an******** nursemeet******** newsletter updates).
• Involvement in project follow-up (time plann******** bu********project meetings) in collaboration with the CPM.
• Contribute to the Global Project Team for the assigne******** (Coreteam member).
• Support junior CRA/CTA training.
• Contribute to the improvement of departmental procedures ( eg GCPmonitoring aspects etc).

职位要求
• Comprehensive knowledge an******** of China drug an******** deviceGoo******** Practices required.
• Has ability to understan******** disease under study an******** aim ofthe therapy. Shoul******** able to understan******** relevant sectionsof the study protocol. Monitoring experience preferred.
• Has ability to maintain effectiveness under changing circumstancesan******** an******** be able to handle multiple projects at a timean******** strong attention to detail while keeping the global picture.
• Must be able to expan******** an******** to an increasingly complexenvironment.
• Must be capable of interacting with all levels of management,coworkers, investigators an********.
• Excellent verbal an******** commun******** presentat********interpersonal an******** skills require******** the ability tobuil******** relationships with site staff an********.
• Proactive approach, tact an******** strongly required.
• This position requires a soun******** of computer software an********attention to detail.
• Must have experience in Electronic Data Capture (EDC) system.
• Shoul******** process-oriente******** shoul******** a sense of urgencyin completing deliverables through effective goal setting an********strong result orientation.
• Strong organ******** ******** an******** skills.
• Bachelor’s degree / Master’s degree in scientific discipline orequivalent.
• Minimum of 2-3 years clinical monitoring experience in apharmaceut******** b******** or medical device industry.
• Excellent comman******** spoken an******** English.
Preferred:
• BA/BS/Nursing education and/or equivalent clinical researchexper******** preferably above 2-3 years of clinical exper******** e.g.CRA in pharmaceut******** biotechnology or medical device companyincluding CRO. Degree in B******** Chemistry or other life sc******** ifless than 3 years clinical operations experience. Monitoring experienceor other long-term site management experience required.