Covance Clinical Research Associate II / Senior in Taiwan

Job Overview

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career? We are currently recruiting for a experienced Clinical Research Associate / Snr. Clinical Research Associate ready to join our constantly growing CoSource team. This is a full-time, permanent and office-based position at our Client’s office in PJ.

  • Site monitoring responsibility for clinical studies accordingto Covance Standard Operating Procedures, ICH Guidelines and GCP

  • Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP

  • Assures the implementation of project plans as assigned

  • Responsible for all aspects of study site monitoring including routine monitoring ond close-out of clinical sites, maintenance of study files, conduct of pre-study ond initiation visits; liaise with vendors; and other duties, as assigned

  • Responsible for all aspects of site management as prescribed in the project plans

  • General On-Site Monitoring Responsibilities:

  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data

  • Ensure the resources of the Sponsor and Covance 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 Covance travel policy

  • Prepare accurate and timely trip reports

  • Manage small projects under direction of a Project Manager/Director as assigned

  • Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned

  • Review progress of projects and initiate appropriate actions to achieve target objectives

  • Organize and make presentations at Investigator Meetings

  • Participate in the development of protocols and Case Report Forms as assigned

  • Participate in writing clinical trial reports as assigned

  • Internet with Internal work groups to evaluate needs, resources and timelines

  • Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

  • Responsible for all aspects of registry management as prescribed in the project plans

  • Undertake feasibility work when requested

  • Conduct, report and follow-up on Quality Control Visits (CQC) when requested

  • 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 as assigned

  • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

  • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

  • Assist with training, mentoring and development of new employees, e.g. co-monitoring

  • Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

  • Perform other duties as assigned by management

Education/Qualifications

  • University/college degree (life science preferred), orcertification in a related allied health profession from anappropriately accredited institution, nursing certification,medical or laboratory technology

  • In lieu of the above requirement, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered

  • Thorough knowledge of ICH Guidelines and GCP including abasic understanding of regulatory requirements in othercountries

  • Thorough understanding of the drug development process

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

Experience

  • Minimum of 2 years of clinical research monitoringexperience (including prestudy,initiation, routine monitoring and closeout visits)

  • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE

  • Preferably with Oncology monitoring experience

Job Number 2018-19901

Job Category Clinical Operations

Position Type Full-Time

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