メディカル・バイオ - 臨床開発モニター
メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

Job Description

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 venders; and other duties, as assigned
- Assures the implementation of project plans for the clients as assigned at the client office, where you will be dispatched
- 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 Fortrea 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 Fortrea travel policy
- Prepare accurate and timely trip reports
- Manage small projects under direction of a Project Manager/Director as assigned
- Serve as lend 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
- Interact with internal work groups to evaluate needs, resources and timelines
- Act as contact for clinical trial supplies and other supplies (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 Visit (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 budget with potential investigators and assist the Fortrea legal department with statements of agreements as assigned
- Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up SAEs
- Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or clinical data management system 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 contacts as assigned
- Perform other duties as assigned by management
- To be dispatched to the client for the project following the clients’ working conditions (working hours/working places)

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

・学士資格（薬学、医学、生物科学、看護などの分野尚可）
・臨床開発モニターとしての３年以上の経験(医薬品、医療機器)
・GCP(Good Clinical Practice) の知識
・英語を使用することに抵抗感の無い方

■職種未経験者：不可