Senior CRA

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募集要項

会社概要

同社は海外に本社を置く、グローバルな新薬の研究・開発・販売を行う先進的なバイオ医薬品企業です。

業務内容

Main responsibilities:

• For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out.
  • Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
  • Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current.
  • Provide Local regulatory and legal requirement expertise.
  • Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Company Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
  • Stay abreast of new and/or evolving local regulations, guidelines and policies.
• Ensure audit and inspection readiness of assigned sites.
  • Advise on pre-audit activities for GCP requirements.
  • Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
• Responsible for coaching and mentoring CRAs and providing input into their development.
• Responsible for mentoring CRAs for various aspects of work.
• May be responsible for being the country point of contact for CROs for an assigned study.
• May participate/lead in global/local task forces and initiatives. Responsible for activities as 
• assigned by manager.
  • If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
  • Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
  • If assigned; With guidance, may serve as key point of contact in country/district for assigned study.
• Update Impact/Tesla with country-level information: Country-level planning timelines, LSR 
• assignments, etc.
  • If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
  • If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. 
• Provides feedback on investigators/sites on an on-going basis based on the site performance. 
• Interacts and builds professional and collaborative relationships with peers and site monitors.

応募条件

Minimum requirements:

• Bachelors or equivalent degree
• Site Monitoring Experience: min. 3 years.
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.

Preferred qualifications:

• Degree in health related area (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.

給与

0 - 0 万円

勤務地

東京