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【R&D】Clinical Research Associate, Site Management & Monitoring (SMM), Development Operations

Plats Kita-ku, Ōsaka-fu, Japan Jobb-id R-065822 Datum inlagd 11/13/2019

【職務内容 / Job Description

  • Acting as the main line of communication between the sponsor and the investigator.
  • Communicate with Japan Study Leader and third party vendors as needed.
  • Conduct site selection activities for verifying adequate qualifications.
  • Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis.
  • Ensure input the latest site related information in IMPACT at appropriate timing.
  • Participate in-house and/or external clinical trial related meeting (ex. Study team meeting, CRA’s meeting, Investigators’ meeting) including the preparations.
  • Cooperate with site audit in liaison with QA and a site inspection by regulatory authority.
  • Cooperate with resolving the result of SAE reconciliation.
  • Ensure inspection ready TMF regarding site related documents.

In addition to above, Senior CRA also is to

  • Lead a certain number of CRAs (incl. CRO CRAs) to in terms of information management and communication related to site management in study team to keep monitoring quality.
  • Contribute to the development of Clinical Operations Japan by joining some projects or initiatives, e.g. Process Ownership responsibilities, CRA training.
  • Mentor CRAs on monitoring and internal procedures.

【応募資格(経験、資格等)/ Qualification (Experience & Skill etc)

◆◆経験 / Experience◆◆

<必須 / Mandatory

Senior CRA

  • At least 3 years of CRA experience.
  • Demonstrated leadership capability in a team environment successfully.
  • Negotiated some complicated issues and/or requirements with site staff.
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

<歓迎 / Nice to have

Senior CRA

  • Preferred experience to collaborate with external partners.
  • Performed monitoring activities from qualification visit to closure visit as a CRA.

◆◆資格 / License◆◆

<必須 / Mandatory

  • Bachelor’s degree (or equivalent), preferably  in biological science or discipline associated with clinical research

◆◆能力 / Skill-set◆◆

<必須 / Mandatory

  • Communication skill
  • Negotiation skill
  • Spirit of inquiry
  • Ability to manage for delivering the clinical study data.
  • Ability to plan effective monitoring activity
  • Ability to build and manage effective relationship with Investigators and site staff

◆◆勤務地 / Work Location◆◆

  • Osaka or Tokyo

◆◆キャリアレベル / Career Level◆◆

  • C or D (depends on experiece)

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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