【AstraZeneca】【R&D】Senior Clinical Research Associate（Oncology), Development Operations

■ 職務内容 / Job Description

Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in order to verify that:
・The rights and well-being of human subjects are protected.
・The reported trial data are accurate, complete, and verifiable from source  documents.
・The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).

■Key Responsibilities

• 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.
•  Taking some tasks delegated by Study Leaders if agreed.
•  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＞

•    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＞

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

【Education】

＜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＞

＜Required for CRA＞
• 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
• Consistently exhibits Leadership capability as below:
   ✓ Drives Accountability - focuses on delivery/results; holds self accountable: Stretches and challenges self to meet or exceed high standards of behaviour and outcomes in line with AZ Values.
   ✓ Works Collaboratively - seeks diverse views: shares and seeks out diverse views, incorporating them where appropriate in order to develop better proposals and creative solutions for the business

＜歓迎 / Nice to have＞

＜Required for Senior CRA＞
• 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
• Consistently exhibits Leadership capability as below:

・ Drives Accountability - focuses on delivery/results; holds self accountable: Stretches and challenges self to meet or exceed high standards of behaviour and outcomes in line with AZ Values.
   ・ Works Collaboratively - seeks diverse views: shares and seeks out diverse views, incorporating them where appropriate in order to develop better proposals and creative solutions for the business
• Demonstrate superior site monitoring and management skills at the site level covering more sites with multiple protocols compared to CRAs. 
• Examine issue signals and resolve them with appropriate resolution and timing. 
• Effective problem and conflict resolution skills especially for CRA/Site related issues. Collaborate with other function's experts, if needed.
• Ability to share best practice and lessons learnt actively to improve quality and productivity of the wider monitoring team.
• The ability to build and manage effective relationship with CRO to keep monitoring quality.

【キャリアレベル / Career Level】

D

【勤務地 / Work Location】

Osaka or Tokyo