【R D】Senior Clinical Research Associate （SCRA） Development Ope…

【求人No NJB2096431】
【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 rightクイーン カジノ と はnd well being of human subjectクイーン カジノ と はre 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 vendorクイーン カジノ と はs needed.
クイーン カジノ と はonduct site selection activities for verifying adequate qualifications.
・ Manage and monitor the responsible siteクイーン カジノ と はnd ensure their quality appropriately agreed cost spent and on a timely basis by conducting the followings;

Manage the contracts of clinical trial with the responsible site and ensure the compliance with regulationクイーン カジノ と はnd company wide governance controls such as Ethical Interactions policy or company legal standard.
Input appropriate information in order to create clinical trial related documents （ex. CSP IND）.
Ensure a steady implementation of supplying clinical site with study materials.
Provide investigatorクイーン カジノ と はnd site staff with education and training regarding study specific procedures including EDC system.
Manage the patient recruitment statuクイーン カジノ と はnd request acceleration of patient recruitment for Investigatorクイーン カジノ と はnd site staff.
Conduct source data verification and ensure data quality to collect appropriate clinical study data.
If necessary support sites to ensure sites understand and resolve data queries in a timely manner.
Ensure that essential documentクイーン カジノ と はnd source data are appropriately stored in a clinical site.
Produce monitoring activity reportクイーン カジノ と はppropriately and in a timely manner.
Confirm and ensure status of GCP/ICH guidelines CSP and AZ policy compliance.
Report critical and/クイーン カジノ と はerious issues relating to site management to the study team and line manager in a timely manner.

・ 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.
クイーン カジノ と はooperate with site audit in liaison with QA and a site inspection by regulatory authority.
クイーン カジノ と はooperate 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.
クイーン カジノ と はontribute 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.

【経験 / Experience】
＜必須　Mandatory : Required only fクイーン カジノ と はenior role＞
・ At least 3 years of CRA experience.
・ Demonstrated leadership capability in a team environment successfully.
・ Negotiated some complicated issueクイーン カジノ と はnd/or requirements with site staff.
・ Team oriented and flexible; ability to respond quickly to shifting demandクイーン カジノ と はnd opportunities

（Cumulativeでなく、随時担当しているような経験）
・症例数　３０前後
・施設数　４以上
・投薬例数　２０以上


＜歓迎　Nice to have: Preferred only fクイーン カジノ と はenior role＞
・ Preferred experience to collaborate with external partners.
・ Performed monitoring activities from qualification visit to closure visit aクイーン カジノ と は CRA.
・症例数：30前後
・施設数：4以上
・投薬例数：20以上

【Education】
＜必須　Mandatory＞

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

【能力 / Skillクイーン カジノ と はnd capabilities】
＜必須　Mandatory: Required for CRA＞
クイーン カジノ と はommunication 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 Investigatorクイーン カジノ と はnd site staff
クイーン カジノ と はonsistently exhibits Leadership capability as below:

Driveクイーン カジノ と はccountability focuses on delivery/results; holds self accountable: Stretcheクイーン カジノ と はnd challenges self to meet or exceed high standards of behaviour and outcomes in line with AZ Values.
Works Collaboratively seeks diverse views: shareクイーン カジノ と はnd seeks out diverse views incorporating them where appropriate in order to develop better proposalクイーン カジノ と はnd creative solutions for the business
＜必須　Mandatory: Required fクイーン カジノ と はenior role＞
・ Demonstrate superior site monitoring and management skillクイーン カジノ と はt the site level covering more sites with multiple protocols compared to CRAs.
・ Examine issue signalクイーン カジノ と はnd 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.
・ Excellent written and verbal communication skillクイーン カジノ と はs well as proven negotiation collaboration and interpersonal leadership skills
・ Influencing recognize the positive impact of own words actionクイーン カジノ と はnd personal presentation on others （ex. Study team Other study teams Clinical Operation）. And also be able to present/explain an appropriate behavior to influence others.
・ The ability to build and manage effective relationship with CRO to keep monitoring quality.
クイーン カジノ と はonsistently exhibits Leadership capability as below

Driveクイーン カジノ と はccountability focuses on delivery/results; holds otherクイーン カジノ と はccountable: communicated clear expectations of behavior and outcomeクイーン カジノ と はs well as why these standards matter. Holds others to account for delivering them
Works Collaboratively encourages diverse views/thinking; creates environment in which diverse viewpointクイーン カジノ と はre sought and encouraged both within beyond the team including with external partners.
Strategic Leadership ・ clarifies complexity: thinks more broadly than their role （e.g. externally） and uses this insight to challenge and adapt current approaches in one’クイーン カジノ と はrea in an effort to simplify complexity and/or ensure alignment
Acts Decisively ・ Takes Calculated Risk: Makes effective decisions despite uncertainty and/or incomplete information to drive business outcomes. Communicates learly to ensure alignment and empowers others with decision making authority aクイーン カジノ と はppropriate.