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CRA(モニター)求人一覧

CRA(モニター)求人一覧

現在、公開されている企業の一覧です。

【新着求人情報】 ・・・ MNT-01公開しました。

※下記求人に関しての問い合わせはこちらへ
            2020/05/28
状況 求人No 資本金 勤務地 スペック 英語力
NEW  MNT-01 113.4億 外資 東京 Sr. Clinical Trial Monitor
【主な仕事内容】
• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies)
• Recommends sites during the site feasibility and/or site selection process
• Conducts pre-study visit as appropriate
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation
• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, ** procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable
• Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
• Serve as a point of contact for Sites
• Provides trainings to sites
• Performs site closure activities when all required protocol visits and follow-up are completed
• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
• Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities.
• Oversees activities of site personnel over whom there is no direct authority.
• Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
• May support Ethics Committee submission, ICF review, collection of documents to/from site
• May support ensuring access to eDC and ** / vendor systems is available for clinical trial site personnel
• May support equipment calibration and tracking
• May support preparation of Study Initiation Visit materials
• May support coordination and ensure database lock timelines are met as required locally
【応募資格】
【Senior Level Expectations】
• Proactively identify and resolve potential problems at both site and country level.
• Engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues.
• Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.
• Contribute significantly to study team and coaches site staff to enhance site and hub performance.
• Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
• May assist line management with conducting monitoring authorizations and ongoing assessments
要 
  MNT-02 22.73億 外資 東京 Senior CRA in Oncology Clinical Operations
【主な仕事内容】
・The senior Clinical Research Associate (Sr .CRA) is accountable and responsible for Country Lead Monitor for assigned oncology studies. The CLM leads assigned Japan local monitoring team and works in close collaboration with global study team. The Sr CRA all aspect of site management and monitoring activities for assigned applicable Phase I and all Phase II -IV clinical investigator sites as CLM. These global, complex studies are conducted with the standards set by Bayer Global Development, according to Good Clinical Practices (ICH-GCP) and applicable regulatory and legal requirement.
・Managing investigator sites and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
・Managing investigator sites to ensure the investigator and site staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
【応募資格】
【Education】
University Degree or above
【Experiences】
・At least 5 years clinical operations experience in the pharmaceutical industry and at least 1-2 years clinical operations experience in the Oncology Field
・At lease 2 years of clinical trail/study management as a leader experience preferred.
※The incumbent is responsible for management of Phase II-IV complex and global/Local clinical trials.
・This requires an in-depth knowledge of oncology field, Good Clinical Practices (GCP), federal reg
【Skills】
・Fluency in Japanese, English TOEIC 730 and above
【Competencies】
・Ensuring accountability and consistently achieving results, even under tough circumstances.
・Recognizing the value that different perspectives and cultures bring to an organization.
・Planning and prioritizing work to meet commitments aligned with organizational goals.
・Stepping up to address difficult issues, saying what needs to be said.
  MNT-03 4億 外資 東京 Senior Clinical Research Associate (Training Specialist)
【Objectives】
・To enable**’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start­up, execution, and close­out of studies.
・Strategic support role aiming to identify training needs, enhance, standardise, and facilitate training solutions for Site M&M Monitors globally
・Optimize and standardise process and materials for new hire onboarding and training across countries and regions
・Support the Country/Region / Area Heads, line managers, and mentors mentors to provide a consistent best-practice approach to onboarding
・Develop the training plans and for all Monitoring roles (e.g., new hire, inexperienced and experienced)
・Coordinate with SME’s and trainers to ensure training materials are available for CRA’s when needed. ・Ensure relevant trainings on new initiatives and activities are incorporated into the training plans
・Consolidate ‘lessons learned’ across other areas (e.g., quarterly forums, including CAPA’s etc.) and regularly incorporate these into the CRA training materials.
・Identify, address, and include Country or Region specific Clinical requirements and differences into training plans and materials as applicable
・Ensure that training plans and optimised materials / tools are housed in Development University, and drive awareness / utilisation of Development University as the online repository for CFO on a functional level.
・Develop and enhance collaboration and alignment with the Global Clinical Training function
・Identify and leverage skills and knowledge of Functional, Regional, or Country based resources (e.g, GMA, Commercial, TA Leads, CPD, GCT etc) to ensure that Site M&M personnel receive training on all areas affecting our business (e.g., Therapeutic Area training, Systems, Regulatory processes, Tools etc.) where they may not have do no have expertise themselves.
【Qualifications】
・Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
・Site Monitoring Experience: Minimum 3 years.
・Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making
・Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
・Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
  MNT-04 82.52億 国内 大阪 CRA(臨床開発モニター)
【主な業務内容】
担当製品/プロジェクトの臨床開発において、治験が治験実施計画書に従って実施されるようモニタリングを実施するとともに、科学性、倫理性、信頼性の確保されたデータを期限内に収集することで、製品の早期上市に貢献いただきます。(※担当施設は6施設程度です。)
【具体的には】
◆担当製品/プロジェクトの進捗管理および症例報告書の回収・点検
◆治験関連書類およびモニタリング報告書の作成
◆担当プロジェクトに関連した情報(競合品情報含む)の収集
◆CROのマネジメント
Globalな研究開発組織の中で、まずは国内施設のCRAとして経験を積んでいただき、ゆくゆくはGlobalに活躍の幅を広げていただくことを期待しています。
【登録資格】
【求める経験・スキル】
◆製薬会社でのCRAのご経験(目安:3年以上/3施設/3プロトコール程度)
◆組織や機能を横断したプロジェクトのご経験
◆英語でのコミュニケーション能力(抵抗なくメールでのやりとりができる程度)
◆文章作成スキル(Word、Excel、PPT)
【上記に加え、あれば望ましい経験・スキル】
◇大学病院等の基幹病院でのCRAのご経験
◇**領域でのCRAのご経験
◇当局申請に必要な書類作成のご経験
要 
  MNT-05 10億 外資 東京 Clinical Research Associate (CRA)
【仕事内容】
管理職候補(Study Leader候補)として、リーダーシップを発揮し、以下の業務をご担当いただける方を求めています
[概要]
治験の実施に関わる施設選定~データベースロック/治験終了までのモニタリング業務
[具体的な業務例]
・治験契約締結交渉・IRB申請手続き
・治験契約締結後の施設セットアップ、医療関係者トレーニングの実施
・症例登録促進活動の実施、GCP・SOPに基づくモニタリング
・治験の質的管理、原資料等の直接閲覧/症例報告書のSDV実施
・施設における治験費用の管理
・その他、Japan Clinical Trial Team Memberとしての活動
【資格】
【職務経験】
【必須】
・治験実務あるいはモニタリング業務経験 3年以上を目安とする
・Global Processに基づく治験実務担当経験
※グローバル試験の経験がない場合、Speakingも含め英語力が高いこと
・単独で治験の施設を担当し,GCPに従ったモニタリング業務の遂行
・治験の実務を通じて、後輩社員の指導あるいは補助の担当経験
【尚可】
・免疫系、中枢神経系、抗がん剤開発実務経験
・大学病院、国公立病院等への依頼による治験実務担当経験
【必要とする能力・スキル】
・少なくとも英語での読み書きができる(目安としてTOEIC 650点以上)
・パソコン等:Word,Excel,PowerPoint,EDCやCTMSなどのシステムが使える
【資格/免許】
・特になし
要 
  MNT-06 4億 外資 東京 Site Clinical Research Associate
Primary Goals/ Objectives
?Monitors activities conducted by clinical investigative sites as they relate to ** clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity. ?The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring ** studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites. Education
?Bachelor’s Degree required; medical/science/nursing background is preferred.
Background (Experience)
?Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
?Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
?Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
?Experience in on-site monitoring of investigational drug or device trials is required.
Required Functional Competencies
?Demonstrated strong site management and monitoring skills.
?Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
?Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
?Acute observational skills, analytical and conceptual capabilities.
?Exhibits high degree of flexibility when facing changes in the work environment.
?Attention to detail and strong interpersonal skills.
?Competence in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
?Previous experience with electronic data capture systems is desirable.
?Ability to work independently with minimal supervision.
?The SCRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The SCRA should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
Good written and verbal communication skills. Written and verbal fluency in English and local language (if not English)
            

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